Pharma Legislation Updates
Japan / New pharmaceutical affairs law
1
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.
The new PAL also provides the opportunity to deposit a Drug Master File for the new pharmaceutical ingredients or for those, not listed in the official Japanese Pharmacopoeias (JP and JPE).
