TOPRA News
CHMP work plans take account of patient involvement, new pharmacovigilance legislation and GCP issues.
The work of the CHMP in 2012 and beyond was discussed at the recent TOPRA/EMA joint meeting
DELEGATES HEAR UPDATE ON EMA PLANS FOR 2012
At the recent TOPRA joint meeting with EMA, Noel Wathion (EMA) highlighted the challenges for EMA in 2012- 2013 as it adapts to the changing environment. Budgetary cuts may lead to reprioritization and reallocation of resources in order to meet the challenge of implementation of the new Pharmacovigilance legislation. The need for more transparency in the wake of the Mediator case has resulted in EMA releasing more than 1 million pages of documents in response to requests.
PATIENT CONTRIBUTIONS TO and TRANSPARENCY OF BENEFIT-RISK DECISIONS DISCUSSED AT JOINT TOPRA/EMA MEETING
Fiona Reekie (Janssen Research& Development) and Xavier Luria Oller (EMA) chaired a session looking at how critical decisions are made on new medicines and the role of patients.
EMA Consultation: Draft concept paper on process validation of medicinal products containing biotechnology-derived proteins
The European Medicines Agency has recently released a draft concept paper on the need for a guideline on process validation of medicinal products containing biotechnology-derived proteins as active substance.
The document is available for consultation. here
Human Medicines Highlights - April 2011
This newsletter is addressed to patients, consumers and healthcare professionals' organisations and is intended to provide a monthly update on key information on human medicines produced and published by the European Medicines Agency.
The information contained in each issue has been selected based on recommendations from consulted patients, consumers and healthcare professionals and is not intended to comprise a full set of the Agency's information.
Samarind RMS to sponsor the 2011 TOPRA Innovation Award
TOPRA is pleased to announce that Samarind, a leading provider of software to the Regulatory Affairs profession, will sponsor the Innovation category of the 2011 Regulatory Affairs Awards.
Lynda Wight, TOPRA’s Executive Director expressed delight that a winner in the 2010 Awards has agreed to support the 2011 event, adding ‘these Awards celebrate the very best in the world of regulatory affairs and with the support of all our sponsors we have added two new categories this year’.
EU Clinical Trials Register goes live
The EU Clinical Trials Register was launched today by the European Medicines Agency (EMA).
The online register gives for the first time public access to information on interventional clinical trials for medicines authorised in the 27 EU Member States and Iceland, Liechtenstein and Norway. The database also allows the public to search for information on clinical trials authorised to be carried out outside the EU if these trials are part of a paediatric investigation plan.
European Medicines Agency Consultation: Concept paper on potency declaration / labelling for biological medicinal products which contain modified proteins as active substance
The European Medicines Agency has recently published a draft concept paper on potency declaration/labelling for biological medicinal products which contain modified proteins as active substance
This concept paper aims to provide the rationale for drafting a guidance document for potency assignment of modified proteins for which an International Standard exists or where a clinical recognised unit exists (without an International Standard established) for the non-modified product.
The document is available for consultation on the following webpage:
European Medicines Agency Consultation: draft concept paper on the revision of the guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues
The European Medicines Agency has recently published a draft "Concept paper on the revision of the guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues".
European Medicines Agency Consultation: Draft guideline on the warning on transmissible agents SmPCs and package leaflets for plasma-derived medicinal products
The European Medicines Agency has recently published a draft guideline providing standard texts for warning statements on transmissible agents to be included in summary of product characteristics (SmPCs) and package leaflets for plasma-derived medicinal products.
The original guideline (CPMP/BPWG/BWP/561/03) was adopted by CHMP in October 2003 and came into operation in May 2004. This revision affects only the introduction, where an update related to vCJD and an addition concerning albumin as excipient are now included.
The document is available for consultation on the following webpage:
