News

Overviews of all the latest meetings held by IGDRP are available here. For a list of recent documents published by IGDRP, see the Documents page.

The IGDRP agrees on a path forward and a new name - the International Pharmaceutical Regulators Programme (IPRP) for the consolidation of its operations with the International Pharmaceutical Regulators Forum (IPRF)

  • by IGDRP - 8 December 2017 - 11:15am
News

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.

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Guidance for Quality Assessors –Drug Substance (Ver 1.0, finalised June 2017)

  • by IGDRP - 28 November 2017 - 2:21pm
News

This document is primarily intended for Quality Assessors within Regulatory Agencies to facilitate the preparation of the Quality Assessment Reports (QARs), by providing guidance and assistance to Quality Assessors in the review of the technical information contained in the Quality Module (Module 3) of Active Substance Master Files (ASMFs)/Drug Master Files (DMFs) and marketing authorisation applications (MAAs).

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5th Meeting of the International Generic Drug Regulators Programme, Ottawa, Canada, 5-8 June 2017

  • by IGDRP - 30 August 2017 - 3:23pm
News

Members and Observers of the International Generic Drug Regulators Programme (IGDRP) participated in its 5th meeting which took place in Ottawa, Canada from June 5th-8th, 2017. Concurrent meetings of the IGDRP Quality Working Group (QWG) and the IGDRP Bioequivalence Working Group (BEWG) took place on June 5th-6th. The Steering Committee (SC) meeting took place on June 7th-8th and was chaired by Health Canada and co-chaired by the Federal Commission for the Protection against Sanitary Risk (COFEPRIS).

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Criteria for when a Separate ASMF/DMF should be Submitted

News

A common question often arises as to what differences in API-details may be included in a single ASMF/DMF and under what circumstances should a separate ASMF/DMF be submitted.

The IGDRP performed a Gap Analysis of the ASMF systems in the various IGDRP jurisdictions and a questionnaire was also circulated among members to ascertain the criteria for issuing a new ASMF.

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Regulatory Collaboration and Emerging Issues in Generic Medicines - IGDRP and other Initiatives Responding to Today’s Demands and Future Challenges

  • by IGDRP - 19 May 2017 - 11:37am
News

June 9, 2017 (Ottawa, Ontario)

The availability of quality medicines plays an increasingly important role in helping to address rising health care costs and in promoting access to essential medicines worldwide. The International Generic Drug Regulators Programme (IGDRP) was created to promote collaboration and convergence in generic drug regulatory programs in order to address the challenges posed by increasing workloads, globalisation and complexity of scientific issues.

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4th Meeting of the International Generic Drug Regulators Programme, Mexico City, Mexico, 17-20 October 2016

  • by IGDRP - 7 March 2017 - 9:40am
News

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:

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IGDRP Roadmap to 2020

  • by IGDRP - 21 December 2016 - 12:07pm
News

 The availability of quality generic medicines plays an increasingly important role in helping to address rising health care costs and in promoting access to essential medicines worldwide. This, however, has led to significant pressures on regulatory authorities (RAs) tasked with the review and authorisation of these drug products. Among other objectives, the IGDRP initiative has the ambition to increase the efficiency of review procedures and reduce regulatory burden without comprising the safety, efficacy, and quality of generic medicines.

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Regulatory Collaboration - IGDRP generic drug product regulatory gap analysis

  • by IGDRP - 29 November 2016 - 4:20pm
News

The Brazilian Health Regulatory Agency (ANVISA) led a regulatory gap analysis survey under the auspices of IGDRP to identify regulatory similarities amongst the IGDRP members, and gaps that may create challenges for work-sharing and collaboration. The survey of the World Health Organization’s (WHO) Prequalification Team, the European Union, and 11 Regulatory Authorities covered the definition of a generic drug product and various regulatory and registration requirements for generic drugs, such as: 

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Gap Analysis on ASMF/DMF frameworks and procedures

News

- J Pharm Pharm Sci. 2016 Apr-Jun; 19(2):290-300

By Pharmaceuticals and Medical Devices Agency(PMDA), Japan– 5  August  2016

The PMDA, on behalf of the IGDRP, investigated and have published a Gap Analysis on the ASMF/DMF frameworks and procedures of IGDRP members.  This paper has been published in the Journal of Pharmacy and Pharmaceutical Science entitled: Similarities and Differences of International Practices and Procedures for the Regulation for Active Substance Master Files/Drug Master Files of Human Use: Moving Toward Regulatory Convergence.

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