The Quality Working Group (QWG) identifies opportunities for regulatory convergence and information sharing by exchanging and discussing information from members’ organisation regarding issues of common interest related to Quality information. The QWG also develops tools and templates and identifies best practices for the assessment of ASMFs/DMFs and drug product applications.
1. General Considerations
The medicines industry operates at a global level. Drug product manufacturers seek authorisation for the same, or essentially similar, drug product in multiple jurisdictions. Moreover, a single drug substance manufacturer may be supplying multiple drug product manufacturers with the same drug substance, supported by the same or essentially similar Active Substance Master File (ASMF)/Drug Master File (DMF).
Significant pressures are placed on regulatory authorities and organisations (RAs) tasked with the review and authorisation of these drug products. In addition to an increased workload associated with the growing number of drug applications, RAs must also contend with more sophisticated drug products and issues associated with complex global production and distribution chains.
Different procedures and technical requirements among RAs, together with limited operational mechanisms for effective information sharing among RAs, can present challenges to bringing safe, effective and high-quality medicines to the market in a timely manner.
Despite these pressures, the timely availability of quality medicines, plays an important role in helping to address rising health care costs and in promoting access to essential medicines worldwide. plays an important role in helping to address rising health care costs and in promoting access to essential medicines worldwide.
Quality issues that may arise for a specific drug product or drug substance often have widespread consequences across multiple RAs and a collaborative regulatory response to issues is beneficial.
Given these challenges, the benefits of regulatory cooperation, convergence and information sharing have long been recognised.
The strategic priorities of the IPRP create a pathway to respond to the challenges faced by RAs. They are relevant to information sharing; facilitating collaboration towards harmonisation and promoting regulatory convergence for the assessment of drug substance information (e.g., in ASMFs/DMFs) and drug products applications, to enhance the effectiveness and efficiencies of regulatory programmes.
The QWG identifies opportunities for regulatory convergence and information sharing by exchanging and discussing information from members’ organisation regarding issues of common interest related to Quality information. The QWG also develops tools and templates and identifies best practices for the assessment of ASMFs/DMFs and drug product applications, through:
- developing common assessment tools and approaches for the assessment of quality information related to drug substances and drug products;
- identifying opportunities and mechanisms to facilitate the sharing of information related to drug substances and drug products;
- creating and fostering a forum of regulatory authorities and organisations to discuss best practices, regulatory or technical challenges, and supporting convergence of regulatory practices, by identifying and resolving barriers to the implementation of ICH guidelines.
The scope of the QWG is aligned with that of activities as outlined in the IPRP Terms of Reference, but with a focus on: the implementation and interpretation of Quality requirements, the development of common assessment procedures and tools, the sharing of information related to ASMFs/DMFs and applications for drug products. This work is focused on small molecule/chemical entities and their associated drug products.
The QWG’s areas of work will complement and not duplicate established international initiatives and developments that are in progress.
4. Priority Work Areas
The QWG has completed the following key projects/initiatives:
- 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
- Guidance for Quality Assessors-Drug Product
- Quality Assessment Report (QAR - Full Dossier Template)
Projects currently active within the QWG include:
- ASMF/DMF Database
- Repository of Technical Issues of Interest (ROTII) – Drug Substances and Drug Products
- Survey on Administrative Procedures and Terminologies for Quality Variations/Post-Approval Changes
- Quality Assessment Report (QAR) template for Drug Product assessment
The QWG is constituted, in terms of size and representation, as determined by the IPRP Management Committee (MC) and its Terms of Reference.
The QWG is currently co-chaired by the European Directorate for the Quality of Medicines and Healthcare (EDQM) and Health Canada (Canada).