- Tous > Quality and Safety: Medicines > Quality Assurance
- Tous > Quality and Safety: Medicines > Regulatory Support
- Tous > WHO Prequalification of Medical Products > WHO-UNICEF-UN Project
- Mots-clés > drug regulatory authorities
- Mots-clés > generic drug policies
- Mots-clés > generic pharmaceutical markets
- Mots-clés > generics industry
- Mots-clés > International Generic Drug Regulators Pilot (IGDRP)
- Mots-clés > medicines regulation
- Mots-clés > medicines regulatory authority (MRA)
- Mots-clés > Multisource (Generic) Pharmaceutical Product
- Mots-clés > quality of generics
- Mots-clés > regulatory harmonization
(2014; 8 pages)
The pre-market review of generic medicines puts mounting pressures on health regulatory authorities around the world due to increasing workloads and risks associated with complex global supply chains. This has led a group of regulators to launch the International Generic Drug Regulators Pilot (IGDRP), aimed at regulatory convergence and cooperation. The three-year pilot entails a series of concrete measures to facilitate the timely authorization and availability of safe, effective and quality generic medicines.
Results of the pilot will inform decisions on establishing a more permanent information and work-sharing arrangement as part of broader international efforts related to regulation of medicines. The success of the initiative will require the support of industry as well as other stakeholders interested in promoting access to affordable, quality generic medicines.