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New chemical entities added to ACSS work-sharing pilot Posted 25/05/2018

Australia’s drug regulatory agency, the Therapeutic Goods Administration (TGA) announced on 17 April 2018 that it had established a new chemical entity work-sharing pilot with Health Canada.

Australian and Canadian officials are entering into the pilot project as part of the Australia-Canada-Singapore-Switzerland (ACSS) Consortium. The ACSS Consortium is a collaborative initiative of like-minded, medium-sized regulatory authorities and includes the TGA, Health Canada, Singapore’s Health Sciences Authority (HSA) and the Swiss Agency for Therapeutic Products (Swissmedic).

The New Chemical Entities (NCE) Working Group was formed to focus on developing opportunities within regulatory programme through the greater alignment of regulatory approaches and technical requirements.

Under the programme, the two regulatory bodies will collaborate on reviewing NCE files to increase efficiency. Each agency will evaluate its respective Module 1 and process Module 5, which covers clinical matters, separately. Health Canada will then evaluate the quality-focused Module 3, while the TGA will take the lead on the toxicology-focussed Module 4. They will then assess the practicalities of undertaking a coordinated assessment that will complement the regulatory decision-making within each jurisdiction.

The NCE pilot follows an expansion of the ACSS generic drug work-sharing trial in December 2017.

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Source: TGA

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