Industry and Agency Obligations - Canada and Australia Parallel Review Project

Date 2006-09-29

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Introduction
Industry Obligations

• Submission Requirements
• Sponsor Requirements

Agency Obligations

Introduction

The purpose of this document is to outline the general requirements from industry sponsors to ensure the success of the parallel review pilot project. It is intended that this information be used as the basis for discussion with potential sponsors. This document also makes a general statement on agency requirements.

Industry Obligations

Submission Requirements

• Category I application ( Australia) and a New Drug Submission for a biological medicine that meets the current Priority ReviewPolicy ( Canada). For more info:
  
  Canadian Guidance for Industry: Priority Review of Drug Submissions
  
  Australian Regulatory Guidelines for Prescription Medicines
  
  
• All aspects of the submission provided to the two regulatory agencies must meet published submission requirements. For more info:
  
  Canadian Guidelines for Preparation of Drug Submissions
  
  Australian Regulatory Guidelines for Prescription Medicines
  
  
• All aspects of the submission provided to the two regulatory agencies must be identical.
  
  
• Identical submissions to both BGTD and TGA must each include: Modules 2-5 and both versions of Module 1 and any regional information in Module 3 (ie. both jurisdictions to receive both their own and the other jurisdictions' versions).
  
  
• The submission must describe a single manufacturing process, including identical sites and procedures for manufacturing the drug substance and drug product.
  
  
• Common Technical Document (CTD).

Sponsor Requirements

• Provision of 4-6 weeks 'Notice' to BGTD and TGA of firm date of submission.
  
  
• Simultaneous filing of submission in both jurisdictions.
  
  
• Willingness to participate in a pre-submission meeting with both jurisdictions.
  
  
• Support of regulatory processes in both jurisdictions.
  
  
• Payment of fees and charges applicable in each jurisdiction.
  
  
• Provision of letters authorizing the BGTD and TGA to exchange submission data (including commercial-in-confidence information as applicable) and reviews.
  
  
• Provision of input to the BGTD and TGA on sponsor costs/benefits of this process, to feed into a pilot project evaluation.

Agency Obligations

• BGTD and TGA will carry out the review process in as timely a manner as possible and according to target review timeframes.
  
  
• BGTD and TGA will conduct their respective review processes in parallel, in a spirit of collaboration and information sharing between the two organizations. While this parallel process is intended to optimize learning and confidence-building across the two agencies, BGTD and TGA remain obligated to render their own individual review decisions, which may or may not be the same.
  
  
• BGTD and TGA will conduct evaluations of each parallel review undertaken, which will include input from and feedback to industry. Outcomes of these evaluations will serve to inform continuous improvement of the review processes in both jurisdictions and may serve as a foundation for other parallel review pilots and possible joint review pilots in the future.