Regulatory News

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".

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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:

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Human Medicines Highlights: Issue 25 - February 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.

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European Medicines Agency public consultation on ethical and good clinical practice (GCP) aspects of clinical trials conducted in third countries

The European Medicines Agency has published a draft 'Reflection paper on ethical and GCP aspects of clinical trials of medicinal products for human use conducted in third countries and submitted in marketing authorisation applications to the EMA'.

The document is available on the following webpage:

http://www.ema.europa.eu/Inspections/docs/71239709en.pdf

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European Medicines Agency consultation: Guideline on Procedural advice on the Submission of Variations for Annual Update of Human Influenza Inactivated Vaccines Applications in the Centralised Procedure

The European Medicines Agency has published a Guideline on Procedural advice on the Submission of Variations for Annual Update of Human Influenza Inactivated Vaccines Applications in the Centralised Procedure (EMA/CHMP/BWP/99698/2007 Rev. 1).

The document is available on the following webpage:

http://www.ema.europa.eu/pdfs/human/bwp/9969807en.pdf

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