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

Comments related to this concept paper should be provided using this template. The completed comments form should be sent to BWPSecretariat@ema.europa.eu .

Please note that the deadline for comments for this concept paper is 31 August 2011.

We would be grateful if you could disseminate this email to anyone else who might be interested in this document.

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.

April 2011 issue

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