The Steering Committee (SC) of the International Generic Drug Regulators Programme (IGDRP) met in Brasilia, Brazil on November 1-2, 2017. The Chair, ANVISA and Co-Chair (Health Canada), together with Dr. Fernando Garcia Mendes (Director of Drugs Authorization and Licensing – DIARE/ANVISA), welcomed the group to the 6th IGDRP meeting. The main focus of the IGDRP SC was a discussion of elements of the implementation plan for the consolidation of the IPRF and IGDRP initiatives.
Consolidation of the IPRF and IGDRP Initiatives
Leading up to the IGDRP SC discussions, a draft Implementation Plan and related documents for the consolidation were developed by a joint IGDRP/IPRF Implementation Task Group. These documents were discussed at the face to face meetings and progress was made on the proposed Terms of Reference (ToR), a governance structure, operational elements and communication strategies to facilitate a smooth transition towards the implementation of the consolidated initiative.
The new initiative will be named the International Pharmaceutical Regulators Programme (IPRP). IPRP will be officially launched on January 1, 2018 with the first face to face meeting of the IPRP’s Management Committee (MC) in June 2018 in Kobe City, Japan. The IPRP MC will work to elaborate a new strategic vision and finalise the ToR and governance structure for the consolidated entity. With funding provided by some of the regulatory authorities, the International Council for Harmonisation (ICH) Secretariat will provide support services to IPRP starting January 1, 2018.
IPRP is expected to create an environment for its members and observers to:
- exchange information on issues of mutual interest and enable cooperation amongst regulatory authorities and organisations;
- maximise synergies and avoid duplication of effort;
- create a regulatory hub for pharmaceuticals that covers all medicinal products; and
- enable closer linkages with other initiatives to simplify the numerous forms of international regulatory collaborations.
A new website will be developed and should be launched in the second quarter of 2018 to provide the new venue for communications on the activities and outputs of IPRP. Until such time that the new website will be operational, interested parties can continue to visit the websites of the two initiatives (www.i-p-r-f.org and www.igdrp.com).
Other Discussions of the IGDRP SC
The IGDRP SC discussed the results of the EU Decentralised Procedure (DCP) and Centralised Procedure (CP) Information Sharing Pilots. There was interest and support expressed for the continuation of these information sharing initiatives.
Updates were provided on the activities of the International Coalition of Medicines Regulatory Authorities (ICMRA), the Generic Medicines Working Group within the Australia, Canada, Singapore, Switzerland (ACSS) Consortium, the World Health Organization (WHO), and the Pan-American Network for Drug Regulatory Harmonization (PANDRH). Brazil’s ANVISA, Health Canada and Colombia’s INVIMA provided regulatory updates, in particular, with regard to new legislation, guidelines, and modernisation projects.
IGDRP currently operates two working groups that reported on progress and accomplishments made based on their work plans:
- Quality Working Group (QWG) reported minor revisions to the mandate, workplan and member list as well as updates on current projects. Notable outcomes from this meeting included agreement to:
- Publish the finalised Guidance for Quality Assessors – Drug Substance document for use by group members and external parties;
- Proceed with the launching of a pilot ASMF-DMF Database in the first quarter of 2018 to record the descriptive details of ASMF-DMFs submitted to participating project members. ASMF-DMF holders will be approached to participate following submission of an ASMF-DMF of interest.;
- Bioequivalence Working Group (BEWG) reported minor revisions to the mandate, workplan and member list as well as updates on current projects, such as:
- Biopharmaceutics Classification System (BCS) – based biowaiver requirements: the manuscript has been submitted for publication;
- Acceptability of a Foreign Comparator: the working group is preparing the final version of the manuscript for publication;
- Biowaivers for Additional Strengths: the working group is preparing the final version of the manuscript for publication and working on an assessment report template;
- Biowaivers for other dosage forms and approaches for selecting alternative comparator products: the surveys are completed and the working group is working on the manuscripts for publication; and
- Data integrity in BE studies: this is to be a standing agenda item in future meetings.
- The IGDRP SC noted that the working groups will meet face to face on May 16-17 2018 in Bern, Switzerland, back-to-back with the ACSS Consortium - Generic Medicines Working Group meeting that will be held on May 14-15 2018.
Next Meeting
The first meeting of the IPRP MC will be held on June 2-3, 2018 in Kobe City, Japan. For further information, please contact the IPRF Secretariat at nick.orphanos@canada.ca or the IGDRP Secretariat at IGDRPSecretariat@health.gov.au. Contact information for the new Secretariat of IPRP will be published following its launch in January 2018.
Link to websites:
Brasilia-
Brazil