Therapeutic Products Directorate Good Review Practices Project

What is the Good Review Practices (GRP) Project?

The Therapeutic Products Directorate's (TPD) Good Review Practices (GRP) project was launched in March 2004. The goal of GRP is to promote the timeliness, predictability, consistency, and high quality of reviews and review reports for medical devices, pharmaceuticals, disinfectants, and sanitizers with disinfectant claims. This is done through the development of review tools [for example (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).

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

What does the GRP team do?

The GRP team 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 and templates on the following topics are available from the GRP team at grp_bpe@hc-sc.gc.ca:

Comprehensive SOPs and Templates

• Orientation of new drug and device reviewers
• Developing scientific and regulatory training courses for medical device and pharmaceutical reviewers

Device Specific SOPs and Templates

• Investigational Testing Application Review template
• Device Evaluation Division Technical Screening SOP
• Reviewer Medical Device License Evaluation Report SOP
• Software Verification and Validation Reviewer's Manual
• Device Review Templates (Class III; Class IV; Devices; In Vitro Diagnostic Devices)
• Section 36 Memo Template

Drug Specific SOPs and Templates

• 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
• Manager memo template: Labelling recommendations on marketing authorization
• Preparing Safety and Efficacy Reports on submissions for marketing authorization
• Manager memo template: Safety and Efficacy recommendations on marketing authorization
• Preparing Safety and Efficacy Reports on advanced consideration of Notice of Compliance with Conditions (NOC/c) or Priority Review
• Manager memo template: Safety and Efficacy recommendations on advanced considerations
• Preparing Reports on Periodic Safety Update Reports (PSUR) for products authorized under the NOC/c Guidance
• Preparing Reports on Responses to Qualifying Notices