News
Written Confirmations for export of Active Substances manufactured in the UK Post Brexit
18th June 2019
The MHRA have published new guidance today to assist manufacturers in the event that the \'no-deal Brexit\' scenario happens in October.
MHRA GDP Pilot Scheme - OBERA: Office Based Evaluation and Risk Assessment programme
26th April 2019
The Medicines and Healthcare products Regulatory Agency (MHRA) is trialling remote assessment of some distribution facilities which would impact holders of a Wholesale Dealer’s Licence (WDA(H)) whose main activities operate from a head office supplied from a number of ‘satellite’ facilities. For the companies selected, their satellite sites will be assessed remotely using information provided by the company in a standardised format.
Use eCTD for all regulatory activities in National Procedures (NP) by 1 January 2019
18th January 2019
MA applicants are reminded that following the revision of the European eSubmission roadmap, as of January 1, 2019, every file for the acquisition of a license to market a drug for human use must be submitted in eCTD format.
Revised guideline to assess risk of human medicines for the environment
4th December 2018
EMA has published a revision of its guideline on the environmental risk assessment (ERA) of human medicines for a six-month public consultation.
Submitting regulatory information on medical products if there’s no Brexit deal
25th September 2018
MHRA stakeholders are being informed of what they’ll need to do to continue to submit regulatory information to us in the unlikely event of a no-deal scenario.
Report from EMA - Industry survey on Brexit preparedness
13th July 2018
"This survey indicates that some companies need to step up efforts to ensure medicine supply in the EU.
Variations Required: Concomitant use of benzodiazepines / benzodiazepine like products and opioids
3rd May 2018
If you are the Marketing Authorisation Holder with existing MAs based on benzodiazepines/benzodiazepine like products and opioids, you may be required to submit additional variations in line with the recent CMDh advice.
MHRA's Guidance on GxP data integrity
28th March 2018
‘GXP’ Data Integrity Guidance and Definitions.
Brexit Update: Ireland and Denmark to drop fees for RMS transfer post-brexit
13th February 2018
In light of the pending withdrawal of the UK from the EU, the Irish and Danish regulators are willing to waive the fees for Regulatory procedure regarding Change of RMS.
An overview of the EU’s orphan designation programme - EMA Factsheet
2nd January 2018
The new factsheet published by European Medicines Agency in December last year explains what a rare disease is, how the EU programme works and what incentives are made available to developers.
EMA to relocate to Amsterdam, the Netherlands
20th November 2017
EMA to begin working immediately with Dutch government to ensure successful move by end of March 2019
EU-US mutual recognition of inspections of medicines manufacturers enters operational phase
1st November 2017
1 November 2017 marks the coming into operation of further aspects of the mutual recognition agreement between the European Union (EU) and the United States (US) to recognise inspections of manufacturing sites for human medicines conducted in their respec
Better labelling of excipients for safe use of medicines
16th October 2017
Updated annex to excipient guidelines has new safety advice for 15 excipients
MHRA's recently published guidance on human factors
19th September 2017
MHRA has produced guidance on the human factors aspects of design for medical devices including those in drug-device combination products.
EMA's Revised guideline on first-in-human clinical trials
9th August 2017
Guidance outlines strategies to identify and mitigate risks for trial participants
EMA's Pre-submission checklist for type II variation applications
11th July 2017
A new Guidance document is available for Marketing Authorisation Holders published by EMA to help improve the quality of variation and renewal applications.
EMA Regulatory Guidance for industry to prepare for the UK’s withdrawal from the EU
1st June 2017
The European Medicines Agency (EMA) and the European Commission have published guidance to help pharmaceutical companies to prepare for the United Kingdom's withdrawal from the European Union. The guidance relates to both human and veterinary medicines.
EMA Notice to marketing authorisation holders of centrally authorised medicinal products for human and veterinary use
3rd May 2017
EMA and the European Commission have published a notice to marketing authorisation holders of centrally authorised medicines intended to remind them of their legal obligations in preparation for Brexit.
Changes to MHRA payment of fees
31st March 2017
The Medicines and Healthcare products Regulatory Agency (MHRA) has announced that paying for medicines licences, clinical trials and clinical investigations is changing from 1 April.
New MedRegs blog
9th February 2017
MHRA has launched an official blog providing expert insight into the latest regulatory thinking and all aspects of medicines regulation.
Standards for biological medicines - understanding them and how they make a difference
13th January 2017
The quality of biological medicines is assured by biological standards held by the British Pharmacopoeia (BP) and the National Institute for Biological Standards and Control (NIBSC)
Notification of intent to import an unlicensed medicinal product
7th December 2016
MHRA has published notification form to confirm that the import of an unlicensed medicinal product is requested by a doctor or dentist and is for use by his patients on his direct responsibility.
Export medical devices: special rules
8th November 2016
Outside the EU, manufacturers may need a Certificate of Free Sale (CFS) to export medical devices.
EU-US collaboration to boost medicine development for rare diseases
28th September 2016
New working group will share information and best practices--The European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) have set up a new ‘cluster’ on rare diseases to share experiences and best practices on each other’s
Pharmacovigilance Inspection Metrics Report April 2015 - March 2016
6th September 2016
MHRA Good Pharmacovigilance Practice Inspection Metrics for 2015/16 have been published.
MHRA - Updated Statement On The Outcome of The Brexit Referendum
21st July 2016
On 15th of July 2016, MHRA has updated their statement on Brexit Referendum
Introduction of a 'regulatory contact point' for marketing authorisation holders
17th June 2016
The European Medicines Agency implemented a 'regulatory contact point' within the EudraVigilance registration database. The EMA implemented this feature in the week commencing on 13 June 2016.
Single, central platform now mandatory for all PSURs
10th June 2016
PSUR repository facilitates information exchange on the safety of human medicines authorised in the EU
CMDh Update For New Applications
15th April 2016
Mock-ups, specimens and samples required for New applications
EMA update
19th January 2016
Human medicines: highlights of 2015