2nd Meeting of the International Generic Drug Regulators Programme, Seoul, 4-5 November 2015


The 2nd meeting of the International Generic Drug Regulators Programme (IGDRP) was held in Seoul, South Korea from 4-5 November 2015, with resolution of barriers to progress work-sharing and stakeholder engagement being a primary focus of the meeting.

The meeting was chaired jointly by the South Korean Ministry of Food and Drug Safety (MFDS) and Australia’s Therapeutic Goods Administration (TGA). It was attended by ANVISA, COFEPRIS, Health Canada, Health Sciences Authority (HSA), Medicines Control Council (MCC), Ministry of Health Labour and Welfare (MHLW), Pharmaceuticals and Medical Devices Agency (PMDA), Swissmedic, Taiwan Food and Drug Administration (TFDA), the European Union (EU) as well as the European Directorate for the Quality of Medicines and Healthcare (EDQM) and the World Health Organization (WHO).

Working Group meetings

The IGDRP Active Substance Master File (ASMF)/Drug Master File (DMF) and Biowaivers Working Groups met from 2-3 November 2015 to discuss on-going projects aimed at facilitating regulatory convergence and work-sharing.

The following three completed projects of the ASMF/DMF working group are to be published on the IGDRP website (http://www.igdrp.com/): the ASMF/DMF common application form; ASMF/DMF common quality assessment report template and the ASMF/DMF lexicon of quality terms. The ASMF/DMF working group is expanding its scope and including in its workplan the additional projects of developing a Stakeholder Engagement Strategy and a DMF database as a repository of technical and regulatory issues of interest.

The Biowaivers working group has completed the survey of BCS biowaiver, the initial survey on waivers for additional non-biostudy strengths and acceptability of Foreign Comparators. The Biowaivers working group intends to expand its scope to Bioequivalence. The regulatory Gap analysis led by ANVISA and the gap analysis on ASMF/DMF frameworks and procedures led by PMDA are expected to be published shortly.

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 continue to be submitted to the EU DCP and participating IGDRP members for the DCP pilot, with 12 different companies submitted applications, of which two have been finalised.

In addition, a number of expressions of interest have been received under the CP pilot. Agencies are now compiling a list of additional questions asked by their evaluators and comparing them to the EU reports to present at the next face-to-face meeting. 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.

Both pilots are open to all members of the IGDRP.

Updates from other international initiatives – International Coalition of Medicines Regulatory Authorities (ICMRA), International Pharmaceutical Regulators Forum (IPRF) and the Australia, Canada, Singapore, and Switzerland Consortium (ACSS) - were provided to the Steering Committee in support of the IGDRP continuing mission to promote collaboration and regulatory convergence in areas that are not covered by existing initiatives.

The IGDRP website continues to make key information available in the public domain for those who are interested in the IGDRP and its activities. Regulatory agencies interested in participating in the IGDRP as observers may send an expression of interest to the IGDRP Secretariat (IGDRPSecretariat@tga.gov.au).

The next meeting of the IGDRP is scheduled to take place in Strasbourg, France from 9-12 May 2016.