Quality

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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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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ASMF/DMF Lexicon of Quality Terms (version 1.2, finalised May 2015)

News

IGDRP ASMF/DMF Working Group members come from a variety of Regulatory Authorities (RA’s) from around the world; each with their own regulatory terminology.

To ensure a common understanding among members, a Lexicon of Quality Terms has been developed for use by members and for use in documents produced by the IGDRP ASMF/DMF Working group. Since this may also be of benefit to the broader regulatory community, the decision was made to publish these terms and the result is the ASMF/DMF Lexicon of Quality Terms.

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2nd International Generic Drug Regulators Programme (IGDRP) – Active Substance Master File (ASMF)/Drug Master File (DMF) Working Group - Public statement

News

With a view to improving international cooperation and work-sharing in the assessment of ASMF/DMF for generic drugs, the members of the ASMF/DMF Working Group held a face to face meeting as part of the 2nd meeting of the International Generic Drug Regulators Programme (IGDRP) in Seoul, South Korea from 2-5 November 2015.

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The 1st International Generic Drug Regulators Programme (IGDRP) - ASMF/DMF Working Group - Public statement

News

The IGDRP ASMF/DMF working group was formed in May 2013 to foster international collaboration and worksharing in the area of evaluations for ASMFs/DMFs during the review of a generic drug product.

From the outset, this working group was provided with a mandate and scope to progress a number of overarching projects, including conducting the ASMF/DMF Gap Analysis Survey of technical requirements, procedures and systems, creating Common ASMF/DMF Quality Use Report (QAR) Templates and developing Common Guidance for Quality Assessors for the assessment of ASMFs/DMFs.

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1st Meeting of the International Generic Drug Regulators Programme, Pretoria, 27-28 May 2015

News

The International Generic Drug Regulators Programme (IGDRP) was formed following progression from its 3-year Pilot phase and continues to promote collaboration and convergence in generic drug regulatory programs in order to address the challenges posed by increasing workloads and complexity of scientific issues.

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