Results of Singapore meeting, 2-5 November 2014


Following on from its sixth meeting in May 2014 in Yilan, Taiwan, representatives from the regulatory authorities of Australia, Brazil, Canada, Chinese Taipei, Japan, the Republic of Korea, Singapore, South Africa, Switzerland as well as representatives from the European Directorate for the Quality of Medicines and Healthcare (EDQM), European Union and the World Health Organization met in Singapore. The meeting was co-chaired by the Health Sciences Authority of Singapore and the Taiwan Food and Drug Administration (TFDA).

At its onset, the Pilot was envisioned to be a 3-year pilot. And now, as this 7th Meeting in Singapore represents the end of the Pilot, members of the IGDRP Active Substance Master File (ASMF)/Drug Master File (DMF) and Biowaivers Working Groups as well as the IGDRP Steering Committee conducted a self-assessment of the progress made and self-reflected on the IGDRP as a whole and its future.

To date, common draft assessment report templates have been developed by both Working Groups for the assessment of ASMF/DMFs and BCS-based biowaivers. These common templates 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. These templates are currently being used by IGDRP agencies in order to gather feedback from the assessors to further refine the templates in preparation for implementation within the IGDRP agencies (as defined by the national regulatory framework).

Completed gap analysis surveys, which now includes 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 reference and/or bench-marking tool for agencies wishing to adopt new, or update current, regulatory requirements, which is moving towards regulatory convergence. It is envisioned that the results of these surveys will be made available publicly for the benefit of industry stakeholders that file applications to multiple jurisdictions.

The IGDRP has been collaborating with the EU in an information sharing pilot involving generic product applications submitted under the EU Decentralised Procedure (DCP). This pilot was launched in July 2014 with the circulation of an Expression of Interest to the industry. Responses have since been positive – dossiers have been submitted both to the EU DCP and the participating IGDRP members for this pilot. Information sharing is expected to start in the near future when the dossiers undergo evaluation under the EU DCP. Furthermore, in response to this pilot, collaboration between the IGDRP and the European Medicines Agency (EMA) has begun with expressed interest in information sharing involving generic product applications submitted under the EMA Centralised Procedure.

With this momentum, the IGDRP is looking forward to continue its effort to achieve its goals of promoting collaborating and regulatory convergence for generic drug registration.

The 8th meeting of the IGDRP is scheduled to take place in South Africa in May 2015.