HSA is part of the ACSS consortium in collaboration with Therapeutic Goods Administration (TGA) of Australia, Health Canada of Canada, and Swissmedic of Switzerland. The four regulatory agencies share the same desire to promote regulatory collaboration through working with trusted, like-minded regulators, adopt harmonised standards and share successes of existing models in order to meet the challenges of global issues.
There are several working groups under the Consortium, including the ACSS New Chemical Entities and Generic Medicines Working Groups which have embarked on various work sharing initiatives. Their goals are to harness efficiencies in the registration process, promote regulatory convergence of technical data requirements, build confidence between agencies and provide data to be used for the development of a ‘business as usual’ work sharing arrangement.
For more information on the work sharing initiatives, please click on the following links to access the relevant topics:
The New Chemical Entities (NCE) Working Group was established with the objective of creating opportunities and regulatory programmes for workshare through the greater alignment of regulatory approaches and technical requirements for NCE medicines. This is in view of the challenges faced by regulatory agencies, in particular the pressure on available resources to ensure timely access to effective new therapies with increasing workload and complexities of applications.
ACSS NCE Work Sharing Pilot (NCEWSP)
The NCE work sharing pilot (NCEWSP) is an innovative work sharing model for the coordinated assessment of an NCE application that has been filed with multiple ACSS Consortium agencies.
The ACSS NCE Working Group is currently actively seeking applications for this pilot, which covers new chemical or biological entity applications that are submitted to at least two ACSS regulators.
Please refer to the following documents for more details on NCEWSP and how to apply:
Applicants who are intersted in participating in this pilot should signal their interest by forwarding the completed Expression of Interest form to HSA_TP_Enquiry@hsa.gov.sg
The Generic Medicines Working Group (GMWG) was established with a specific focus on issues relating to generic medicines. The GMWG aims to:
Create opportunities and benefits for regulatory programmes through:
· Greater alignment of regulatory approaches and technical requirements
· More efficient use of resources through information and work sharing
· Establishment of an effective network among trusted, like-minded regulatory authorities
Produce immediate and ongoing results in priority work areas; and
Serve as a “proof of concept” for other international regulatory cooperation initiatives.
Please refer to the GMWG mandate for more details on the GMWG and its scope of activities.
Generic Medicines Work Sharing Trial (GMWST)
The Generic Medicines Work Sharing Trial (GMWST) is an innovative work sharing model for the coordinated assessment of a generic application that has been filed with multiple ACSS Consortium agencies.
Please refer to the following documents for more details on GMWST and how to apply.
- GMWST Notice to Applicants
- GMWST Operational Procedures;
- GMWST Expression of Interest Form (Word version); and
- GMWST Question and Answer Sheet.
Meetings and Communications
The GMWG meets bi-annually and also holds regular teleconferences to advance the work. For more information about the proceedings and notable outcomes from the face-to-face meetings, please refer to the Public Statements:
- 14-15 May 2018, Bern, Switzerland
- 27-28 October 2017, Brasilia, Brazil
- 1-2 June 2017, Ottawa, Canada
- 14-15 October 2016, Mexico City, Mexico
- 6-7 May 2016, Strasbourg, France