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Regulatory News
New regulations in 2005
9/8/2005
The new “Provisions on Drug Registration”
became effective on May 1, 2005, replacing the former “Provisions on Drug Registration (Interim)”. The new regulation now provides that the registration of imported drugs is valid for five years instead of formerly only three years, and the registration can be renewed upon expiration.
The 2005 edition of the Pharmacopoeia of China
became effective on July 1, 2005. The new edition of the Pharmacopoeia added a new section for biological products which is the first time in its history. Compared with the 2000 edition, this edition of the Pharmacopoeia added 525 new drug products, and revised standards of 975 already-listed drug products.
The new “Provisions for Registration of Health Food Products (Interim)”
will became effective on July 1, 2005. Under the regulation, registration of health food products will no longer be permanent, and will need to be renewed every five years.
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