IGDRP Quality Working Group

Updates on the Quality Working Group

(Formerly known as the Active Substance Master File/Drug Master File (ASMF/DMF) Working Group)

One of the priorities identified by the International Generic Drug Regulators Programme (IGDRP) 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 IGDRP Quality Working Group (QWG) 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 has been considerable advancement 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).

The ASMF/DMF Working Group was formed in May 2013 to establish a framework and mechanisms for enhanced information sharing and the use of ASMF/DMF assessments, and the possible future reliance on the assessments of the participating RAs.

At the 3rd meeting of the IGDRP (Strasbourg, May 2016), the ASMF/DMF Working Group decided to expand its scope 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.

Objectives

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.

Scope

The information sharing and work sharing projects of the QWG 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 QWG has completed the following key projects/initiatives:

Public statements

Note: From May 2016 onward, updates on the work of the QWG following the meetings can be found within the public statements issued by the IGDRP Steering Committee.

Composition

The QWG will be constituted, in terms of size and representation, as determined by the IGDRP Steering Committee (SC) and its Terms of Reference. Nomination of the QWG Chair or Co-Chairs by the QWG members must be endorsed by the SC. Appointment terms are for 3 years, renewable at the discretion of the SC.
The QWG is currently co-chaired by Australia’s Therapeutic Goods Administration (TGA) and the World Health Organization (WHO). 
Participation in the QWG is open to all IGDRP members. Individual members of the QWG are nominated by the respective IGDRP jurisdictions. If included, the nomination of external experts to the QWG is based on their expertise in the specific subject matter and their ability to actively contribute to the activities of the Working Group. The QWG can also accommodate members who would prefer to participate as observers only.

Members

The following regulatory authorities participate in the ASMF/DMF Working Group: