IPRF and IGRP Merge to Become the International Pharmaceutical Regulators Programme
Posted 08 December 2017 | By
With an aim toward better exchanging information and avoiding duplication, the International Pharmaceutical Regulators Forum (IPRF) and International Generic Drug Regulators Programme (IGDRP) initiatives will merge as of the first of next year and be known as the International Pharmaceutical Regulators Programme (IPRP), according to notes from the IPRF's management committee meeting in Geneva on 12-13 November.
The first face-to-face meeting of IPRP's management committee will be held in June 2018 in Kobe City, Japan, to elaborate finalize the Terms of Reference and governance structure for the consolidated entity. Funding will be provided by some of the regulatory authorities and the International Council for Harmonisation (ICH) Secretariat will provide support services to IPRP beginning 1 January 2018, according to IPRF.
The groups say a new website will be developed and should be launched in the second quarter of 2018 to provide the new venue for communications on the activities and outputs of IPRP.
At the Geneva meeting, according to the release, IPRF's five working groups also reported on progress made and presented their accomplishments based on the deliverables of their work plans:
- "The Biosimilars Working Group activities include the publication of a scientific reflection paper for extrapolation of indications and training material for biosimilar comparability, regulatory information sharing and mapping, the promotion of use for the existing deliverables and the facilitation of a training program.
- The Identification of Medicinal Product (IDMP) Working Group reported on their current activities including the development of a return on investment analysis to be developed by the ACSS (Australia, Canada, Singapore, Switzerland) Consortium, the development and publication of IDMP web presence and the development of a Q&A document centred on implementation and the experiences of early adopters.
- The Gene Therapy Working Group reported on their activities including the development of a reflection Paper on 'Expectations for Biodistribution Assessment of Gene Therapy Products.'
- The Cell Therapy Working Group reported on their activities including the development of a reflection paper to address the nature and duration of follow-up for subjects of clinical trials using cell therapy products.
- The Nanomedicines Working Group reported on their current activities including the publication of a survey for the mapping and exchange of requirements for nanomedicine / nanotechnology in drug product class specific guidance (liposomal formulations) as well as a poster 'Mapping Nanomedicine Terminology in the Regulatory Landscape.'"