Regulatory News

EMA Consultation: Reflection paper on classification of advanced-therapy medicinal products

The European Medicines Agency has recently published a Reflection paper on classification of advanced-therapy medicinal products.

The aim of this reflection paper is to introduce the advanced-therapy medicinal product (ATMP) classification procedure by means of clarifying the legal basis for ATMP classification, providing clarification on the grounds applied for the classification of ATMPs, providing further clarification on the information to be submitted by applicants for the purpose of the ATMP classification and communicating the current status of discussions on some borderline cases and on selected areas where scientific knowledge is fast evolving or experience is limited.

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Human Medicines Highlights Newsletter - April 2012

This newsletter is addressed primarily to organisations representing patients,consumers and healthcare professionals. It provides a summary of key
information relating to medicines for human use published during the
previous month by the European Medicines Agency.

Information is selected based on recommendations from consulted patients,
consumers and healthcare professionals, and does not necessarily cover all
relevant information published by the Agency.

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Human Medicines Highlights Newsletter - March 2012

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.

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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

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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.

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