Final Reflection Paper on Expectations for Biodistribution Assessments for Gene Therapy Products

20. July 2018

Reflection Paper on Expectations for Biodistribution (BD) Assessments for Gene Therapy (GT) Products

Public Statement – 1st meeting of the IPRP

4. July 2018

The inaugural meeting of the International Pharmaceutical Regulators Programme (IPRP) Management Committe (MC) was held on June 2nd and 3rd 2018 in Kobe, Japan with the participation of 20 IPRP Members and Observers.

Consolidation to create synergies in international collaboration: IGDRP and IPRF become IPRP

7. February 2018

Back in 2016, discussions started about a possible consolidation of the two initiatives, the International Generic Drug Regulators Programme (IGDRP) and the International Pharmaceutical Regulators Forum (IPRF). Both initiatives had complementary objectives and a largely overlapping membership of regulatory authorities and organisations, but a different scope of products: IPRF focused on innovative pharmaceutical products and technologies, IGDRP focused on issues of interest relating to generic products. Bot…

The IPRF agrees on a path forward and a new name

8. December 2017

The new initiative will be named the International Pharmaceutical Regulators Programme (IPRP). IPRP will be officially launched on January 1, 2018 with the first face-to-face meeting of IPRP’s MC in June 2018 in Kobe City, Japan.

Final Reflection Paper on Extrapolation of Indications in Authorization of Biosimilar Products

6. November 2017

The IPRF Biosimilars Working Group is pleased to announce the publication of a Reflection Paper on Extrapolation of Indications in the Authorization of Biosimilar Products. This Reflection Paper outlines principles for National Regulatory Authorities (NRAs) that participate in the IPRF to consider when evaluating biosimilar products for authorization.

Nanomedicines Working Group, recent publications

11. September 2017

Summary of liposomal survey and terminology poster

The International Pharmaceutical Regulators Forum (IPRF) Agrees to a Proposal for consolidation of IPRF with the International Generic Drug Regulators Programme (IGDRP)

30. August 2017

The Management Committee (MC) of the International Pharmaceutical Regulators Forum (IPRF) met in Montreal, Canada, May 28-29, 2017. The IPRF Management Committee continued in-depth discussions on the future direction of the regulatory collaboration initiative. 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.

The IPRF endorses a long-term strategic approach

10. May 2017

The Management Committee (MC) of the International Pharmaceutical Regulators Forum (IPRF) met in Osaka, Japan, November 6-7, 2016. During this meeting, the MC endorsed elements for a long-term strategic approach for its future work.

IPRF progresses work on future strategy – Public Summary/Public Statement

28. October 2016

The Management Committee of the International Pharmaceutical Regulators Forum (IPRF) met in Lisbon, Portugal, June 12-13, 2016. It continued a strategy development process that had been initiated at the meeting in December 2015.

Draft Reflection Paper on Extrapolation of Indications in Authorization of Biosimilar Products

6. September 2016

The IPRF Biosimilars Working Group (IPRF BWG) has proposed the development of a Reflection Paper. The IPRF BWG suggests that the National Regulatory Agencies (NRAs) that participate in the IPRF consider the proposed principles in the Reflection Paper on the extrapolation of indication(s) in the authorization of biosimilar products (also known as follow-on biologics, subsequent entry biologics or similar biological medicinal products, etc.). Interested stakeholders are invited to provide feedback during a 2-…

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