Regulatory News

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.

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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

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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.

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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.

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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:

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