The International Generic Drug Regulators Programme (IGDRP) and the International Pharmaceutical Regulators Forum (IPRF) have decided to combine their work into a joint initiative that is expected to start in January 2018.
In order to best respond to the complex issues and challenges faced by regulatory authorities and organisations, the IPRF management committee and the IGDRP steering committee showed their support for the consolidation of the IPRF and IGDRP initiatives.
As a result of the consolidation of these two regulatory collaborative initiatives, several opportunities have been discussed, 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 and,
- improving governance for the management committees and the technical working groups.
The IGDRP Steering Committee (SC) approved the recommendations by the Quality Working Group (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”.
The Bioequivalence Working Group (BEWG) continued work on several ongoing projects including: “a summary article on Biopharmaceutics Classification System (BCS)-based biowaiver requirements; the tracking of new BCS classification decisions; biowaivers for additional non-biostudy strengths; 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.”
The consolidated management committee aims to have its first face-to-face meeting in June 2018.