The Members of the International Generic Drug Regulators Programme (IGDRP) participated in its 4th meeting held in Mexico, from 17 to 20 October 2016. The Members focused primarily on the future direction for IGDRP.
The Steering Committee (SC) meeting was chaired jointly by the Federal Commission for the Protection against Sanitary Risk (COFEPRIS) and the European Directorate for the Quality of Medicines & HealthCare (EDQM). The meeting was also attended by representatives from:
- Agência Nacional de Vigilância Sanitária (ANVISA)
- European Commission (EC) and European Co-ordination group for Mutual recognition and Decentralised procedures - human (CMDh)
- Health Canada
- Health Sciences Authority (HSA)
- Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA)
- Ministry of Food and Drug Safety (MFDS)
- Ministry of Health, Labour and Welfare (MHLW) / Pharmaceuticals and Medical Devices Agency (PMDA)
- Swissmedic
- Taiwan Food and Drug Administration (TFDA)
- Therapeutic Goods Administration (TGA)
- U.S. Food and Drug Administration (US FDA)
- World Health Organization (WHO)
Meeting Highlights
The Steering Committee reviewed the IGDRP Roadmap to 2020 document and endorsed it for publication on the IGDRP website. The Roadmap provides the strategic vision to articulate and guide the future direction of the IGDRP. Members also initiated the development of a logic model to measure the success in achieving the goals and to evaluate the achievements of the strategic priorities set out in the Roadmap. The IGDRP continues to pursue its ambition to increase efficiency of review procedures and reduce regulatory burden without comprising the safety, efficacy, and quality of generic medicines. The Members committed to work openly and transparently with regulatory authorities, stakeholders and other international partners. The current status of various projects and the path forward, including milestones, for each project was discussed and agreed upon.
The Generic Products Regulatory Gap Analysis survey on requirements and approaches of IGDRP Members (led by ANVISA) was endorsed for publication on the IGDRP website.
Updates from other international initiatives, including the International Pharmaceutical Regulators Forum (IPRF) and the ACSS (Australia, Canada, Singapore, and Switzerland) Consortium, were provided to the Steering Committee. The Members discussed various options for the proposed future collaboration of IPRF and IGDRP. The IGDRP SC remains committed to continue to work on a sustainable solution that would support its overall objectives.
The SC also heard presentations from Mexico’s COFEPRIS and Colombia’s INVIMA on notable developments and strategies in the regulation of generic medicines.
The SC agreed to streamline the induction process for agencies wishing to join the IGDRP, including updating the Terms of Reference to provide greater clarity over the expectations and procedures for becoming an IGDRP Member or Observer.
The IGDRP website continues to make key information available in the public domain for those interested in the IGDRP and its activities.
The next meeting of the IGDRP is scheduled to take place in Ottawa, Canada from 5-8 June 2017.
Working Group Meetings
The IGDRP Quality Working Group (QWG) and Bioequivalence Working Group (BEWG) met concurrently from 17-18 October 2016 to discuss on-going projects and the general direction for the Working Groups as they work towards 2017.
Quality Working Group (QWG):
The IGDRP SC endorsed the recommendation by the QWG to make available an accessible version of the Quality Assessment Report (QAR) template and the Common ASMF/DMF Submission Form, on the IGDRP website to facilitate the use of these documents by non-IGDRP regulatory authorities. Working Group members provided important updates on the ongoing QWG projects: Guidance for Quality Assessors (Drug Substance) and common criteria for filing of a new ASMF/DMF. The Working Group also discussed the next steps for the development of the IT platform to host the IGDRP ASMF/DMF database. The members agreed to the creation of the Repository of Technical Issues of Interest (a dynamic repository to collect the outcomes of technical discussions from the member agencies).
Bioequivalence Working Group (BEWG):
The IGDRP Steering Committee also endorsed the recommendation by the BEWG to publish the BCS-based Biowaivers Assessment Report template on the IGDRP website as it would prove valuable for companies planning a submission with a BCS-based biowaiver. The BE Working Group members provided updates on the ongoing projects: Summary article on BCS-based biowaiver requirements; tracking of new BCS classification decisions; biowaivers for additional non-biostudy strengths; acceptability of a foreign comparator; biowaivers for other dosage forms and alternative comparator product policies (e.g., when the innovator is no longer marketed).
Mexico City,
Mexico