Life Science Regulation in Europe

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Committee for Advanced Therapies adopts first classification recommendation for an advanced therapy medicinal product
The European Medicines Agency’s (EMEA) Committee for Advanced Therapies (CAT) has adopted its first scientific recommendation on classification of an advanced therapy medicinal product. Press Release

European Court of Justice judgment on the definition of a medicinal product to be considered as a reference medicinal product in the meaning of Article 10 of the Directive 2001/83/CE

In its judgment of 18 June 2009 in case C-527/07, the European Court of Justice ruled that Directive 2001/83/EC is to be interpreted as meaning that a medicinal product which falls outside the scope of Regulation No 726/2004, and the placing of which on the market in a Member State.. Link

ICH Topic E16 Genomic Biomarkers Related to Drug Response: Context, Structure and Format of Qualification Submissions. Step 3
Note for guidance on genomic biomarkers related to drug response: context, structure and format of qualification submissions. Document

New regulation on maximum residue limits published today in the Official Journal
The new Regulation laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004.. Link

ICH Topic Q8, Q9 and Q10 Note for guidance on Pharmaceutical Development Quality Risk Management
Pharmaceutical Quality System – step 5
This Questions and Answers document (Q&A) refers to the current working procedure of the ICH Q-IWG on implementing the guidelines of Q8, Q9 and Q10 which have been approved by the ICH Steering Committee.. Link

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