International Pharmaceutical Regulators Programme (IPRP)

The global context of medicines regulation is becoming increasingly complex, requiring a constant evolution in regulatory sciences to adapt to the pace of change. The purpose of IPRP is to create an environment for its regulatory members and observers to exchange information on issues of mutual interest, enable cooperation and promote convergence of regulatory approaches for pharmaceutical medicinal products for human use. Through its Management Committee and various working groups, IPRP facilitates discussions on global regulatory issues and on emerging technologies. IPRP also provides a venue to support the implementation of ICH guidelines and other standards, and for inter-agency information sharing and collaboration.

IPRP was launched on 1 January 2018, as a way to consolidate the International Pharmaceutical Regulators Forum (IPRF) and the International Genetic Drug Regulators Programme (IGDRP) to create efficiencies and synergies. The first face-to-face IPRP meeting was held 2-3 June 2018 in Kobe, Japan. The second face-to-face IPRP meeting was held 11-12 November 2018 in Charlotte, NC, United States. The third meeting was held 2-3 June 2019 in Amsterdam, Netherlands. As of the third meeting, IPRP has 26 Members (including the TGA) and 2 Observers globally. The fourth meeting will be held 20-21 November 2019 in Singapore.

Focus Topics for discussion by IPRP include Reliance, the act by which one regulatory authority takes into account the work performed by another regulatory authority or trusted institution. IPRP is working closely with WHO on this topic. Another topic under consideration is Real World Evidence, with IPRP working closely with International Coalition of Medicines (ICMRA) to further this work.

The IPRP currently comprises of 8 Working Groups (WG), these are:

• Bioequivalence WG for Generics;
• Quality WG for Generics Biosimilars;
• Information WG Sharing for Generics;
• Cell Therapy;
• Gene Therapy;
• Identification of Medicinal Products; and
• Nanomedicines (TGA is co-chair).

Publications

• The Bioequivalence WG for Generics recently developed an article for publication on Differences and Commonalities amongst Requirements for Additional Strength Biowaivers for Immediate Release Solid Oral Dosage Forms, as well as releasing a template for Biowaiver Assessment Report for Additional Strength(s) of systemically Active Immediate Release Oral Dosage Form.
• The Identification of Medicinal Products WG has published a Frequently Asked Questions (FAQ) document to address questions related to IDMP standards.
• The Cell Therapy WG has released a reflection paper General Principles to Address the nature and Duration of Follow-up for Subjects of Clinical Trials Using Cell Therapy Products.

More information on the IPRP and the products of the Working Groups can be found at the IPRP website.