International cooperation on therapeutic products

First application reviewed by all five Access Consortium Authorities


On 25 May 2022, Swissmedic, the Swiss Agency for Therapeutic Products – in cooperation with its partner authorities Health Canada (HC), Health Sciences Authority (HSA) Singapore, the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom and Australia’s Therapeutic Goods Administration (TGA) in the Access Consortium “New Active Substance Work Sharing Initiative” (NASWSI) – authorised the medicinal product Vabysmo® (active substance: faricimab), solution for injection for intravitreal use for the treatment of neovascular (wet) age-related macular degeneration (nAMD) and for the treatment of diabetic macular oedema (DME).

This was the first application reviewed by all five Access authorities. The principal review activities were divided up as follows: Module 3 Drug Substance: HSA, Module 3 Drug Product: Swissmedic, Module 4: TGA, Module 5: HC and MHRA. In addition, all modules were subjected to peer review. A consolidated List of Questions was sent to the marketing authorisation holder and timelines were synchronised except for the national labelling phase. The decision as to whether to authorise the medicinal product was taken independently by each authority after the review.

Swissmedic granted authorisation for faricimab after a review period of 212 days only.

The Access Consortium is an alliance of like-minded regulatory authorities. It has been established to promote regulatory convergence and exploit synergies thereby enhancing the efficiency of the regulatory systems and optimising the demand for resources. The NASWSI offers a global collaboration platform between Access authorities and the pharmaceutical industry and may be considered for new active substance applications as well as for extensions of indications.