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.

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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Common ASMF/DMF Submission Form (version 1.3, finalised March 2016)

News

The ability of IGDRP members to identify common ASMF/DMFs is a key focus of the IGDRP ASMF/DMF Working Group. Such identification would be facilitated if a common set of ASMF/DMF characteristics can be compared. Since key ASMF/DMF information is typically recorded by IGDRP members at the time of submission, ASMF/DMF Working Group members have worked to provide guidance on the type of information that should be recorded as part of an ASMF/DMF submission.

The resulting guidance is captured in the model Common ASMF/DMF Submission form.

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