Pharma Legislation Updates

The National Security Agency of Medicines and Health Products (ANSM) was officially created
The publication of the decree concerning the governance of ANSM allows the implementation of one of the main measures on strengthening the safety of the drug and health products. This measure will be effective from 1 May 2012. The new agency replaces the French Food Safety Agency...
EU / Heavy metals and Elemental impurities, April 2012
The European Pharmacopoeia Commission adopted one general chapter on Metal catalysts or metal reagents residues (5.20) and one method for the Determination of metal catalysts or metal reagent residues (2.4.20); chapter 5.20 is a reproduction of the EMA guideline on the specification...
EU / Active pharmaceutical ingredients / New GMP mandatory
European Directive 2001/83/EC relating to medicinal products for human use was revised by Directive 2004/27/EC (published in April 2004).
Japan / New pharmaceutical affairs law
The Pharmaceutical Affairs Law (PAL) was revised and implemented in April 2005. The recognition of the ICH Q7A reference system means that this new PAL supports harmonisation of Japanese law with Good Manufacturing Practices already in existence in   the USA and Europe....