Regulators from several APEC countries met in Taiwan in early November for the second workshop on Good Review Practices. This was an advanced workshop, following on from the initial meeting held in Taipei in October 2011. The workshop was jointly hosted by the Taiwanese FDA and the Center for Drug Evaluation, Chinese Taipei, and sponsored by APEC, as part of the Regulatory Harmonisation Steering Committee mandate to promote a strategic, effective and sustainable approach to harmonisation for medical products (drugs and devices). The approximately 120 attendees included representatives from regulatory agencies in Taiwan, Singapore, Thailand, Indonesia, Papua-New Guinea, Saudi Arabia, Peru, Mexico, Argentina, Chile and Brazil.
The GRP project aims to contribute ultimately to regulatory performance and interagency cooperation in the field of reviewing applications to market medical products, recognising that a review is a complex undertaking which forms the scientific basis for regulatory decisions, the consequences of which are highly significant. The idea is to provide those involved in the review and decision-making process with the best possible support and tools for ensuring consistent, science-based assessments that comply with legal requirements.
The advantages of GRP are seen to be:
- an enhanced review system;
- increased interaction between reviewers and industry;
- enabling more effective training of reviewers;
- minimizing the risk of critical omissions, and
- enhancing clarity regarding assessments and ultimate decisions.
The common elements of GRP include:
- principles, procedures and templates related to the review process, including its management, peer review, use of internal/external advisory committees and interactions with sponsors;
- orientation and training for staff and management linked to defined competencies; and
- information repositories.
GRP is seen to be part of the continual improvement process for a regulatory agency, and to feed into a Quality Management System for the regulatory functions of the agency.
The workshop sessions covered:
- Quality System for Reviewers
- Key Elements and Strategies of a Good Review
- Critical Thinking and Decision Making: Drugs and Devices
- Transparency and Interactions: With the Public, Industry/Other Stakeholders and Regulatory Authorities
Sessions were chaired and facilitated by staff and/or alumni from the US FDA, Health Canada, the EMA, the European Commission, the Japanese PMDA and MHLW, the Taiwanese FDA and the Center for Drug Evaluation, the Singaporean Health Sciences Authority, the Thai FDA and among others, your correspondent, stepping in in the absence of TGA staff. These presenters shared their experience with reviewing medical products and facilitated discussion on what is already occurring in the represented APEC countries, what is possible with existing resources and how to build on what is already in place, with the aim of fostering information exchange and increasing available resources for review.
This APEC initiative also ties in well with the work item on Regulated Product Submission in progress under the newly formed International Medical Device Regulators’ Forum (IMDRF). The RPS is a message standard that can be used for the electronic submission of product information between a company and a regulatory agency for the purpose of gaining market authorization. More information on this IMDRF work item can be found here.