200. Where does the Centre for Innovation in Regulatory Science, of which John Skerritt is chair get its funding from? 201. Where does the International Coalition of Medicines Regulatory Authority of which the John Skerrit is the vice chair get its funding from?

Question Number: 112
PDR Number: SQ22-000160
Date Submitted: 24/02/2022
Department or Body: Department of Health

Response to Question 200

• The Centre for Innovation in Regulatory Science (CIRS) provides an international forum for industry, regulators, Health Technology Assessment (HTA) and other healthcare stakeholders to meet, debate and develop regulatory and reimbursement policy through the innovative application of regulatory science and to facilitate access to pharmaceutical products.

• Its funding is derived from membership dues, in kind time contributions of regulatory scientists and academics and research and training grants – for example from the Bill and Melinda Gates Foundation (to assist with the strengthening of regulatory systems in developing countries)

• Adjunct Professor Skerritt is not the “chair of CIRS” but rather the Chair of the CIRS Scientific Advisory Committee. This is a pro-bono role, and he does not receive any remuneration or other sitting fess from CIRS and has never received such fees. Seven of the world’s principal medicines regulators are members of the Scientific Advisory Committee. It has an advisory role only and not a governance role and includes the US Food and Drug Administration, European Medicines Agency, Pharmaceuticals and Medical Devices Agency (PMDA) Japan, health Canada,

• The National Medical Products Administration (NMPA) China, Swissmedic, along with the Therapeutic Goods Administration (TGA) Australia.

Response to Question 201

• The International Coalition of Medicines Regulatory Authorities (ICMRA) brings together the heads of 31 medicines regulatory authorities from every region in the world, with the WHO as an observer. Australia, through Professor Skerritt is the current Vice-Chair.

• ICMRA does not have a specific, free-standing budget and member regulators (including the TGA) do not pay any form of membership fee.

• Rather, member regulators contribute staff time to projects and meetings, with staff time funded by the budget of each regulator. The current chair, the European Medicines Agency, contribute staff resources to run the secretariat of ICMRA. In the last two years, all ICMRA activities have been virtual, with departmental staff involved in several meetings each month held in the late evenings Australian time.