The Quality Working Group for Generics (QWGG) focuses on technical requirements, procedures and tools for the assessment of Quality information related to ASMFs/DMFs and generic drug products.
One of the priorities identified by the IPRP pertains to technical requirements, regulatory procedures and the assessment of Quality information in Active Substance Master Files (ASMFs)/Drug Master Files (DMFs), and marketing applications for generic drug products, to enhance resource savings and efficiencies through work sharing. This is with a view to enhancing collaborative efforts and regulatory convergence, and the potential reliance on respective assessments in the longer term. The working group efforts are also expected to assist in mitigating some issues in the regulation of pharmaceuticals (e.g. those associated with drug shortages).
The work of the IPRP Quality Working Group for Generic (QWGG) is currently focussing on information related to ASMFs/DMFs deriving from the fact that:
- the review of ASMFs/DMFs may be subject to fewer complicating factors associated with drug products (such as formulation and manufacturing differences);
- there have been considerable achievements in the harmonisation of Quality standards applicable to ASMFs/DMFs (for example, through the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)); and
- one ASMF/DMF may be cross-referenced in multiple marketing applications filed with multiple Regulatory Authorities (RAs).
This last consideration increases both the overall significance and value of regulatory cooperation and information sharing related to the generic drug review process, as well as the likelihood of matches amongst RAs for the same Active Pharmaceutical Ingredient (API) from the same manufacturing source.
The ability of RAs to share information on best practices, promote regulatory convergence of technical requirements and utilise ASMF/DMF assessments from other RAs has the objective of increasing the efficiency and effectiveness of the generic drug review process while reducing regulatory burden. It is also expected to strengthen the ASMF/DMF and API assessment processes, promote the timely sharing of information about API sources of concern and facilitate the identification of alternate sites of acceptable APIs (for example, in the case of drug shortages).
In 2016, at a time when the group was working within the International Generic Drug Products Regulators (IGDRP), the decision was taken to expand the scope of the Working Group to enable discussions and activities on Quality aspects related to information associated with marketing applications for generic drug products, while continuing to focus on ASMFs/DMFs. The group was renamed the Quality Working Group to reflect this development and the collaborations that are undertaken.
Establish a framework and mechanisms for information sharing and work sharing of Quality information. This is with a view to greater collaboration and potentially regulatory convergence in the assessment of ASMFs/DMFs and applications for generic drug products taking into account international initiatives, best practices and ongoing developments.
The information sharing and work sharing projects of the QWGG focus on technical requirements, procedures and tools for the assessment of Quality information related to ASMFs/DMFs and generic drug products.
Priority Work Areas
The QWGG has completed the following key projects/initiatives:
- ASMF/DMF Database
- Lexicon of Quality Terms
- Common ASMF/DMF Submission Form
- Quality Assessment Report (QAR) template for ASMFs/DMFs
- Gap Analysis on ASMF/DMF frameworks and procedures
- Criteria for when a separate ASMF/DMF should be submitted
- Guidance for Quality Assessors-Drug Substance
- ASMF/DMF Working Group public statement - IGDRP1 - 25 to 26 May 2015
- ASMF/DMF Working Group public statement - IGDRP2 - 2 to 3 November 2015
The QWGG is constituted, in terms of size and representation, as determined by the IPRP Management Committee (MC) and its Terms of Reference.
The QWGG is currently co-chaired by the European Directorate for the Quality of Medicines and Healthcare (EDQM) and the World Health Organization (WHO).