IGDRP Bioequivalence Working Group

Updates on the Bioequivalence Working Group

(Formerly known as the Biowaivers Working Group)

One of the priorities identified by IGDRP pertains to waivers of in vivo bioequivalence studies (Biowaivers). The application of scientifically based waivers to bioequivalence studies, which would normally be required to demonstrate the therapeutic equivalence of a generic and reference product, is important to avoid unnecessary testing in human subjects, reduce generic development costs and provide for a more efficient regulatory review process.

The  Biowaivers Working Group aims to promote greater collaboration, regulatory convergence, and potential mutual reliance on respective assessments in the longer term.

Formed in May 2013, this group sought to establish a common set of conditions for granting biowaivers as well as the possible expanded application of waivers.

At the 3rd meeting of the IGDRP (Strasbourg, May 2016), the group expanded its scope to bioequivalence and was renamed the Bioequivalance Working Group (BEWG) to reflect this development and the collaborations that are undertaken.

Objectives

  • Survey and collate information from each jurisdiction regarding issues of common interest related to the bioequivalence assessments of generic drugs. This information will be distributed via publication in scientific journals and on the IGDRP website.
  • Where appropriate, the Working Group will develop tools (e.g., assessment templates, and guidance for assessors) to aid in the assessment of bioequivalence.

Scope

The scope of the BEWG covers the application and interpretation of bioequivalence requirements as well as information and procedures for the assessment of bioequivalence.

Priority Work Areas

The BEWG has completed the following key project/initiative:

Public statements

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

Composition

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

Members

The following regulatory authorities and organisations are members of the BEWG: