3rd Meeting of the International Generic Drug Regulators Programme, Strasbourg, 9-12 May 2016


The 3rd meeting of the International Generic Drug Regulators Programme (IGDRP) was held in Strasbourg, France, from 9-12 May 2016, the primary focus of the meeting being the resolution of barriers to progressing work-sharing, stakeholder engagement and the future direction of IGDRP.

The Steering Committee meeting was chaired jointly by the European Directorate for the Quality of Medicines & HealthCare (EDQM) and the South Korean Ministry of Food and Drug Safety (MFDS). It was attended by the Agência Nacional de Vigilância Sanitária (ANVISA), Federal Commission for the Protection against Sanitary Risk (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), European Commission and European Coordination for Mutual recognition and Decentralised Procedure Group (EU), Therapeutic Goods Administration (TGA), U.S. Food and Drug Administration (US FDA) as well as the World Health Organization (WHO).

Meeting Highlights

The Steering Committee reviewed a draft Roadmap document prepared to guide the future direction of the IGDRP and to ensure a common understanding of current and future strategic priorities and objectives of this collaborative initiative. It is anticipated that a further developed document will be available by the last quarter of 2016.

The Generic Products Regulatory Gap Analysis on requirements and approaches of IGDRP members (led by ANVISA), and the Gap Analysis on ASMF/DMF frameworks and procedures (led by PMDA) have been finalised and are expected to be published shortly. Once published, access to the articles will be made available on the IGDRP website.
An update on the IGDRP EU Decentralised/Centralised Procedure Information sharing pilots was given. Information on the generic drug product applications was shared and reviewed.

Updates from other international initiatives, the International Pharmaceutical Regulators Forum (IPRF) and the ACSS (Australia, Canada, Singapore, and Switzerland) Consortium were provided to the Steering Committee in support of the IGDRP’s continuing mission.

Working Group meetings

The IGDRP Active Substance Master File (ASMF)/Drug Master File (DMF) and Biowaivers Working Groups met from 9-10 May 2016 to discuss on-going projects aimed at facilitating regulatory convergence and work-sharing.
The IGDRP Steering Committee endorsed the recommendation by the ASMF/DMF Working Group to expand its scope and to change its name to the Quality Working Group.  This change was requested in order to cover quality aspects related to applications for generic drug products, while continuing to focus on ASMFs/DMFs within current resources alignment. Working group members provided important updates on various regulatory initiatives and international activities, and the implementation of established tools was reviewed (Common submission form elements, Quality Assessment Report template). The current status of various projects and the path forward, including milestones, for each project was discussed and agreed upon. Discussions regarding the scope and the development of an information work-sharing platform are on-going.

The IGDRP Steering Committee endorsed the recommendation by the Biowaivers Working Group to expand its scope and to change its name to the Bioequivalence Working Group within current resources alignment. This change was requested in order to cover issues related to the assessment of bioequivalence for generic drug products while continuing to focus on biowaivers. Working group members provided updates on the ongoing projects: publication of the survey of BCS biowaiver requirements; documentation necessary to support a request for a BCS biowaiver; tracking of new BCS classification decisions; biowaivers for additional non-biostudy strengths; acceptability of a foreign comparator; and biowaivers for additional dosage forms. The current status and path forward, including milestones, for each project was discussed and agreed upon.

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 actively in the IGDRP activities 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 Mexico City from 17-20 October 2016.