Back in 2016, discussions started about a possible consolidation of the two initiatives, the International Generic Drug Regulators Programme (IGDRP) and the International Pharmaceutical Regulators Forum (IPRF). Both initiatives had complementary objectives and a largely overlapping membership of regulatory authorities and organisations, but a different scope of products: IPRF focused on innovative pharmaceutical products and technologies, IGDRP focused on issues of interest relating to generic products. Both sides had agreed that by a consolidation of the two initiatives, efficiencies could be gained and synergies be created.
The International Pharmaceutical Regulators Programme (IPRP) was officially launched on 1 January 2018, following a decision of the governance bodies of IGDRP and IPRF in November 2017 (see public statements*). 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.
On 25 January 2018, the first telephone conference of the newly established IPRP Management Committee (MC) was held to kick-off the joint work and to discuss progress in the process of consolidation. 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 provides support services to IPRP.
In order to deal with the implications of this process, a joint IGDRP/PRF Implementation Task Group had already been created in September 2017, which developed an implementation plan covering aspects from Terms of Reference, governance structure, operational elements and communications strategies to facilitate a smooth transition and operationalise the consolidated initiative.
A new website will be created and should be launched under the domain name www.iprp.global by mid to end of June 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 previous initiatives (www.i-p-r-f.org and www.igdrp.com), which will continously be updated.
The first face-to-face meeting of the IPRP Management Committee will be held on June 2-3, 2018 in Kobe City, Japan.
For additional information, please contact IPRPsecretariat@ich.org (ICH Secretariat).
* References: