Notice - Good Laboratory Practice (GLP) Recognition for Canadian Facilities: Reminder to schedule your inspection before the end of the transition period

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September 30, 2010

Notice

Our file number: 10-120878-738

On April 30, 2010, Health Canada released the finalized Guidance Document Non-Clinical Laboratory Study Data Supporting Drug Product Applications and Submissions: Adherence to Good Laboratory Practice to guide sponsors who submit non-clinical study data on Canada's GLP requirements. All non-clinical studies (domestic or foreign), as defined in the Guidance document and initiated after April 30, 2010 are expected to comply with the GLP guidance document requirements. Canadian facilities generating GLP studies are expected to have been assessed by the Standards Council of Canada (SCC), the OECD recognized Canadian Monitoring Authority.

Designated by Health Canada as the Monitoring Authority for GLP compliance of Canadian test facilities, the SCC is a federal Crown corporation that promotes efficient and effective standardization in Canada. In addition to recognizing GLP compliance which sponsors can use to support a Canadian drug application for market authorization, SCC also operates various accreditation programs including one for testing and calibration laboratories. The abovementioned Guidance document provides for a one-year transition period in order to allow sufficient time for Canadian facilities to fully complete the GLP recognition process.

Health Canada and the SCC are reminding sponsors that Canadian facilities generating nonclinical study data in support of submissions or applications involving pharmaceutical, radiopharmaceutical or biologic drugs for human use, should have applied for GLP recognition and been found to be compliant with GLP by the SCC before April 30, 2011 which marks the end of the one-year transition period.

Sponsors and facility management are encouraged to start the application process early so as to allow the SCC to allocate inspection resources efficiently and accommodate facilities in meeting the end of transition deadline.

Questions on the GLP recognition program should be directed to:

Rassoulou Diallo
GLP Coordinator
Standards Council of Canada
200-270 Albert Street
Ottawa, Ontario
K1P 6N7
Canada

Fax: (613) 569-7808
Email: info@scc.ca
Website: www.scc.ca