Notice: Draft Guidance for Industry - Identification, Qualification, and Control of Related Impurities in New Drugs

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Contact: BPS Enquiries

Notice

September 6, 2005

Our file number: 05-119540-524

Health Canada is announcing the removal of the draft Guidance for Industry Identification, Qualification, and Control of Related Impurities in New Drugs.

The ICH guidelines Impurities in New Drug Substances (Q3A) and Impurities in New Drug Products (Q3B) provide guidance on the identification, qualification, and control of impurities in new drug substances and new drug products. These ICH guidelines have been the subject of the ICH maintenance process and were finalized in 2002 and 2003, respectively, and subsequently adopted by Health Canada in 2003.

In 1999, Health Canada released the draft guidance document Identification, Qualification, and Control of Related Impurities in New Drugs for Stakeholder consultation. The purpose of this companion guidance document was to provide further guidance on recommendations regarding the identification, qualification, and control of related impurities in new drugs.

The need for this companion document no longer exists due to the updated ICH Q3A and Q3B guidelines. The recommendations that had previously been included in the 1999 draft guidance document have now been adequately addressed in the updated ICH guidelines. As such, the 1999 draft Guidance for Industry has been removed from the TPD Website.

Comments or questions on this Notice should be forwarded (preferably in electronic format) no later than December 1, 2005 to:

Gary Condran
Senior Scientific Advisor,
Bureau of Pharmaceutical Sciences,
Therapeutic Products Directorate, Health Canada
1st Floor, Room D-122, Finance Building, Tunney's Pasture
(Address locator: 0201D)
Ottawa, Ontario, K1A 0K9

Telephone: (613) 941-3192
Facsimile: (613) 957-3989
Email: gary_condran@hc-sc.gc.ca