Therapeutic Products Directorate (TPD) Good Review Practices Initiative

What is the Good Review Practices (GRP) Initiative?

TPD’s Good Review Practices (GRP) initiative was launched in March 2004. Good Review Practices are documented best practices for any aspect related to the process, format, content, and management of a health product review. The goal of GRP is to promote the timeliness, predictability, consistency, transparency, clarity, efficiency, and high quality of the content and management of reviews and review reports for medical devices and prescription pharmaceuticals. This is done through the development of review tools (e.g. standard operating procedures, templates, and training) and the provision of scientific and regulatory information in print, in person, and online (e.g. reviewer orientation packages, monthly reviewer discussion sessions, and the GRP Intranet). To promote continuous improvement, all aspects of Good Review Practices should be evaluated and updated on an ongoing basis.

The GRP initiative is run by a unit consisting of a project manager and project officers in the Office of Planning, Performance, and Review Services (OPPRS). The GRP unit is assisted by a steering committee, which includes representatives from across TPD and observers from across the Health Products and Food Branch (HPFB).

What does the GRP unit do?

The GRP unit develops and maintains review standard operating procedures (SOPs) / templates and reviewer training courses, prepares reviewer orientation packages, delivers monthly discussion sessions on a variety of topics, maintains the GRP Intranet, and sends out regular health product news updates. It also supports other areas developing and maintaining review tools.

Where can I get more information?

SOPs on the following topics are available from the GRP unit at grp_bpe@hc-sc.gc.ca:

Comprehensive SOPs

• Orientation of new drug and device reviewers
• Developing scientific and regulatory training courses for medical device and pharmaceutical reviewers
• Developing and Implementing Standard Operating Procedures for Use in the Review of Medical Device and Pharmaceutical Applications and Submissions

Device Specific SOPs

• Device Evaluation Division Technical Screening
• Preparation of the Scientific Review Report for Investigational Testing Authorization
• Preparation of the Scientific Review Report for Medical Device Licence Application
• Preparing the Device Evaluation Division Licence Recommendation Memorandum
• MDB Application Requiring Cardio-Renal Division Review

Drug Specific SOPs

• Preparing Executive Summaries on submissions for marketing authorization
• Preparing Executive Summaries on responses to Qualifying Notices
• Preparing Labelling Reports on applications and submissions for marketing authorization
• Preparing Safety and Efficacy Reports on submissions for marketing authorization
• Preparing Safety and Efficacy Reports on advanced consideration of NOC/c or Priority Review
• Preparing Reports on Periodic Safety Update Reports (PSUR) for products authorized under the NOC/c Guidance
• Preparing Reports on Responses to Qualifying Notices
• Requesting, Conducting, and Responding to Toxicology Assessment Consults on Impurities and Residual Solvents
• Requesting, Recommending and Managing Changes to the Prescription Drug List
• Risk Management Plan Good Practices