New EMEA Guideline on Blood and Blood Products

GMP News No. 688

GMP News
8 March 2006
 

New EMEA Guideline on Blood and Blood Products

 
At the end of January, the COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) published a new version of the GUIDELINE ON THE SCIENTIFIC DATA REQUIREMENTS FOR A PLASMA MASTER FILE (PMF).

A revision of the document had become necessary because several current commission directives had to be considered in its content. Some of these directives had come into force already in 2005 so that the industry should have begun with their implementation. Therefore, two directives that will come into force on 31 August 2006 should be mentioned especially. These are texts on  "traceability requirements and notification of serious adverse reactions and events" and "quality system for blood establishments". One of the reasons why they are of great interest is that they reflect the peculiarities of blood and blood products, which lie with the collection of the starting material. This renders a close co-operation between the blood and plasma donors and the pharmaceutical industry indispensable. Chapter 2.1 of the revised guideline, which includes several references to the new directives, deals with this fact.

Comments on the draft guideline can be handed in to EMEA until the end of April 2006.

Author:
Dr Ulrich Herber
on behalf of ECA

Source: EMEA Web page: http://www.emea.eu.int/pdfs/human/bwp/379403en.pdf

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