The International Generic Drug Regulators Programme (IGDRP) was formed following progression from its 3-year Pilot phase and continues to promote collaboration and convergence in generic drug regulatory programs in order to address the challenges posed by increasing workloads and complexity of scientific issues.
Following on from the 7th and last meeting of the International Generic Drug Regulators Pilot in Singapore (November 2014), members met in Pretoria, South Africa from 27- 28 May 2015. The meeting was chaired by the Medicines Control Council (MCC) of South Africa and attended by ANVISA, COFEPRIS, Health Canada,Health Sciences Authority, Ministry of Health Labour and Welfare, Ministry of Food and Drug Safety, Pharmaceuticals and Medical Devices Agency, Swissmedic, Taiwan Food and Drug Administration, the Therapeutic Goods Administration and the European Union (EU) as well as the European Directorate for the Quality of Medicines and Healthcare (EDQM) and the World Health Organization (WHO).
The East African Community Medicines Regulatory Harmonisation initiative (EAC- MRH) and ZAZIBONA, a Southern African group of agencies involved in similar regulatory harmonisation initiatives, were invited to share their experiences in work sharing.
Working Group side meetings
Preceding the IGDRP Steering Committee meeting, from 25-26 May 2015, the IGDRP Active Substance Master File (ASMF)/Drug Master File (DMF) and Biowaivers Working Groups met to discuss on-going projects aimed to facilitate regulatory convergence and work-sharing. Both working groups have completed several projects such as the ASMF/DMF common application form; ASMF/DMF common quality assessment report template; ASMF/DMF lexicon of quality terms; BCS Biowaiver assessment report and documentation to be submitted for BCS Biowaivers. The work done by the IGDRP working groups will not only be able to facilitate use of another agency’s assessment report during the review of a generic product application, but also enable agencies without a framework to be able to adopt and implement one with minimal resources.
The completed gap analysis surveys, which now include a regulatory gap analysis led by ANVISA, a gap analysis on ASMF/DMF frameworks and procedures led by PMDA and BCS-based Biowaivers led by WHO, enabled understanding of the similarities and differences amongst the IGDRP members. The results also serve as a bench-marking tool for agencies wishing to adopt new, or update current, regulatory requirements, to further facilitate regulatory convergence.
Update on Information sharing pilots
Responses have been positive since the July 2014 launch of the EU Decentralised Procedure (DCP) pilot and the January 2015 launch of the EU Centralised Procedure (CP) pilot. Dossiers have been submitted both to the EU DCP and the participating IGDRP members for this pilot and some of the procedures have already passed the first evaluation phase of the DCP. In addition a number of expressions of have been received under the CP pilot. Both pilots are open to all members of the IGDRP. While Health Canada, Taiwan FDA, TGA and Swissmedic are currently participating in the pilot, several other agencies have expressed their interest to take part in future.
Launch of IGDRP.com
Another major achievement of the meeting was the launch of this website IGDRP.com which will facilitate communication with external stakeholders. With this momentum, the IGDRP is looking forward to continue its effort to achieve its goals of promoting collaboration and regulatory convergence for generic drug registration.
Regulatory agencies interested in participating in the IGDRP as observers may send their expression of interest to the IGDRP Secretariat (IGDRPSecretariat@tga.gov.au).
The next meeting of the IGDRP is scheduled to take place in South Korea from 2 to 5 November 2015.