2nd International Generic Drug Regulators Programme (IGDRP) - Biowaivers Working Group - Public statement

  • by IGDRP - 20 April 2016 - 3:50pm

The Biowaivers Working Group held a face to face meeting on 2-3 November 2015 as part of the 2nd meeting of the International Generic Drug Regulators Programme (IGDRP) in Seoul, South Korea, with a view to facilitate conditions which enable greater inter-agency collaboration.

The Biowaivers Working Group meeting was attended by representatives from ANVISA, COFEPRIS, the European Union (EU), Health Canada, Health Sciences Authority (HSA), Ministry of Food and Drug Safety (MFDS), Pharmaceuticals and Medical Devices Agency (PMDA), Swissmedic, the Therapeutic Goods Administration (TGA), and the World Health Organization (WHO). US FDA, in its capacity as an observer, also contributes actively to the objectives of this Working Group.

At this meeting, the Working Group members provided an update on the progress of several projects:

  • The survey of the Biopharmaceutics Classification System (BCS) Biowaivers requirements is now complete and the manuscript will be published soon.
  • The initial survey on Waivers for additional non-biostudy strengths has been completed. The Working Group is now working on a manuscript describing similarities and differences between regulators.
  • Tracking new BCS classification decisions will be undertaken as an ongoing project.
  • The survey on Biowaivers for dosage forms was reviewed. The survey covered dosage forms for oral solutions, intravenous solutions, intramuscular  and subcutaneous  solutions, emulsions for injections, inhaled products, tropical products, suppositories, otic/ophthalmic solutions.
  • A survey on the acceptability of foreign reference products is underway. This will be used to identify the jurisdictions that can accept a foreign reference product and under what conditions.

A number of participating regulators shared information on new legislation and policies on biowaivers.

According to the mandate, the Biowaivers Working Group intends to expand its scope to include broader bioequivalence issues.

The next face to face meeting of the Biowaivers Working Group is scheduled to take place on 9-10 May 2016, as part of the IGDRP meeting in Strasbourg, France.