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


The IGDRP Biowaivers working group was formed in May 2013 with the objective of establishing a common set of conditions for the granting of biowaivers as well as the expansion of the application of waivers. From the outset, this working group was provided with a scope and workplan to progress work on the use of Biopharmaceutical Classification System (BCS)-based biowaivers, biowaiver for additional or non-biostudy strengths of a solid dosage form product line, and biowaivers for certain dosage forms, e.g. solutions for parenteral, oral or local use .

The Biowaivers working group met on 25 and 26 May 2015 in Pretoria, South Africa, with representatives from ANVISA, COFEPRIS, Health Canada, the Health Sciences Authority (HSA), the Medicines Control Council (MCC), the Ministry of Food and Drug Safety (MFDS), the Pharmaceuticals and Medical Devices Agency (PMDA), Swissmedic, the Taiwan Food and Drug Administration (TFDA) and the Therapeutic Goods Administration (TGA), as well as observers from the World Health Organization (WHO).This meeting was also attended by observers from the Medicines Control Authority of Zimbabwe (MCAZ) as a representative of the Southern African group of agencies (ZAZIBONA) who are involved in a similar regulatory harmonisation initiative. US FDA also actively contributes to this work group via teleconferences.

At this meeting, the working group reported on the progress of several projects including:

  1. The requirements and use of BCS biowaivers in each jurisdiction/country.
  2. The completion of the assessment report template for BCS based biowaivers, which can be used also as guidance for assessors.
  3. The proposal of the publication of a scientific paper concerning BCS biowaivers requirements among IGDRP members.
  4. Initial review of requirements for biowaivers for additional/proportional strengths in a product line.
  5. Location within the submission dossier of the documentation for a BCS biowaiver.
  6. Other technical discussion, e.g. how to compare dissolution profiles when variability is higher than acceptable for f2 similarity factor calculation.

The group also decided to expand the scope of activity to include bioequivalence issues outside of biowaivers, e.g. requirements for accepting a foreign reference product.

The application of scientifically based waivers of bioequivalence studies (normally required to demonstrate the therapeutic equivalence of a generic and reference product) in a consistent manner in the different countries is important to avoid unnecessary testing in human subjects, reduce generic development costs and ultimately provide a more efficient regulatory review process.