International Generic Drug Regulators Outline Plans for Collaboration Through 2020
As further cross-border harmonization among pharmaceutical regulators takes shape, the International Generic Drug Regulators Programme (IGDRP) has laid out its priorities that will take the group through the next four years.
Strategic priorities for the consortium include establishing a framework for sharing assessment-related information between regulators, promoting convergence of technical and data requirements and increasing the alignment of administrative and regulatory assessment procedures and tools.
Background
The official launch of the three-year International Generic Drug Regulators Pilot in 2012 explored the potential information- and work-sharing opportunities around generic drugs. Following a successful pilot and with continued interest to collaborate, a group of regulators launched the renamed International Generic Drug Regulators Programme (IGDRP) in 2015.
Participating agencies and organizations include the US Food and Drug Administration (FDA), Health Canada, the European Medicines Agency (EMA), China Food and Drug Administration (CFDA), Japan’s Ministry of Health, Labour and Welfare, Mexico’s COFEPRIS and Brazil’s ANVISA, among others.
The IGDRP is currently working on several projects:
- Quality Working Group (formerly known as the active substance master file (ASMF)/drug master file (DMF) Working Group)
- Bioequivalence Working Group (formerly known as the Biowaivers Working Group)
- Information and Work Sharing projects
Strategic Priorities/Objectives
Moving forward, the IGDRP will look to further an ongoing pilot on information sharing between IGDRP members, as well as conduct surveys and develop reference materials summarizing the similarities and differences between the regulators on topics of interest, “with a view to identify areas of potential regulatory convergence or harmonisation for domestic guidelines.”
The group will also look to further develop tools/mechanisms to exchange assessment reports and other documents that may contain confidential business information (CBI) between regulators.
In addition, the development of databases to identify common ASMFs/DMFs and applications submitted to regulators to register generic medicines will be another objective.
The group of more advanced regulators will also try to help those with less scientific expertise by enabling capacity building activities (e.g., with a joint review of the quality or bioequivalence information in a generic application) to better understand the interpretation and application of regulatory procedures and commonly used guidance documents.
The performance and impact of the program will be assessed at periodic stages, the report from December says, and an IGDRP Logic Model and an IGDRP Results and Data Matrix have been developed to assist in evaluating the effectiveness of the program.