Access Consortium New Active Substance (NAS) work-sharing initiative
The New Active Substance Work-Sharing Initiative (NASWSI) is an innovative work sharing procedure for the coordinated assessment of new chemical entity or new biological entity applications, or new indication applications that are submitted to two or more Access agencies.
By participating in this initiative, Access agencies are able to co-ordinate regulatory review procedures, and increase each agency’s capacity to ensure consumers have timely access to high quality, safe and effective therapeutic products.
For more information about work-sharing and its benefits for sponsors, see Australia-Canada-Singapore-Switzerland-United Kingdom (Access) Consortium.
New Active Substances approved through work-sharing
The TGA has approved the following medicines through the New Active Substance Work-Sharing Initiative (as of 30 September 2023):
2023
- mirikizumab (OMVOH)
- vadadustat (VAFSEO)
- concizumab (ALHEMO)
- Vibrio cholerae (VAXCHORA)
- dupilumab (DUPIXENT) [Extension of Indications]
- concizumab (ALHEMO) [Priority, Orphan]
- lumacaftor, ivacaftor (ORKAMBI) [Extension of Indications] [Orphan]
2022
- tirzepatide (MOUNJARO)
- difelikefalin (KORSUVA)
- faricimab (VABYSMO)
- asciminib (SCEMBLIX)
- dupilumab (DUPIXENT) [Extension of Indications]
- risankizumab (SKYRIZI) [Extension of Indications]
- glecaprevir, pibrentasvir (MAVIRET) [Extension of Indications]
- molnupiravir (LAGEVRIO) [Provisional]
2021
- cemiplimab (LIBTAYO) [Extension of Indications] [Provisional]
- cemiplimab (LIBTAYO) [Extension of Indications]
- somatrogon (NGENLA)
- finerenone (KERENDIA)
- avalglucosidase alfa (NEXVIAZYME)
- vericiguat (VERQUVO)
- human fibrinogen, human thrombin (VERASEAL)
- inclisiran (LEQVIO)
- isatuximab (SARCLISA) [Extension of Indications]
- ofatumumab (KESIMPTA) [Extension of Indications]
2020
- isatuximab (SARCLISA)
- tafamidis (VYNDAMAX)
- tafamidis meglumine (VYNDAQEL)
- baloxavir marboxil (XOFLUZA)
- darolutamide (NUBEQA)
2019
- niraparib (ZEJULA)
- abemaciclib (VERZENIO)
2018
- apalutamide (ERLYAND, JANSSEN APALUTAMIDE) [Priority]
How to submit an application for New Active Substance work-sharing
Access NASWSI is actively exploring opportunities for work-sharing with industry and is seeking applications for this initiative. Applicants who are interested in taking part in this initiative should:
- Review the Operational Procedures (OP) document below which outlines the operational steps, target milestones and recommendations for the planning and filing of an application.
- Download and complete the Expression of Interest (EOI) form below to express interest in participating in work-sharing.
- Submit your completed EOI form to at least two of the Access Consortium members listed below via email. To be considered as a suitable candidate for this work-sharing initiative, submit your applications simultaneously to participating members.
Please include 'Access Consortium - NAS work-sharing' in the subject line of your email.
- Australia: streamlinedsubmission@health.gov.au
- Canada: HC.tpd.international-dpt.SC@canada.ca
- Singapore: HSA_TP_Enquiry@hsa.gov.sg
- Switzerland: Networking@swissmedic.ch
- United Kingdom: access-mhra@mhra.gov.uk