Notice: Release of Final Good Guidance Practices Manual

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Contact: Policy Bureau Enquiries

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October 31, 2007

Our file number: 07-123702-356

Release of Final Good Guidance Practices Manual

The Therapeutic Products Directorate (TPD) and the Biologics and Genetic Therapies Directorate (BGTD) are pleased to announce the publication of the final Good Guidance Practices Manual. The Manual is a revised version of the draft published for consultation in August 2006.

Good Guidance Practices (GGP) are the definitions, procedures and practices for the development, issuance and use of the various documents that provide guidance to TPD and BGTD staff and stakeholders. The GGP initiative is an integral component of the Health Products and Food Branch’s Therapeutics Access Initiative and is aimed to help improve the consistency, predictability and efficiency of the review process.

The GGP Manual is divided into Chapters, as follows:

TPD/BGTD Frequently Asked Questions: Good Guidance Practices

• Chapter 1: Guiding Principles
• Chapter 2: Definitions
• Chapter 3: Roles and Responsibilities
• Chapter 4: Procedures
• Chapter 5: Templates
• Chapter 6: Style Guide
• Chapter 7: Lexicon

Chapters 6 and 7 are still in draft form and are not being published with this package. All other Chapters are attached in final form.

Comments received from the consultation on the draft version of the GGP Manual were reviewed and considered in the finalization of the documents. Detailed comments and Health Canada discussion and response are outlined in the attached document, entitled Summarised Comments and Recommendations from External Consultations.

Questions or concerns related to the GGP Manual should be directed to:

Bureau of Policy, Science and International Programs
Therapeutic Products Directorate
Holland Cross, Tower B, A.L. 3102C3
1600 Scott Street
Ottawa, ON K1A 0K9

Tel: 613-957-6451
Fax: 613-941-1812
E-mail: Policy_Bureau_Enquiries@hc-sc.gc.ca