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-…

Public Assessment Summary Information for Biosimilar (PASIB) – final documents after consultation

18. August 2016

The IPRF Biosimilars Working Group (IPRF BWG) has proposed the development of a template to assist National Regulatory Authorities (NRA) in making available a summary of the review of biosimilar applications in their country in a common language (e.g. English).

Template for Public Assessment Summary Information for Biosimilar (PASIB)

9. March 2016

The IPRF Biosimilars Working Group (IPRF BWG) has proposed the development of a template to assist National Regulatory Authorities (NRA) in making available a summary of the review of biosimilar applications in their country in a common language. Interested stakeholders are invited to provide feedback during a 2-months consultation period.

Fourth meeting of the IPRF – Public Summary/Public Statement

9. June 2015

The Management Committee of the International Pharmaceutical Regulators Forum (IPRF) met in Fukuoka on 8 and 9 June 2015. It was the fourth meeting after its establishment in 2013. The IPRF Management Committee approved the mandate of the Nanomedicines Working Group, which had been developed following the decision of the Committee at the last meeting, to take the topic on board. The Biosimilars, Gene Therapy and Cell Therapy Working Groups, reported on progress made and presented their work plans.

Third IPRF meeting – Public Summary/Public Statement

11. November 2014

The Management Committee of the International Pharmaceutical Regulators Forum (IPRF) met in Lisbon on 10 and 11 November 2014. It took note of the work done by the Working Group on the General Principles for the Education and Training of GCP Inspectors, which had achieved its mandate and adopted a proposal to establish a new Working Group on nanomedicines. The Management Committee also stressed the need to increase transparency of the IPRF activities and will adopt corresponding measures.

Public Summary of the Second IPRF meeting held in Minneapolis, US

3. June 2014

The Management Committee of the International Pharmaceutical Regulators Forum (IPRF) met in Minneapolis, MN, US, on 2 and 3 June 2014. It was the second meeting of this group, following on the work from the first meeting in November 2013 in Osaka, Japan.