Early last month, the International Pharmaceutical Regulators Programme (IPRP) management committee - following the consolidation of the International Generic Drug Regulators Programme (IGDRP) and the International Pharmaceutical Regulators Forum (IPRF) - held its inaugural meeting in Kobe, Japan with the participation of 20 IPRP members and observers.
The first management committee meeting, according to a statement released Wednesday
on the meeting, focused on the operationalization of the IPRP through the finalization and adoption of the IPRP Terms of Reference (ToR).
“Other foundational elements such as the Strategic Vision, Standard Operating Procedure (SOP) for the MC [management committee] and Working Groups (WGs), and launch of the new IPRP website will be completed in the coming months. Several IPRP foundational documents will be published on the new website at: www.iprp.global (available shortly),” the statement said.
Reports from each of the 8 IPRP WGs discussed: Nanomedicines, biosimilars, gene therapy, cell therapy, Identification of Medicinal Product (IDMP) and quality for generics and bioequivalence for generics, as well as “Information Sharing for Generics for the sharing of the European Medicines Agency (EMA) review reports.”
The management committee endorsed a reflection paper on “Expectations for Biodistribution Assessments for Gene Therapy Products” that will shortly be published on the IPRP website.
Two other publications are expected to be submitted to the management committee for approval in the coming months: a reflection paper from the Cell Therapy WG on “General Principles to Address the Nature and
Duration of Follow-up for Subjects of Clinical Trials Using Cell Therapy Products”; and a survey conducted by the Bioequivalence WG for “Generics of the Regulatory Requirements for the Acceptance of Foreign Comparator Products” by participating regulators and organizations of the IPRP.
Serving a one-year term, Brazil’s drug regulator ANVISA and Health Canada were also elected as IPRP management committee chair and vice-chair, respectively.
The purpose of IPRP, which is comprised of pharmaceutical regulators and organizations responsible for regulating medicinal products or Regional Harmonisation Initiatives (RHIs), “is to create a venue for regulatory authorities and organizations to share information, discuss issues of common concern, discuss emerging scientific areas of relevance to drug development and regulation, and work towards regulatory convergence.”
The next IPRP management committee meeting will be held 11 to 12 November 2018 in Charlotte, North Carolina.