European Directive 2001/83/EC relating to medicinal products for human use was revised by Directive 2004/27/EC (published in April 2004).
Pharma Legislation Updates
EU / Active pharmaceutical ingredients / New GMP mandatory
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....
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