New chemical entities added to ACSS work-sharing pilot

Home/Policies & Legislation | Posted 25/05/2018 post-comment0 Post your comment

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.

Review committee V15a16

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.

Related article
Comments on TGA’s modified approach to naming biologicals

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2018 Pro Pharma Communications International. All Rights Reserved.

Source: TGA

comment icon Comments (0)
Post your comment
Related content
USA BIOSIM Act introduction
02 AA010638
Home/Policies & Legislation Posted 17/09/2021
MERCOSUR: new tariff for biological and biosimilar without Latin equity
138 AA011155
Home/Policies & Legislation Posted 03/09/2021
New trade agreement between Mexico, the US and Canada
62 MD001919
Home/Policies & Legislation Posted 27/08/2021
Most viewed articles
About GaBI
Home/About GaBI Posted 05/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010