The International Pharmaceutical Regulators Programme (IPRP) was established as a result of a consolidation of the International Pharmaceutical Regulators Forum (IPRF) and the International Generic Drug Regulators Programme (IGDRP).
The International Pharmaceutical Regulators Programme (IPRP) was established as a result of a consolidation of the International Pharmaceutical Regulators Forum (IPRF) and the International Generic Drug Regulators Programme (IGDRP).
The Regulators Forum, the predecessor to IPRF, was originally created in 2008 as a forum for the discussion and promotion of harmonisation among regulatory authorities and Regional Harmonisation Initiatives (RHIs). Over time, the Regulators Forum evolved to the point of needing a more formal structure, resulting in the creation of IPRF in 2013.
The purpose of the IPRF was to create an environment for its members to exchange information on issues of mutual interest and explore opportunities for regulatory cooperation pertaining to the regulation of pharmaceuticals for human use. This dedicated venue aimed to maximise efficiencies in addressing the increasingly complex global context of medicines regulation, facilitate the implementation of ICH and other internationally harmonised technical guidelines for pharmaceuticals for human use, and contribute to the coordination of a range of international efforts related to regulation of medicinal products for human use.
The International Generic Drug Regulators Pilot was launched in 2012, in response to a shared interest and commitment by a consortium of regulatory authorities and regulatory organisations to explore potential information and work sharing opportunities in the area of generic medicines. Following a successful three-year pilot (2012-2014) and continued interest in collaboration, the renamed International Generic Drug Regulators Programme was launched in 2015 and aimed to work towards regulatory convergence and cooperation in this area.
The IPRF and IGDRP initiatives had complementary objectives and a largely overlapping membership, but a different scope of products: IPRF focused on innovative pharmaceutical products and technologies, whereas IGDRP focused on regulatory issues specific to generic pharmaceutical products. Recognising that efficiencies could be gained and synergies be created, IPRF and IGDRP agreed to a consolidation of the two initiatives in 2017 and the IPRP was lauched on January 1st, 2018.