International Pharmaceutical Regulators Forum (IPRF)

News

06 September 2016
Draft Reflection Paper on Extrapolation of Indications in Authorization of Biosimilar Products – public consultation

18 August 2016
Public Assessment Summary Information for Biosimilar (PASIB) – final documents after consultation


Purpose

The purpose of the International Pharmaceutical Regulators Forum (IPRF) is to create an environment for pharmaceutical regulators to exchange of information on issues of mutual concern and regulatory cooperation.

This dedicated venue for global regulators will maximize potential efficiencies in addressing the increasingly complex global context of medicines regulation, will facilitate the implementation of ICH and other internationally harmonized technical guidelines for pharmaceuticals for human use and will contribute to the coordination of a range of international efforts related to regulation of medicines.

Goals

The International Pharmaceutical Regulators Forum provides members a unique opportunity to leverage the expert scientific knowledge, regulatory and operational experience, on-going technical harmonization work, and information access of other participating regulators. 

The first goal is to enable all parties to identify new approaches and specific best practices, and develop smart strategies for dealing with the challenges of a rapidly evolving globalized pharmaceutical industry. 

The second goal is to provide a global overview of the different regulatory developments at national and international level and enable open sharing of information and ideas among regulatory leaders with hands-on operational responsibilities. This information sharing will allow the forum participants to discuss issues at an actionable level of detail.

The third goal is to support international regulatory cooperation in areas which are not covered by existing initiatives.