IPRF agrees on a path forward and a new name – the International Pharmaceutical Regulators Programme (IPRP) – for the consolidation of its operations with the IGDRP

The Management Committee (MC) of the International Pharmaceutical Regulators Forum (IPRF) met in Geneva, Switzerland on November 12-13, 2017. Celia Lourenco (Chair, Health Canada), Bianca Zimon (Co-Chair, ANVISA), and Nick Orphanos (Secretariat, Health Canada) welcomed the group to the 9th IPRF MC meeting. The main focus of the IPRF MC meeting was a discussion on elements of the implementation plan for the consolidation of the IPRF and International Generic Drug Regulators Programme (IGDRP) initiatives.

Consolidation of the IPRF and IGDRP Initiatives

Leading up to the IPRF MC discussions, a draft Implementation Plan and related documents for the consolidation were developed by a joint IGDRP/IPRF Implementation Task Group. These documents were discussed at the face-to-face meeting and progress was made on the proposed Terms of Reference, a governance structure, operational elements and communications strategies to facilitate a smooth transition and operationalise the consolidated initiative.

The new initiative will be named the International Pharmaceutical Regulators Programme (IPRP). IPRP will be officially launched on January 1, 2018 with the first face-to-face meeting of IPRP's MC in June 2018 in Kobe City, Japan. The IPRP MC will work to elaborate a new strategic vision and finalise the Terms of Reference and governance structure for the consolidated entity. With funding provided by some of the regulatory authorities, the International Council for Harmonisation (ICH) Secretariat will provide support services to IPRP beginning on January 1, 2018.

IPRP is expected to create an environment for its members and observers to:

• exchange information on issues of mutual interest and enable cooperation amongst regulatory authorities and organisations,
• maximise synergies and avoid duplication of effort,
• create a regulatory hub for pharmaceuticals that covers all medicinal products, and
• enable closer linkages with other initiatives to simplify the numerous forms of international regulatory collaboration.

A new website will be developed and should be launched in the second quarter of 2018 to provide the new venue for communications on the activities and outputs of IPRP. Until such time that the new website will be operational, interested parties can continue to visit the websites of the two initiatives (www.i-p-r-f.org and www.igdrp.com).

Other Discussions of the IPRF MC

The IPRF MC discussed collaboration in the area of vaccines as a potential new topic and held a focussed discussion on regulators' actions to combat Antimicrobial Resistance (AMR).  Given the potential scope of the topic and level of maturity in many aspects of vaccines development and regulation, discussions will continue at the next meeting in Kobe.

Updates were provided on the activities of the International Coalition of Medicines Regulatory Authorities (ICMRA), the World Health Organization (WHO), and the Pan-American Health Organization (PAHO) Regulatory Exchange Platform. Participating regulators and Regional Harmonization Initiatives (RHIs) also provided regulatory updates, in particular with regards to new legislation, guidelines, and upcoming training and conferences.

IPRF currently operates five working groups that reported on progress made and presented their accomplishments based on the deliverables of their work plans:

• The Biosimilars Working Group activities include the publication of a scientific reflection paper for extrapolation of indications and training material for biosimilar comparability, regulatory information sharing and mapping, the promotion of use for the existing deliverables and the facilitation of a training program.
• The Identification of Medicinal Product (IDMP) Working Group reported on their current activities including the development of a return on investment analysis to be developed by the ACSS (Australia, Canada, Singapore, Switzerland) Consortium, the development and publication of IDMP web presence and the development of a Q&A document centred on implementation and the experiences of early adopters.
• The Gene Therapy Working Group reported on their activities including the development of a reflection Paper on "Expectations for Biodistribution Assessment of Gene Therapy Products".
• The Cell Therapy Working Group reported on their activities including the development of a reflection paper to address the nature and duration of follow-up for subjects of clinical trials using cell therapy products.
• The Nanomedicines Working Group reported on their current activities including the publication of a survey for the mapping and exchange of requirements for nanomedicine / nanotechnology in drug product class specific guidance (liposomal formulations) as well as a poster "Mapping Nanomedicine Terminology in the Regulatory Landscape".

Next Meeting

The first meeting of the IPRP Management Committee will be held on June 2-3, 2018 in Kobe City, Japan. For further information, please contact the IPRF Secretariat at nick.orphanos@canada.ca or IGDRPSecretariat@health.gov.au. Contact information about the new Secretariat of IPRP will be published following its launch in January 2018.