Public Summary/Public Statement

The International Pharmaceutical Regulators Forum (IPRF) Agrees to a Proposal for consolidation of IPRF with the International Generic Drug Regulators Programme (IGDRP)

Montreal, Canada, August 2017

The Management Committee (MC) of the International Pharmaceutical Regulators Forum (IPRF) met in Montreal, Canada, May 28-29, 2017.

Joan Blair (Chair, US FDA), Bianca Zimon (Co-Chair, ANVISA), and Michelle Limoli (Secretariat, US FDA) welcomed the group to the 8th IPRF meeting. One of the main accomplishments of the meeting was the discussion of, and agreement to, a proposal to consolidate IPRF with the International Generic Drug Regulators Programme (IGDRP).

Consolidation of the IPRF and IGDRP Initiatives

The IPRF Management Committee continued in-depth discussions on the future direction of the regulatory collaboration initiative and how to be best positioned to respond to the complex issues and challenges facing regulatory authorities and organisations. It is recognised that enabling effective regulatory collaboration and convergence requires regulatory programmes to make use of resources efficiently in order to deliver their respective mandates.

To this end, various governance models for the initiative were considered and their potential advantages and disadvantages evaluated.  Following this review, the IPRF Management Committee and the IGDRP Steering Committee support the consolidation of the IPRF and IGDRP initiatives. Consolidation of these two regulatory collaborative initiatives is expected to realise several opportunities including, for example,

  • enabling a shared vision for information exchange and regulatory cooperation;
  • maximising synergies and avoiding duplication of effort;
  • creating a regulatory hub for pharmaceuticals that covers all medicinal products, enabling closer linkages with initiatives to simplify the numerous forms of international regulatory collaboration;
  • improving governance for the management committees and the technical working groups.

Significant progress has been achieved to enhance cooperation and information sharing amongst the regulatory authorities and organisations. Efforts will be made to maintain this momentum and build on the best practices of each of these initiatives.

The joint initiative will be operational in January 2018 with the aim to have the first face-to-face meeting of the consolidated management committee in June 2018.


Other Accomplishments

The IPRF members continued to work towards regulatory convergence and sharing of information on a number of topics, as per the IPRF’s strategic vision that was approved in November 2016. Given the impending consolidation of IPRF with IGDRP, a revised joint strategic vision will be developed for the consolidated entity in the near future. 

The term in office of the IPRF Chair and Co-Chair is a one year period, and these positions were up for nomination in Montreal.  The IPRF MC thanked the US FDA and ANVISA for their valuable contribution over their term. Celia Lourenco (Health Canada) was endorsed as the new Chair following the closure of the Montreal meeting, with the Co-Chair position remaining with Bianca Zimon (ANVISA). Health Canada will resume secretariat services for the remainder of 2017. The International Council for Harmonisation (ICH) Assembly approved a proposal from the IPRF MC for the ICH Secretariat to provide support services to IPRF starting on January 1, 2018. The Secretariat support services will cover the needs of the future IPRF and IGDRP consolidated entity.

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 endorsement of a reflection paper on the extrapolation of indications, training material for biosimilar comparability, regulatory information sharing and mapping, the promotion of existing deliverables and the facilitation of a training program. It was endorsed that the MFDS continues its chairmanship and Health Canada takes over co-chairmanship for the next three years.

  • The Gene Therapy Working Group activities include the planning of an in person meeting to develop a reflection Paper on “Expectations for Biodistribution Assessment of Gene Therapy Products”, participation in the Global Regulatory Perspectives Workshop and presentations at the International Society for Cellular Therapy (ISCT) annual meeting as well as discussions around potential future projects.
  • The recently launched Identification of Medicinal Product (IDMP) Working Group reported on their current activities including the finalization of its mandate and development of its first work plan.  Some elements for consideration by the group include an IDMP Policy Paper developed by the ACSS (Australia, Canada, Singapore, Switzerland) Consortium, the WHO vision/position/perspective on IDMP, gathering of global regulators views on IDMP as well as current thinking on global implementation guides.
  • The Cell Therapy Working Group activities include 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 target for completion of the paper is May 2018.

  • The Nanomedicines Working Group activities include the publication of a survey completed in 2016 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”. A recent face to face meeting was held which focused on the development of its work plan for the next year. Work objectives include a number of information sharing initiatives among regulators.

The US FDA proposed “Vaccines” as a potential new topic for discussion at IPRF. Given the potential scope of the topic and level of maturity in many aspects of vaccines development and regulation, it was decided that the EMA and WHO will work together on elaborating a proposal for consideration at the IPRF MC.

Updates were also provided on the activities of the International Coalition of Medicines Regulatory Authorities (ICMRA), the World Health Organization (WHO), as well as participating regulators and Regional Harmonization Initiatives (RHIs), in particular with regards to new legislation, guidelines, and upcoming training or conferences. The updates provided by members send a strong signal of the changing regulatory environment globally, the similar challenges regulators face globally and the value a forum such as IPRF can play in regulatory convergence.

Next Meeting

The next meeting of the IPRF Management Committee will be held on 12-13 November 2017 in Geneva, Switzerland.
For further information, please contact the IPRF Secretariat at nick.orphanos@hc-sc.gc.ca