Public Summary/Public Statement
The International Pharmaceutical Regulators Forum (IPRF)
Endorses a Long-Term Strategic Approach
Osaka, Japan, December 2016
The Management Committee (MC) of the International Pharmaceutical Regulators Forum (IPRF) met in Osaka, Japan, November 6-7, 2016. During this meeting, the MC endorsed elements for a long-term strategic approach for its future work.
Recognizing that the IPRF promotes regulatory convergence/harmonization and provides a unique platform for reliance and networking of members by fostering trust and a mutual understanding of the range of challenges and contexts facing each regulatory authority, work continued on developing a strategic vision for the initiative. Discussions over the past year have now culminated in the endorsement of mission and vision statements, as well as strategic objectives. Specific measures to achieve those objectives are well-advanced, with finalization anticipated in early 2017. Strategic objectives include: supporting an increased level of cooperation between members; maximizing the value and impact of IPRF by broadening awareness of its work; ensuring that the scope of IPRF activities fosters synergies and does not duplicate the efforts of other initiatives; and assuring the sustainability of the IPRF over time while improving its operations. The MC is working on incorporating these principles into a document that, once finalized, will be posted on the IPRF website.
Joan Blair (USFDA) and Patricia Pereira Tagliari (ANVISA), the new IPRF Chair and Co-Chair, welcomed the group to the 7th IPRF meeting. The outgoing Chair, Co-Chair, and Secretariat, Petra Doerr (Swissmedic), Naoyuki Yasuda (PMDA), and Cordula Landgraf (Swissmedic), were congratulated and thanked for their efforts and successful leadership tenure.
The Management Committee endorsed a revised mandate for a working group to address the implementation of the Identification of a Medicinal Product (IDMP), a suite of ISO standards for data elements, formats and terminologies for the unique identification of and the exchange of information on medicines. Therefore a new IPRF working group will be formed over the coming weeks.
IPRF operates four working groups that reported on progress made and presented their accomplishments based on the deliverables of their work plans:
- The Biosimilars Working reported on current activities of the group which included PASIBs (Public Assessment Summary Information for Biosimilars) as an information sharing tool, work on an IPRF Reflections Paper on Extrapolation of Indications in Authorization of Biosimilar Products, and collaborating with WHO on the basics of analytical comparability of biosimilar mAb for regulatory reviewers.
- The Gene Therapy Working Group’s primary objective is to gain a common understanding of the regulatory framework including laws, regulations and available guidance as well as of the classification of gene therapy products in participating regions. Current activities of the group include discussions on the long-term follow-up of patients having received gene therapy products, and the completion of a Concept Paper on “Biodistribution” in order to draft and IPRF Reflections Paper.
- The Cell Therapy Working Group has been gathering information on the categorization of cell therapy products and the degree of regulatory oversight in the participating regions. The group is drafting a Concept Paper on “General Principles to Address the Nature and Duration of Follow-up of Subjects in Clinical Trials of Cell Therapy Products” in order to draft and IPRF Reflections Paper.
- The Nanomedicines Working Group provided their most recent work product – Mapping and exchange of requirements for nanomedicines/nanotechnology in drug product class specific guidance (e.g. liposomal formulations) for MC endorsement, which will be posted on the IPRF website.
The IPRF Management Committee received updates from the International Generic Drug Regulators Programme (IGDRP), the International Coalition of Medicines Regulatory Authorities (ICMRA), the WHO, as well as participating regulators and regional harmonization initiatives (RHIs) on new legislation, guidelines, and upcoming training/conferences.
The next meeting of the IPRF Management Committee will be held in May 2017 in Montreal, Canada.