The Biosimilars Working Group (BWG) has published a Primer on Biosimilar-Related Regulatory Topics for Regulatory Reviewers.    The Primer provides a compilation of publicly available

The eighth meeting of the Management Committee (MC) of the International Pharmaceutical Regulators Programme (IPRP) was held on the 19th and 22nd of November 2021. 24 IPRP Members and

The IPRP Cell Therapy Working Group (CTWG) and Gene Therapy Working Group (GTWG) have developed the International Regulatory Frameworks for Cell and Gene Therapies. In this document

The IPRP Quality Working Group (QWG) has developed the IPRP Quality Assessment Report (QAR) – Full Dossier template for the assessment of technical information contained in Common Technical Document

The Management Committee (MC) of the International Pharmaceutical Regulators Programme (IPRP) held its seventh meeting on the 7th and 8th of June 2021. Representatives from 27 IPRP Members and

The Working Group on Biosimilars (BWG) has published a Training Manual for Regulatory Reviewers on The Basics of the Clinical Comparability Exercise for Biosimilar Monoclonal Antibodies.  

The Management Committee (MC) of the International Pharmaceutical Regulators Programme (IPRP) held its sixth meeting on the 19th and 20th of November 2020, with the participation of Representatives

The NWG is conducting a Survey on Regulatory Requirements and Research Needs for Liposome Products amongst stakeholders, including Regulatory Agencies and other non-Regulatory stakeholders. Answers

The Working Group on Identification of Medicinal Products (IDMP) has updated its Frequently Asked Questions (FAQ) document to address questions related to IDMP standards and help support their

The Management Committee (MC) of the International Pharmaceutical Regulators Programme (IPRP) held its fifth meeting on the 28th of May 2020. Representatives from 25 IPRP Members and Observers joined