Getting Medicines to Market Faster

News

EMA has updated its procedural guidance

Monday 1st of September 2014
European Medicines Agency updates guidance on European Union periodic safety update report single assessment for nationally authorised medicines.
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Health Product Regulatory Agency Update

Thursday 28th of August 2014
Application form for Variation or Immediate Notification of Change to Registration of Manufacturer, Importer or Distributor of Active Substances.
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Generic Drug Development

Wednesday 27th of August 2014
Controlled Correspondence Related to Generic Drug Development by the US Food and Drug Administration (FDA).
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FDA update

Tuesday 19th of August 2014
Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products-Considerations, Content, and Format
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"Blue-Box" requirements

Thursday 14th of August 2014
Additional information on labelling/package leaflet that may be required nationally in accordance with Articles 57 and 62 of Directive 2001/83/EC as amended is outlined.
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EDQM update

Monday 11th of August 2014
Guideline on requirements for revision/renewal of certificates of suitability to the European Pharmacopoeia monographs revised.
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EMA update

Friday 8th of August 2014
Europe to boost cooperation with international partners on generics. European system to be used as model to facilitate assessment of medicines.
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FDA update

Thursday 7th of August 2014
Guidance for Industry Providing Regulatory Submissions in Electronic Format.
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EMA update

Tuesday 5th of August 2014
European Medicines Agency consults on updates to its policy on access to EudraVigilance.
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EMA update

Friday 1st of August 2014
European Medicines Agency publishes first public summaries of Paediatric Committee evaluations of paediatric investigation plans.
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MHRA update

Tuesday 22nd of July 2014
Medicines and Healthcare products Regulatory Agency (MHRA) Press release: Fentanyl skin patches - use and dispose of safely says regulator
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Guide to Cosmetics

Monday 21st of July 2014
An introductory guide and the legislation applicable to responsible persons (including manufacturers, importers and designated responsible persons) and distributors.
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Legal Classification

Thursday 17th of July 2014
Health Products Regulatory Authority (HPRA) published a list of twelve active substances suitable for Reclassification (Switching).
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FDA Update

Wednesday 16th of July 2014
Guidance for Industry ANDA Submissions-Prior Approval Supplements Under GDUFA DRAFT GUIDANCE.
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FDA update

Tuesday 15th of July 2014
FDA encourages Generic industry to comment on draft Chemistry Question based Review (QbR) questions.
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Medicines Recommended for Marketing Authorisation in First Half of 2014

Friday 11th of July 2014
European Medicines Agency recommends 39 medicines for human use for marketing authorisation in first half of 2014.
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EMA update

Thursday 10th of July 2014
Management Board delays formal adoption of EMA publication of clinical trial data policy to October 2014.
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CMDh update

Friday 4th of July 2014
CMDh questions and answers Pharmacovigilance Legislation Regulation (EU) no 1235/2010 and Directive 2010/84/EU
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IMB update

Thursday 3rd of July 2014
Information for Marketing Authorisation Holders regarding Section 4.8 of the SmPC and Section 4 of the PIL.
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FDA Update

Wednesday 2nd of July 2014
FDA outlines expectations for human drug compounders, including registered outsourcing facilities.
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FDA safety update

Friday 27th of June 2014
FDA warns of rare but serious hypersensitivity reactions with certain over-the-counter topical acne products.
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European collaboration between regulators and HTA organisations

Thursday 26th of June 2014
Report on improving the contribution of regulatory assessment reports to health technology assessment.
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EMA update

Wednesday 25th of June 2014
European Commission launches logo for online pharmacies to protect patients from falsified medicines.
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Saftey update by FDA

Friday 20th of June 2014
Potential Signals of Serious Risks/New Safety Information Identified by FAERS between January – March 2014.
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EMA update

Thursday 19th of June 2014
Posting of clinical trial summary results in European Clinical Trials Database (EudraCT) to become mandatory for sponsors as of 21 July 2014
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Guidance for Industry

Wednesday 18th of June 2014
Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions.
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Regulatory information

Tuesday 17th of June 2014
Companies now required to update, complete and improve quality of information on authorised medicines submitted to the European Medicines Agency.
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EMA starts review of ibuprofen medicines

Monday 16th of June 2014
The EMA's PRAC has started a review to evaluate the cardiovascular risks with systemic ibuprofen medicines.
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Irish Medicine Board Update

Thursday 12th of June 2014
Information on the introduction of additional monitoring requirements for certain medicinal products for which there may be limited data/experience.
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Generic versions of celecoxib

Wednesday 11th of June 2014
FDA approved the first generic versions of Celebrex capsules, a treatment for rheumatoid arthritis, osteoarthritis, short-term (acute) pain, and other conditions.
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Public consultation opens on European Medicines Agency’s draft guide on monitoring of medical literature

Tuesday 10th of June 2014
EMA has released a draft guide on the monitoring of medical literature and the entry of information into the EudraVigilance database.
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Adaptive licencing

Monday 9th of June 2014
European Medicines Agency selects first two medicines to be included in its adaptive licensing pilot project.
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Revised guideline on acceptability of names for human medicines is published

Thursday 5th of June 2014
The European Medicines Agency has published a revised guideline on the acceptability of names for human medicines processed through the centralised procedure.
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Expedited Programs for Serious Conditions – Drugs and Biologics

Friday 30th of May 2014
The FDA programs are intended to facilitate and expedite development and review of new drugs.
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Clinical Trials Regulation

Thursday 29th of May 2014
The European Medicines Agency (EMA) welcomes the publication of the Clinical Trials Regulation in the Official Journal of the European Union.
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Notice to applicants, medicinal products for human use

Wednesday 28th of May 2014
The update of chapter 3 of volume 2A of the notice to applicants is published and available.
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Final European safety report about PIP silicone breast implants

Tuesday 27th of May 2014
MHRA shared the final European report about the safety of the fraudulently manufactured PIP silicone breast implants.
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FDA approves first molecular (gene-based) test

Friday 23rd of May 2014
FDA approved the Immucor PreciseType Human Erythrocyte Antigen (HEA) Molecular BeadChip Test - the first FDA -approved molecular assay used in transfusion medicine.
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First draft finished product monograph with chemically defined active substance published for comment

Thursday 22nd of May 2014
European Pharmacopoeia Commission working on monographs for finished products containing chemically defined active substances.
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Report from the CMDh meeting

Wednesday 21st of May 2014
Co-ordinationGroup for Mutual Recognition and Decentralised Procedures-Human has published report from meeting held on 22nd, 23rd and 24th April 2014 on key issues.
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Questionnaire on Maximum Residue Limits (MRLs)

Tuesday 20th of May 2014
The aim of this questionnaire is to gather information from authorities and stakeholders on their experiences with the MRL-Regulation.
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The benefits and risks of statins

Monday 19th of May 2014
Following recent media coverage about side effects associated with statins, the MHRA has published its position on their benefits and risks
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FDA requiring lower starting dose for sleep drug Lunesta

Friday 16th of May 2014
FDA announced it required the manufacturer of the sleep drug Lunesta (eszopiclone) to change the drug label and lower the current recommended starting dose.
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EMA and FDA release joint proposal to facilitate clinical investigation of new medicines

Thursday 15th of May 2014
The EMA and FDA have released a draft joint proposal to facilitate the clinical investigation of new medicines for the treatment of Gaucher disease in children
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FDA guidance for industry ANDA's - MAY 2014

Wednesday 14th of May 2014
This guidance provides answers to questions from the public comments FDA received on the draft guidance for industry on ANDAs.
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TATFAR reports progress and outcomes of 17 recommendations

Tuesday 13th of May 2014
The report outlines the progress and outcomes to date of the 17 recommendations to fight antimicrobial resistance (AMR) that are being implemented by the taskforce.
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FDA allows marketing of first prosthetic arm.

Monday 12th of May 2014
FDA allowed marketing of the DEKA Arm System, the first prosthetic arm that can perform multiple, simultaneous powered movements controlled by electrical signals.
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EMA releases best practice guidance on parallel scientific advice with HTA bodies

Friday 9th of May 2014
The EMA has published best practice guidance for pilot parallel scientific advice procedures involving the EMA and health-technology-assessment (HTA) bodies.
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Regulator warns people about buying potentially toxic herbal medicines online

Thursday 8th of May 2014
MHRA is warning people not to use a number of herbal medicines that can be bought on the internet after they were found to contain heavy metals.
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FDA requires label changes to warn of rare but serious neurologic problems

Wednesday 7th of May 2014
The FDA is warning that injection of corticosteroids may result in rare but serious adverse events, including loss of vision, stroke, paralysis, and death.
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One-year report on human medicines pharmacovigilance tasks of European Medicines Agency

Tuesday 6th of May 2014
The EMA has presented with its first report on the tasks it undertook during the first year of application of the EU’s new pharmacovigilance legislation.
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FDA approves Zykadia for late-stage lung cancer

Friday 2nd of May 2014
The FDA granted accelerated approval to Zykadia (ceritinib) for patients with a certain type of late-stage (metastatic) non-small cell lung cancer (NSCLC).
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End of herbal sell through period

Thursday 1st of May 2014
MHRA is reminding herbal companies and retailers that, as of 1st May 2014, unlicensed manufactured herbal medicines without a THR or PL can no longer be sold.
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2013 annual report on EudraVigilance: over 1 million adverse reaction reports received and processed

Wednesday 30th of April 2014
In 2013, EudraVigilance received more than one million post-marketing expedited adverse-drug-reaction (ADR) reports.
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CMDh confirms recommendations on restricting use of domperidone-containing medicines

Tuesday 29th of April 2014
The CMDh has endorsed recommendations to restrict the use of domperidone-containing medicines.
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European Medicines Agency recommends approval of Mekinist for the treatment of melanoma

Monday 28th of April 2014
First MEK inhibitor to receive a positive opinion in the EU for the treatment of adult patients with unresectable or metastatic melanoma.
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EC/EMA-FDA bilateral - update

Friday 25th of April 2014
This meeting provided an opportunity for the new leadership team at the EMA and FDA to explore the possible impacts of changes on a number of bilateral projects.
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The technical guidelines in accordance with Article 57(2)

Thursday 24th of April 2014
The technical guidelines (Chapter 3.I and Chapter 5) related to data submission in accordance with Article 57(2) of Regulation 726/2004 have been republished.
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EMA and EU national competent authorities agree on action plan to address medication errors

Wednesday 23rd of April 2014
The European Medicines Agency and the National Competent Authorities of the European Union (EU) have agreed an action plan to address the issue of medication errors.
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European Medicines Agency update on stolen vials of Herceptin

Tuesday 22nd of April 2014
This is an update from the European Medicines Agency on the latest information relating to the stolen vials of Herceptin (trastuzumab) in Italy.
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Post-authorisation Efficacy Study

Thursday 17th of April 2014
EU specifies the situations where a post-authorisation efficacy study can be required by medicines regulatory authorities.
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EMA announces final steps for its clinical-trial data policy

Wednesday 16th of April 2014
EMA to consult with key stakeholders on its draft policy
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PRAC meeting highlights

Tuesday 15th of April 2014
Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights from the 7-10 April 2014
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MHRA announces new scheme

Monday 14th of April 2014
Early access to medicines scheme- applications (EAMS) started on 7 April
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MHRA Safety warnings and messages for medicines

Friday 11th of April 2014
Information sent to healthcare professionals in March about the safety of the medicines
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MHRA release Medical Device Alerts list

Thursday 10th of April 2014
Monthly PDF list of Medical Device Alerts in 2014
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EU Memo on Clinical trials

Wednesday 9th of April 2014
New rules for clinical trials conducted in the EU
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EMA Increased Fees

Tuesday 8th of April 2014
Increased fees came into effect on 1 April 2014
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New EMA Fee Incentives

Monday 7th of April 2014
European Medicines Agency introduces new fee incentives for SMEs for post-authorisation activities
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FDA Clarification on Revatio

Friday 4th of April 2014
FDA clarifies Warning about Pediatric Use of Revatio (sildenafil) for Pulmonary Arterial Hypertension
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New FDA Approval

Thursday 3rd of April 2014
FDA approves Topamax for migraine prevention in adolescents
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EMA revises Guildlines

Wednesday 2nd of April 2014
Revisions on the format and content of applications for designation as orphan medicinal products
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FDA Warning

Tuesday 1st of April 2014
FDA warns consumers not to purchase or use weight loss product Alli
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EMA reorganisation

Monday 31st of March 2014
Changes to handling of certain evaluation procedures for human medicines to be introduced from 1 April 2014
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Initiative to simplify adverse incident reporting

Friday 28th of March 2014
MHRA and NHS England jointly issued two patient safety alerts and supporting guidance
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CMDh endorses recommendations to restrict the use of diacerein-containing medicines

Thursday 27th of March 2014
Restrictions intended to limit risks of severe diarrhoea and effects on the liver
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EMA recommends authorisation of first medicine for Castleman's disease

Wednesday 26th of March 2014
The CHMP has recommended the granting of a MA for Sylvant (siltuximab), a medicine for the treatment of adult patients with multicentric Castleman’s disease.
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EMA recommends approval of new treatment for platinum-resistant ovarian cancer

Tuesday 25th of March 2014
Which includes approval for the companion diagnostic
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EMA launches adaptive licensing pilot project

Monday 24th of March 2014
The project aims to improve access to new medicines for patients
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New IMB guidance

Friday 21st of March 2014
Guidance on training, education and competency assessment under Directive 2010/63/EU and S.I. No. 543 of 2012
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MHRA announces early access to medicines scheme

Thursday 20th of March 2014
Aims to give patients with life threatening or seriously debilitating conditions access to medicines that don't yet have a MA
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EMA publishes first summary of a RMP

Wednesday 19th of March 2014
Initiative increases transparency and public access to relevant information on medicines
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New PRAC recommendations

Thursday 13th of March 2014
PRAC recommends product information of zolpidem be updated with new advice to minimise the risk of next-morning impaired driving ability and mental alertness
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Two-year extension for the parallel evaluation of quality-by-design (QbD) applications.

Wednesday 12th of March 2014
EMA and FDA extend pilot programme for parallel assessment of quality-by-design applications
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Pharmacovigilance Risk Assessment Committee

Tuesday 11th of March 2014
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3-6 March 2014
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EMA Fees to change on 1 April 2014

Monday 10th of March 2014
Adjusted fees for applications to European Medicines Agency from 1 April 2014
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FDA release new draft guidance

Friday 7th of March 2014
Distributing Recommended Practices on Distributing Scientific and Medical Publications on Unapproved New Uses
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FDA approves new drug

Thursday 6th of March 2014
FDA approves Myalept to treat rare metabolic disease
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Obesity Plan

Wednesday 5th of March 2014
EU Member States agree Plan to tackle Childhood Obesity
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EMA celebrated Rare Disease Day 2014

Tuesday 4th of March 2014
Rare Disease Day 2014 – twelve new orphan medicines available to patients over the past year
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Former chief executive of MHRA has article published

Monday 3rd of March 2014
Explanation of medicines and medical devices regulatory systems is published in Clinical Medicine
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FDA and EMA strengthen collaboration in pharmacovigilance

Friday 28th of February 2014
EMA and FDA have set-up new collaborative meetings on pharmacovigilance (medicine safety) topics
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Merck Sharp & Dohme Limited Recall COSOPT Preservative-Free

Thursday 27th of February 2014
Class 2 Medicines Recall on COSOPT Preservative-Free, 20mg/ml +5mg/ml, eye drops, solution, single-dose container
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MHRA advice on osteoporosis medicine

Wednesday 26th of February 2014
New advice on Protelos to be issued
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Herbal advertising Ban

Tuesday 25th of February 2014
Promotion of an unlicensed indication for Echinacea traditional herbal remedies by Holland & Barrett
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CHMP recommended 10 new medicines

Tuesday 25th of February 2014
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 February 2014
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FDA Is Committed to Determining Sex Differences in How Drugs Work

Friday 21st of February 2014
FDA issues guidance explaining expectations about analyzing clinical data for sex-related differences.
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Classification of variation categories

Thursday 20th of February 2014
EMA clarifies interpretation of new variation classification categories
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EMA to extend the use of eSubmission Gateway

Wednesday 19th of February 2014
From 1 April 2014, the EMA will extend the use of the eSubmission Gateway and web client to all referral procedures, veterinary medicine submissions and paediatric submissions.
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EMA introduces (UPIs)

Tuesday 18th of February 2014
EMA introduces unique product identifiers (UPIs) to track medicines through pre-authorisation procedures
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Sharing medical data

Monday 17th of February 2014
Prof Peter Johnson on why sharing medical data is for the greater good.
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EU launches the rapid alert platfrom

Friday 14th of February 2014
New EU Rapid Alert platform for human Blood and Blood Components
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EU GMP guidelines revised

Thursday 13th of February 2014
Revision of European Commission Guidelines on Good Manufacturing Practice for Medicinal Products
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Committee for orphan medicines overview of 2013

Wednesday 12th of February 2014
EMA's committee for orphan medicines overview of 2013
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New EMA guidelines

Tuesday 11th of February 2014
EMA release guidelines on best practice with regard to 3Rs (replacement, reduction and refinement) in regulatory testing of medicinal products
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Submission Gateway or web client mandatory

Monday 10th of February 2014
Submission Gateway or web client mandatory for all eCTD submissions through the centralised procedure from 1 March 2014
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S10 Guideline reaches Step 4

Friday 7th of February 2014
ICH S10 Guideline reaches Step 4 of the ICH Process
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FDA approves Hetlioz

Thursday 6th of February 2014
FDA approves Hetlioz: first treatment for non-24 hour sleep-wake disorder in blind individuals
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FDA evaluating risk of stroke, heart attack and death

Wednesday 5th of February 2014
FDA evaluating risk of stroke, heart attack and death with FDA-approved testosterone products
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CMDh January Report

Tuesday 4th of February 2014
CMDh release report from their January meeting
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MA holders next step for maintenance

Monday 3rd of February 2014
EMA announces the next steps for the maintenance of information on authorised medicines by MA holders.
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IMB Changes Variations Procedure

Friday 31st of January 2014
The latest IMB Newsletter details changes in the procedure for issuing variations.
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FDA Approvals down in 2013

Thursday 30th of January 2014
The FDA approves fewer new drugs in 2013, but acts faster on innovative products.
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EMA Q&A's on Pharmacovigilance

Wednesday 29th of January 2014
The EMA has published a questions and answers document on Article 31 pharmacovigilance referrals
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Blue Box labeling changes

Tuesday 28th of January 2014
Danish ‘Blue Box’ labeling requirements have been revised.
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EMA recommends 81 medicines for MA

Monday 27th of January 2014
The value of Scientific Advice is borne out by the EMA’s 2013 MA approval statistics.
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EMA guidance on stats for biosimilars

Thursday 23rd of January 2014
The EMA looks to providing guidance on stats to be used when comparing quality data (‘critical quality attributes’, CQAs) in the biosimilar setting.
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EMA Revises XEVMPD Documents

Wednesday 22nd of January 2014
Several Extended EudraVigilance product report message (XEVMPD) documents have been revised.
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eCTD in the Czech Republic

Tuesday 21st of January 2014
eCTD is now mandatory in the Czech Republic
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New EU Clinical Trials Regulation

Monday 20th of January 2014
The new EU Clinical Trials Regulation is likely to be approved this April.
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PRAC Osteoporosis Recommendation

Thursday 16th of January 2014
PRAC has recommended that Protelos/Osseor should no longer be used to treat osteoporosis.
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EMA Newsletter

Wednesday 15th of January 2014
The EMA has published its latest newsletter for SME.
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CMDh update on how to request MS to act as RMS

Tuesday 14th of January 2014
Updated advise on how to request MS to act as RMS in an multistate procedure has been issued by the CMDh.
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Updated Variation Q & A's

Monday 13th of January 2014
The CMDh has updated its Q & A on variations.
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EDQM counterfeit medicines publications free

Friday 10th of January 2014
A number of free publications on counterfeit medicines are now available from the EDQM
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A new EMA / FDA inspection initiative annouced

Thursday 9th of January 2014
The launch of an EMA / FDA generic medicines application inspections initiative has been announced
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MHRA's Orange Guide now available

Wednesday 8th of January 2014
The eighth edition of the Rules and Guidance for Pharmaceutical Manufacturers and Distributors (‘Orange Guide’) is now available
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New version of the EudraGMDP launched by EMA

Tuesday 7th of January 2014
Statements of non-compliance with GMP are now publicly available in new version of the EudraGMDP database
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Updates to Ireland's Fees Guide

Monday 6th of January 2014
The IMB has updated its Guide to Fees and also its Fee Application Form for Human Products
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UK Drug Driving Offence Affects Medicines Packaging

Friday 20th of December 2013
The new UK drug driving offence comes into force in the summer of 2014 – implications for medicines packaging.
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New Guide on Labels and Leaflets for Ireland

Thursday 19th of December 2013
The IMB has updated its guide on labels and leaflets of human medicines
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HMA Updates PSUR Work Sharing Scheme

Wednesday 18th of December 2013
HMA updates the list of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised.
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EMA Updates GvP Documents

Tuesday 17th of December 2013
A number of GvP documents and associated guidance documents have been updated / issued by the EMA
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EMA Publishes its Antimicrobial Resistance Workshop Report

Tuesday 17th of December 2013
The EMA publishes its report on a workshop that discussed regulatory options in the fight against antimicrobial resistance
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CMDh Updates its Guide for Transitional Arrangements for PSUR Worksharing

Tuesday 17th of December 2013
The CMDh best practice guide for transitional arrangements for PSUR worksharing and its Annex 1 - EU PSUR worksharing assessment report template - has been updated
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CMDh Will Reform the MRP and DCP Procedure

Thursday 12th of December 2013
The CMDh has agreed to several reforms of the MRP and DCP procedure following a meeting with interested parties.
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EMA Releases Information on ASMFs Work Sharing Procedure

Wednesday 11th of December 2013
Information for stakeholders has been issued on the work sharing procedure for the assessment of Active Substance Master Files (ASMFs)
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EMA Releases new Concept Paper on THR Products

Tuesday 10th of December 2013
A concept paper has been released on the second revision of the guideline on the use of the CTD format in the preparation of a registration application for a THR product
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Fees Lowered for Orphan Medicines

Monday 9th of December 2013
The EMA applies greater fee-reduction rates for orphan medicines in 2014
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Pharmacovigilance Improvements

Friday 6th of December 2013
The MHRA starts work to improve EU pharmacovigilance capabilities
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Published responses to the revision of Annex 16

Thursday 5th of December 2013
Responses to the public consultation on the revision of Annex 16 (Certification by a Qualified Person and Batch Release) have been published.
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New Guidelines for QPs in Ireland

Wednesday 4th of December 2013
The IMB has updated its guide on the attainment of Qualified Person status in Ireland
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New EU GDP of medicinal products guidelines

Tuesday 3rd of December 2013
A new version of the guidelines on good distribution practice (GDP) of medicinal products is now available
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The MHRA wants your Views!

Monday 2nd of December 2013
Views sought by the MHRA on draft patient safety alerts for medical device incidents and medication errors
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All herbal medicinal products sold in the UK will need a MA or THR

Friday 29th of November 2013
The MHRA declares the end of 'sell through' of unlicensed herbal remedies from the 1st May 2014.
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World Will Spend $1 Trillion dollars On Medicines

Thursday 28th of November 2013
An IMS health study forecasts global spending on medicines is to reach $1 trillion threshold in 2014.
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IU Clarified by EMA

Wednesday 27th of November 2013
The EMA clarifies the acceptability of the use of the abbreviation ‘IU’ in the EU Member States.
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EMA Publishes Draft Guideline on Using Urine Derivatives

Tuesday 26th of November 2013
A draft guideline on the adventitious agent safety of urine derived medicinal products has been published.
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CMDh announces end date of pilot phase for certain eCTD submissions

Monday 25th of November 2013
The pilot phase for the technical validation of eCTD submissions for new MAAs in a DCP will end on the 31st December 2013.
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EMA Releases Second Draft Guideline for consultation

Thursday 21st of November 2013
The clinical investigation of medicinal products for the prevention of stroke and systemic embolic events in patients with non-valvular atrial fibrillation
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PRAC Meeting

Thursday 21st of November 2013
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 November 2013 has been published
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Pharmacokinetics Q & A Updated

Wednesday 20th of November 2013
The Q & A document that discusses specific questions addressed to the pharmacokinetics working party has been updated
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EMA's product specific guidance on bioequivalence for 16 substances

Tuesday 19th of November 2013
The EMA’s first product-specific guidance on the demonstration of bioequivalence for 16 active substances has been released
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Mitigating risk aversion in medicines regulation in the interest of public health

Tuesday 19th of November 2013
EMA staff discuss mitigating risk aversion in medicines regulation in the interest of public health
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Medicrime Convention held in Strasbourg

Friday 15th of November 2013
The Council of Europe steps up action against counterfeiting worldwide with the Medicrime Convention
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Patients see the Black Triangle on Patient Information Leaflets

Friday 15th of November 2013
Patients start to see the black triangle in the Patient Information Leaflet for relevant medicines for the first time.
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MHRA Responds to EMA Combined Hormonal Contraceptives Review

Wednesday 13th of November 2013
The MHRA has responded to the EMA recommendation following a review on combined hormonal contraceptives
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EC GMP Public Consultations Responces

Tuesday 12th of November 2013
Responses to a number of EC GMP public consultations are now available
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EMA Publishes Addendum on Guildline for the Treatment of Bacterial Infections

Monday 11th of November 2013
The EMA has published an addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections.
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EC seeking comments on the Paediatric Investigation Plan Guideline

Friday 8th of November 2013
Revision of the paediatric investigation plan guideline: stakeholder comments sought by the European Commission
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EMA publishes concept paper on guideline for the treatment of Alzheimer's

Thursday 7th of November 2013
The EMA has published a concept paper for consultation on the need to revise the guideline on medicinal products for the treatment of Alzheimer's disease and other dementias
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Amendments to the Pharmacovigilance Legislation

Thursday 7th of November 2013
New notification requirements for marketing-authorisation holders and changes to scope of European safety referrals are now in force
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'-omics' technologies in the development of personalised medicines

Thursday 7th of November 2013
An EC working document has been published on the use of '-omics' technologies in the development of personalised medicines
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Updated Guide on Worksharing Variations

Monday 4th of November 2013
The CMDh has revised its best practice guide on worksharing variations
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September Pharmacovigilance Risk Assessment Committee Meeting

Friday 1st of November 2013
The latest situation on the use of Hydroxyethyl starch (HES) solutions for infusion is detailed in the minutes of the September PRAC meeting
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EMA updates dossier on CAPs

Thursday 31st of October 2013
The dossier requirements for centrally authorised products (CAPs) has been updated
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Why releasing clinical-trail data is beneficial

Monday 28th of October 2013
The EMA explain why access to full clinical-trial data sets will benefit medicine developers
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New document for Manufacturing Specials

Friday 25th of October 2013
The MHRA has developed a new guidance document for Manufacturing Specials (MS) to ensure consistency during routine GMP inspections.
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Blue Box Label Update

Thursday 24th of October 2013
‘Blue box’ labelling requirements have been updated for the second time this year
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Consultation on the risk of antimicrobial resistance

Wednesday 23rd of October 2013
A Reflection paper has been released for consultation on the risk of antimicrobial resistance transfer from companion animals
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First qualification opinion on a statistical methodology for dose finding released

Tuesday 22nd of October 2013
The European Medicines Agency wants to know the best dose of a new medicine during the clinical development programme.
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EMA wants type-I variations submitted by November

Monday 21st of October 2013
EMA encourages companies to submit quality type-I variations for 2013 by end of November
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Interchangeable Medicines

Friday 18th of October 2013
The latest IMB newsletter gives additional information on interchangeable medicines
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Electronic Submission Roadmap announced

Thursday 17th of October 2013
eSubmission Roadmap attempts to address current problems associated with eSubmissions in the EU
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The Irish Medicines Board Freezes Fees

Wednesday 16th of October 2013
The IMB will not increase fees in 2014
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Public will see clinical trial results

Wednesday 16th of October 2013
Summary results of clinical trials are soon to be available to the public
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A public consultation opened on proposed amendments to the current guideline on paediatric investigation plans

Wednesday 16th of October 2013
European Medicines Agency and its Paediatric Committee will be making amendments to the September 2008 guidlines.
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Appeal to block generic Nexium unsuccessful

Wednesday 18th of September 2013
AstraZeneca is unable to block generic Nexium during the on-going US Appeal Process
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E-Cigarettes as effective as patches

Tuesday 17th of September 2013
Studies show e-cigarettes are as effective as nicotine patches when helping smokers quit
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EMA Guidance on Inspection of a Bioequivalence Trial

Monday 16th of September 2013
The EMA has published a guidance for assessors on factors that can trigger an inspection of a bioequivalence trial.
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Payment of Fees by Non-Residents

Wednesday 11th of September 2013
Instructions on payments of fees to the Spanish Agency of Medicines and Medical Devices by non-residents in Spain
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News from PRAC September 2013 Meeting

Tuesday 10th of September 2013
The Pharmacovigilance Risk Assessment Committee (PRAC) gave recommendations on two medicines and started one new safety review at its September 2013 meeting.
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Gilenya causes serious brain infection

Friday 6th of September 2013
The FDA has issued a public alert for Gilenya after a serious brain infection was observed in an EU patient
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ABPI Guidlines Published

Wednesday 4th of September 2013
New ABPI guidelines have been published on clinical trial disclosure and transparency issues
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Additional Information on Generic and Interchangeable Medicines

Tuesday 3rd of September 2013
The IMB has published additional information on its list of generic & interchangeable medicines
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Falsified Medicines Directive Transposed

Friday 30th of August 2013
The Falsified Medicines Directive has now been moved into UK legislation
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Fee waiver for PV-related variations

Tuesday 6th of August 2013
A full waiver of fees for certain pharmacovigilance-related Type-IAIN variations has been announced by the EMA
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Revision of GLP Quality Assurance

Monday 5th of August 2013
The MHRA GLP guidance document on the content of GLP quality assurance statements has been revised
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Guidline on medicines for treatment of IBS

Thursday 1st of August 2013
The EMA has released a guideline on medicines for the treatment of irritable bowel syndrome for a six-month public consultation
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PRAC celebrates its first year of operation

Wednesday 31st of July 2013
Pharmacovigilance Risk Assessment Committee celebrates its first year of operation
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EU Falsified Medicines Directive

Friday 12th of July 2013
EU falsified medicines directive: from 2nd July ex EU imported active substances now need written confirmation to guarantee GMP standards
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EMA Guidline - Treatment of Asthma

Monday 8th of July 2013
Comments are invited on the EMA guideline clinical investigation of medicines for the treatment of asthma
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Q&As from GPvP Symposium published

Friday 5th of July 2013
Q&As from the GPvP Symposium 2013 have been published by the MHRA
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EMA fees for PV proposal accepted

Thursday 4th of July 2013
The legal proposal for EMA fees for pharmacovigilance has now been adopted
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The first two monoclonal antibody biosimilars have been approved by the EMA

Wednesday 3rd of July 2013
European Medicines Agency recommends approval of first two monoclonal antibody biosimilars
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Croatia joins European Medicines Network

Tuesday 2nd of July 2013
Croatia becomes a new member of the European medicines network
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US has Equivalent Standards to EU

Wednesday 26th of June 2013
The US has been added to the "list of third countries" having standards of manufacture and supervision of active pharmaceutical ingredients equivalent to those in the EU
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New PRAC Recommendations

Monday 17th of June 2013
PRAC makes safety referral recommendations for codeine, diclofenac, hydroxyethyl-starch-containing solution for infusion and flupirtine-containing medicines
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E-cigarettes face new restrictions

Thursday 13th of June 2013
Electronic cigarettes will be licensed as a medicine in the UK from 2016, under new restrictions recommended by the medicines regulator. CambReg can help you get your licence in a timely and cost effective manner. Contact us for details.
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New Guidline on Biosimilars

Monday 10th of June 2013
EMA publishes new draft guideline on biosimilars: non-clinical and clinical issues.
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EU Clinical Data Transparency

Wednesday 5th of June 2013
EU clinical data transparency one step closer as draft regulations approved
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Clinical Development for Medicinal Products

Monday 3rd of June 2013
The EMA has published the draft guideline on the clinical development of medicinal products intended for the treatment of pain
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e submissions via the CP

Tuesday 28th of May 2013
The eSubmission Gateway or web client is to become mandatory from March 2014 for all eCTD centralised procedure submissions
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Paediatrics

Wednesday 22nd of May 2013
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Processing of fee reductions for orphan medicines has been simplified by the EMA

Wednesday 15th of May 2013
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The Irish Medicines Board is now accepting requests for Ireland to act as RMS

Monday 13th of May 2013
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The EMA has published a new draft guideline on similar biological medicinal products

Wednesday 8th of May 2013
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Good Pharmacovigilance Practices

Friday 3rd of May 2013
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MHRA - FAQ on Patient Specific Directions

Thursday 25th of April 2013
FAQ on Patient Specific Directions
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IMB joint labelling

Thursday 25th of April 2013
The IMB has published a paper clarifying the procedure for dealing with joint labelling between the UK and IE following completion of an EU procedure
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UK National Apprenticeship Week 2013

Monday 11th of March 2013
Cambridge Regulatory Services supports UK National Apprenticeship Week 2013
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The revamped EudraGMP database may make GMP noncompliance statements public

Friday 8th of February 2013
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The CMDh has updated its guidance on the classification of unforeseen variations (‘Article 5’ recommendations

Friday 8th of February 2013
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Minutes have been published of a meeting between the CMDh and Interested Parties on DCP/MRP improvements

Thursday 7th of February 2013
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The EMA has published a guideline on the non-clinical and clinical development of similar biological medicinal products containing low-molecular-weight heparins

Wednesday 6th of February 2013
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The EMA has the updated the table template that accompanies the cover letter in MAA submissions made via the Centralised Procedure

Thursday 31st of January 2013
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The EC has launched a public consultation on the proposed revisions to the EU GMP guidelines

Wednesday 23rd of January 2013
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The MHRA has updated information on the transfer of existing herbal product licences to the traditional herbal registration scheme

Tuesday 22nd of January 2013
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Concept paper on the need for a paediatric addendum to the guideline on clinical investigation of medicinal products for the treatment of acute heart failure

Monday 21st of January 2013
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S10 Guidance on the photosafety evaluation of pharmaceuticals has been published by the ICH

Thursday 17th of January 2013
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The EMA has issued a draft guideline on pharmaceutical development of medicines for paediatric use

Tuesday 15th of January 2013
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The MHRA is to cease sending any email correspondence to advise regarding invalidated PLPI submissions.

Tuesday 15th of January 2013
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The EMA draft guideline on setting health based exposure limits will impact on the manufacture of different medicinal products in shared facilities

Monday 14th of January 2013
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The EMA’s eSubmission web client for electronic submissions is now available for registration

Thursday 10th of January 2013
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Implementation of the variation regulation

Thursday 1st of November 2012
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EMA reporting requirements of ICSR's during interim period

Monday 15th of October 2012
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EMA list of reference dates and frequency of submission of PSUR's

Thursday 11th of October 2012
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EMA to accept biosimilar reference medicines sourced outside EU

Thursday 4th of October 2012
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Public consultation paper - Paediatrics

Thursday 27th of September 2012
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Revised guidelines on GMP

Wednesday 12th of September 2012
Eudralex has published three revised guidelines for good manufacturing practice:
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User Tests at £2,500*

Thursday 3rd of May 2012
User Tests at £2,500* are being offered by CambReg throughout the months of May and June. Due to a postponement of a major project, CambReg’s UT Team will be able to dedicate time to your project instead, at a bargain rate, for this short period of time. The work will of course be carried out to the same high standards that CambReg are known for; high success rates and fast turnaround times.
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eSubmission Gateway now live for all applications for human medicines to the European Medicines Agency

Thursday 3rd of May 2012
The European Medicines Agency’s eSubmission Gateway is now live for all applications for centralised marketing authorisations for human medicines. The eSubmission Gateway is an electronic submission channel that allows applicants to submit documents supporting all types of applications for human medicines to the Agency securely over the internet in the eCTD format
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