ARCHIVED - Notice to Stakeholders - Invitation to Participate in a Survey for Canadian Active Pharmaceutical Ingredients (API) Stakeholders

Contact Information

Health Products and Food Branch Inspectorate
Drug Good Manufacturing Practices Inspection Unit
Graham Spry Building,
250 Lanark Avenue
Address Locator #2007B
OTTAWA, Ontario  K1A 0K9

March 25, 2011

11-106114-242

To: Stakeholders

Re: Invitation to participate in a survey for Canadian stakeholders conducting any API activities with respect to drugs for human use

For a number of years, Health Canada has been working toward the implementation of regulatory requirements for the manufacture of APIs in Canada through the amendment of the  Food and Drug Regulations and the adoption of the  International Conference on Harmonization Q7 guideline (ICH Q7) - the internationally recognized guideline that was developed to provide internationally harmonized guidance regarding Good Manufacturing Practices (GMP) for APIs. The results from past Health Canada surveys and consultations, and communication received from stakeholders, support the need and desire for stronger regulations of APIs in Canada.

With the goal to learn more about the current Canadian API landscape and consequently develop an effective, transparent and consistent API inspection approach, Health Canada invites you to participate in the nation-wide "Active Pharmaceutical Ingredients Survey - Activities Conducted with Respect to Drugs for Human Use". Participation in this survey is voluntary, but your cooperation and input are critical to building a successful Canadian API inspection program. Requests for copies of the survey and any questions or comments should be addressed to api_questions_ipa@hc-sc.gc.ca or sent to the mailing address above. We encourage you to take the time to complete this survey and return it by May 9, 2011.

This survey is one of the methods being used to gather information about the API industry directly from stakeholders including domestic manufacturing activities and imports of foreign manufactured APIs. It is also an excellent way for stakeholders to send in their comments and obtain answers to their questions. Health Canada plans to compile and consolidate the results of the survey into a high level report, which will summarize the general trends of information received and no one company's information will be identifiable. The release date of this report will be dependant on the number of surveys received and amount of information provided.

All information provided and collected through this survey will be used for the purpose stated in the survey and by Health Canada only. All information is subject to the Government of Canada's  Privacy Act.

Yours truly,
Original signed by
Diana Dowthwaite
Director General