CambReg News

eSubmission Gateway now live for all applications for human medicines to the European Medicines Agency

cambreg08 — Mon, 30 Apr 2012 09:20:50 +0000

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. Companies wishing to use the Gateway need to have access to the Electronic Standards for the Transfer of Regulatory Information (ESTRI) Gateway.
Full details of how to register are available on the eSubmission Gateway web page. Applicants who have already registered and used the Gateway during the pilot can continue to submit applications without registering again.
Submissions on physical media (CD or DVD) continue to be accepted as an alternative method. However, applicants using the Gateway must not submit duplicate submissions with physical media.

User Tests at £2,500*

cambreg08 — Thu, 19 Apr 2012 10:35:25 +0000

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.

We can accommodate about 8 tests in this time frame so call now to book your test – on 01480 465755 to take advantage of this situation giving a win/win outcome..

Be quick – its first come first served!

(*plus panel fees of £240.)

EMA new fees

cambreg08 — Thu, 12 Apr 2012 15:54:38 +0000

Fees payable to the European Medicines Agency by applicants and marketing-authorisation holders are increasing by 3.1% on 1 April 2012.

Full details of the new fees levels are available in the revised fee regulation, its implementing rules and the corresponding explanatory note on fees, published by the EMEA.

These documents include the new fees for all types of procedure handled by the Agency for human and veterinary medicines, including marketing-authorisation applications, post-authorisation procedures, scientific advice and inspections.

All applications received at the Agency by 31 March 2012 will be charged at the current fee and reduction rates. Applications received after that date will be charged the adjusted fees.

For scientific advice and protocol assistance for human medicines, the cut-off point will be the date of validation of the request for advice. For annual fees, the anniversary date defines the applicable fee. Consequently, any anniversary on or after 1 April 2012 will attract the new increased fee.

MHRA – flexibilty in the submission format of labels and leaflets

cambreg08 — Fri, 06 Apr 2012 15:50:43 +0000

Following consultation with medicines trade associations and member companies the MHRA has announced some procedural changes concerning the requirement to submit full-colour mock-ups of labels and patient leaflets. For a summary of the changes and further guidance & examples concerning new MA applications as well as Type 1B & Type II variations download the new guidance document.

You can find the section/document here: http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&ssDocName=CON146893

Draft concept paper – revision of guideline on excipients in the label and product leaflet of medicinal products for human use

cambreg08 — Fri, 30 Mar 2012 08:53:52 +0000

The current guideline on Excipients in the Label and Package Leaflet of Medicinal Products for Human Use (CPMP/463/00) remains valid. However, since the last revision of the guideline in July 2003 several safety concerns regarding excipients have been identified which are not currently addressed in the guideline. Proper labelling is needed to ensure the safe use of medicinal products containing certain excipients of concern.
The main safety concerns identified regarding excipients which are not currently addressed in the guideline include the following issues:
1.
The paediatric population.
2.
Pregnant women
3.
The labelling of several excipients currently addresses only a limited number of routes of administrations.
4.
Additional excipients need to be added to the guideline to ensure consistency in the safety labelling of medicinal products.
5.
Incomplete information is currently provided on how warnings in the package leaflet should be addressed in the summary of product characteristics (SmPC) in accordance with Article 59 (1) of Directive 2001/83/EC.

The draft revised guideline is expected to be released for 6 month external consultation in 3Q 2013-1Q 2014. After the external consultation the final guideline is expected to be available within 6-12 months.

European Medicines Agency launches electronic application form pilot

cambreg08 — Fri, 23 Mar 2012 08:52:02 +0000

The European Medicines Agency has launched a pilot of electronic application forms for submissions of centralised marketing authorisation applications today.
The pilot, which runs for four months until mid-July 2012, allows pharmaceutical companies to apply for initial marketing authorisation applications for human medicines, and variation and renewal applications for human and veterinary medicines, using an interactive PDF form.
Full details on how to register are available in the electronic application forms pilot guidance

Draft reflection paper from EMEA

cambreg08 — Mon, 12 Mar 2012 11:03:04 +0000

The EMEA has issued a draft reflection paper on the use of starting materials and intermediates collected from different sources in the manufacture of biologocal medicinal products. It looks at the extent to which any variability in early manufacturing steps would be acceptable. The deadline for comments is 31st August 2012.

New Pharmacovigilance legislation; Article 57(2) requirements

cambreg08 — Thu, 08 Mar 2012 11:02:48 +0000

Information to marketing authorisation holders on the updated format for electronic submission of information on medicines.
One of the key deliverables of the new pharmacovigilance legislation relates to the submission by marketing authorisation holders of information about medicines to the Agency. The requirement is described in Article 57(2) of Regulation (EC) No 1235/2010.
On 5 March 2012, the Agency published an updated set of mandatory Article 57(2) requirements for the electronic submission of information on medicinal products for human use.
The document provides an introduction to the changes and a description of how the various documents related to Article 57(2) compliance fit together.

DCP slot booking

cambreg08 — Fri, 02 Mar 2012 10:56:01 +0000

The CMDh has issued information on national timeslot booking systems and recommendations for requests to act as RMS;http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Application_for_MA/DCP/CMDh_020_2009_Rev10_February12.pdf

It has also developed a common request form, which can be found at; http://www.hma.eu/219.html.

Data requests for MRP/DCP

cambreg08 — Wed, 29 Feb 2012 10:53:30 +0000

Data requested for Variations and/or Renewal Applications in the MRP/DCP which are not stated in the current EU legislation and/or in Volume 2B, Presentation and format of the dossier Common Technical Document(CTD) and/or in the EEA approved Guidelines/ Recommendation papers, have been published.

Member States who are not mentioned in the table do not request additional data

http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Variations/CMDh_197_2010_Rev1.pdf