News

The IPRP BEWGG is pleased to share an updated assessment report template for Biopharmaceutics Classification System (BCS) biowaivers in accordance with the ICH M9 guideline. Furthermore, a first

The fourteenth meeting of the Management Committee (MC) of the International Pharmaceutical Regulators Programme (IPRP) was held on the 6th and 7th of November 2024 in Montreal, Canada.  32 IPRP

The IPRP is pleased to share a Good Reliance Practices Repository. The document gives information on some reliance examples, considering different regulatory functions, technical scope,

The thirteenth meeting of the Management Committee (MC) of the International Pharmaceutical Regulators Programme (IPRP) was held on the 5th and 6th of June 2024 in Fukuoka, Japan. 29 IPRP Members and

The twelfth meeting of the Management Committee (MC) of the International Pharmaceutical Regulators Programme (IPRP) was held on the 1st and 2nd of November 2023 Prague, Czech Republic. 29 IPRP

The IPRP Biosimilars Working Group (BWG) is hosting a virtual workshop "Increasing the Efficiency of Biosimilar Development Programs-Reevaluating the Need for Comparative Clinical Efficacy Studies" on

The IPRP is pleased to share an updated Questions and Answers document on key aspects for reliance, that was revised by the IPRP Reliance Discussion Group to clarify the question on sameness of

The eleventh meeting of the Management Committee (MC) of the International Pharmaceutical Regulators Programme (IPRP) was held on the 13th and 14th June 2023 in Vancouver, Canada. 23 IPRP Members and

The IPRP Cell Therapy Working Group (CTWG) and Gene Therapy Working Group (GTWG) have developed the Reflection Paper on General Considerations for Raw Materials Used in the Manufacture of Human Cell

The tenth meeting of the Management Committee (MC) of the International Pharmaceutical Regulators Programme (IPRP) was held on the 16th and 17th of November 2022, Incheon, Republic of Korea.