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EDQM’s International API Convergence Efforts Encompass Generics Regulator Forum IGDRP, Monographs and Inspections

Apr 4th, 2016

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The efforts by the European Directorate for the Quality of Medicines (EDQM) to further API quality regulatory harmonization include its participation in the International Generic Drug Regulators Program (IGDRP), which released in March a common form for submitting drug master files for active substances (ASMF/DMF), a common template for reviewing them, and a lexicon of common terms. 

IGDRP was formed in 2011 as a three-year pilot to promote collaboration and convergence of generic drug technical and regulatory requirements among participating countries in order to address challenges posed by increasing workloads, globalization and the complexity of scientific issues.  After the pilot effort came to a conclusion in 2014 (IPQ August 16, 2014), the group chose to establish itself as an ongoing program for international collaboration in the assessment of generic drugs.

IGDRP currently has three working groups that are focused on: ● ASMF/DMF issues ● biowaivers, and ● the work-sharing model using the EU decentralized procedure model for countries outside the EU.  The three documents released in March are the product of the ASMF/DMF working group.

At the APIC/CEFIC annual “European Conference on Active Pharmaceutical Ingredients,” held in Amsterdam, the Netherlands, in November 2015, EDQM Certification Division Head Helene Bruguera, a member of the IGDRP ASMF/DMF working group, shared her insights on the progress the group is making as part of a presentation centered on EDQM’s harmonization activities.

Bruguera explained that IGDRP includes about 15 countries (see box on the next page for a list of members), “with a real wish to do regulatory convergence, cooperation, and exchange of information in the area of generics.”  Bruguera attended the IGDRP meeting in Seoul, South Korea, that immediately followed the APIC meeting.

In addition to the IGDRP efforts, Bruguera addressed: ● the current activities of the European Pharmacopeia (EP) ● the impact of ICH Q3D on EP monographs ● pharmacopeial harmonization, including a Good Pharmacopeia Practices (GPhP) initiative ● recent developments regarding the CEP procedure, including the impact of ICH Q3D ● the EDQM inspection program ● ASMF work sharing and a pilot on how ASMFs can inform CEP assessments, and ● other harmonization efforts EDQM is involved in.

Bruguera concluded with a provocative comparison of her presentation with the one she gave at the 2007 APIC meeting – including what topics were addressed and what has and has not changed in the intervening eight years.  [Editor’s Note: Bruguera’s presentation at the 2007 APIC meeting is provided in the IPQ Monthly Update for November/December 2007, pp. 12-21. Her complete remarks at the 2015 conference are provided below.]

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