Members and Observers of the International Generic Drug Regulators Programme (IGDRP)participated in its 5th meeting which took place in Ottawa, Canada from June 5th-8th, 2017. Concurrent meetings of the IGDRP Quality Working Group (QWG) and the IGDRP Bioequivalence Working Group (BEWG) took place on June 5th-6th. The Steering Committee (SC) meeting took place on June 7th-8th and was chaired by Health Canada and co-chaired by the Federal Commission for the Protection against Sanitary Risk (COFEPRIS). These IGDRP meetings were followed by an external symposium on June 9th entitled “Regulatory Collaboration and Emerging Issues in Generic Medicines - IGDRP and other Initiatives Responding to Today’s Demands and Future Challenges” to provide updates to the pharmaceutical industry and other stakeholders.
The IGDRP meetings were attended by representatives from:
- Agência Nacional de Vigilância Sanitária (ANVISA);
- European Commission (EC) and European Co-ordination group for Mutual recognition and Decentralised procedures - human (CMDh);
- European Directorate for the Quality of Medicines and HealthCare (EDQM) (Observer);
- Federal Commission for the Protection against Sanitary Risk (COFEPRIS);
- Health Canada;
- Health Sciences Authority (HSA);
- Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA);
- Medicines Control Council (MCC);
- Ministry of Food and Drug Safety (MFDS);
- Ministry of Health, Labour and Welfare (MHLW) / Pharmaceuticals and Medical Devices Agency (PMDA);
- Swissmedic;
- Taiwan Food and Drug Administration (TFDA);
- Therapeutic Goods Administration (TGA);
- U.S. Food and Drug Administration (US FDA) (Observer); and
- World Health Organization (WHO) (Observer).
IGDRP Steering Committee (SC):
The SC heard a number of presentations on other international initiatives, including the Australia, Canada, Singapore, and Switzerland (ACSS) Consortium, the International Pharmaceutical Regulators Forum (IPRF), and on Europe’s Active Substance Master File (ASMF) Work Sharing project. Reports on recent regulatory developments were presented by the Taiwan Food and Drug Administration (TFDA) and the Therapeutic Goods Administration (TGA).
An update was provided to the SC by a Health Canada representative on IT enablers supporting the interoperability and regulatory cooperation with domestic and international partners. Details were discussed on the Identification of Medicinal Products (IDMP) data standards that are being developed and updates were shared on the implementation status in some of the jurisdictions (notably, within the European Union).
Representatives from the pharmaceutical industry were invited for the first time to present to the SC during an information exchange session. Representatives from the global and Canadian offices of a multi-national pharmaceutical company shared their experiences and insightful perspectives gained from the participation in various regulatory information sharing pilots.
Further discussions took place on information-sharing initiatives within IGDRP and there was support for the continuation of the Information Sharing Pilots with European Union's Decentralised and Centralised Procedures.
A report was provided to the SC on the progress of the IGDRP Measurement and Evaluation Framework. This project is intended to assess the success of the IGDRP initiatives against their intended objectives and strategic priorities as described in the IGDRP Roadmap to 2020.
Consolidation of the IPRF and IGDRP Initiatives
The IGDRP Steering Committee continued in-depth discussions on the future direction of the regulatory collaboration initiative and how to be best positioned to respond to the complex issues and challenges facing regulatory authorities and organisations. It is recognised that enabling effective regulatory collaboration and convergence requires regulatory programmes to make use of resources efficiently to deliver their respective mandates.
To this end, various governance models for the initiative were considered and their potential advantages and disadvantages evaluated. Following this review, the IPRF Management Committee and the IGDRP Steering Committee support the consolidation of the IPRF and IGDRP initiatives. Consolidation of these two regulatory collaborative initiatives is expected to realise several opportunities including, for example,
- enabling a shared vision for information exchange and regulatory cooperation;
- maximising synergies and avoiding duplication of effort;
- creating a regulatory hub for pharmaceuticals that covers all medicinal products, enabling closer linkages with initiatives to simplify the numerous forms of international regulatory collaboration;
- improving governance for the management committees and the technical working groups.
Significant progress has been achieved to enhance cooperation and information sharing amongst the regulatory authorities and organisations. Efforts will be made to maintain this momentum and build on the best practices of each of these initiatives.
The joint initiative will be operational in January 2018 with the aim to have the first face-to-face meeting of the consolidated management committee in June 2018.
The IGDRP SC endorsed the recommendations by the QWG to publish a revised Quality Assessment Report (QAR) template for the assessment of Active Substance Master Files (ASMFs)/Drug Master Files (DMFs) as well as a document describing common criteria for when a separate ASMF/DMF should be submitted to a regulatory authority/organisation. It was also agreed that the QWG would initiate a gap analysis on approaches and terminologies used amongst members for variations (e.g., post-approval changes) to ASMFs/DMFs.
During its meeting, the IGDRP QWG discussed the details of a database intended to host ASMF/DMF information, with a longer-term view of potentially being able to share Quality assessment reports. It was agreed that before the QWG starts sharing information, a survey would be launched in order to gather feedback from key Industry representatives with regards to the feasibility and considerations for such a project and any potential issues related to it.
The IGDRP QWG continued working on a number of other key topics, including a repository of technical issues of interest, which is intended to collect outcomes of technical discussions between members.
Bioequivalence Working Group (BEWG):
The BEWG continued work on several of the ongoing projects, notably: a summary article on Biopharmaceutics Classification System (BCS)-based biowaiver requirements; the tracking of new BCS classification decisions; biowaivers for additional non-biostudy strengths (including a draft publication of a summary of members’ requirements and an assessment template); a draft publication of the members’ requirements for acceptability of a foreign comparator product; biowaivers for other dosage forms (other than solid oral products); and approaches for the selection of an alternative comparator product (e.g., when the innovator product is no longer marketed).
The summary article on BCS-based biowaiver requirements was a particular focus of the discussions at this meeting. Participants also shared information on notable regulatory developments in their respective jurisdictions and discussed approaches and solutions to technical issues of interest.
Next meeting:
The next face-to-face meetings of the IGDRP Technical Working Groups and Steering Committee will take place October 30th – November 2nd, 2017 in Brasilia, Brazil hosted and chaired by ANVISA.