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.

Consolidation to create synergies in international collaboration: IGDRP and IPRF become IPRP

  • by IGDRP - 7 February 2018 - 7:29pm
News

Back in 2016, discussions started about a possible consolidation of the two initiatives, the International Generic Drug Regulators Programme (IGDRP) and the International Pharmaceutical Regulators Forum (IPRF). Both initiatives had complementary objectives and a largely overlapping membership of regulatory authorities and organisations, but a different scope of products: IPRF focused on innovative pharmaceutical products and technologies, IGDRP focused on issues of interest relating to generic products.

Read More

Publication of a Survey of the Regulatory Requirements for BCS-Based Biowaivers for Solid Oral Dosage Forms by Participating Regulators and Organisations of the IGDRP

  • by IGDRP - 6 February 2018 - 11:29pm
News

The Bioequivalence Working Group has conducted a survey of the participants’ requirements for Biopharmaceutics Classification System (BCS) based biowaivers. The BCS based biowaiver is a scientific model which enables the substitution of in vivo bioequivalence studies with in vitro data as evidence of therapeutic equivalence subject to certain conditions. Despite being based on the same principles, BCS-based biowaivers are interpreted and regulated differently among international regulatory agencies.

Read More

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.

Read More

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).

Read More

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).

Read More

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.

Read More

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.

Read More

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:

Read More

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.

Read More