On 1 February 2021, Swissmedic, the Swiss Agency for Therapeutic Products – in cooperation with its partner authorities Health Canada (HC), Health Science Authority (HSA) Singapore and Australia’s Therapeutic Goods Administration (TGA) in the Access Consortium “New Active Substance Work Sharing Initiative” (NASWSI) – authorised the medicinal product Kesimpta® (active substance: ofatumumab) for the treatment of adult patients with active, relapsing-remitting forms of multiple sclerosis (MS).
This was the first application to be reviewed by means of a division of tasks between four authorities. The principal review activities were divided up as follows: Module 3: HSA, Module 4: Swissmedic, Module 5: TGA, biostatistics: HC. In addition, all modules were subjected to peer review. Each authority independently reviewed its own country-specific Module 1 and the Risk Management Plan. A consolidated List of Questions was sent to the marketing authorisation holder, and timelines were synchronised up until 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 ofatumumab after a review period of just 243 days.
The Access Consortium is an alliance of “like-minded” regulatory authorities. The purpose of the consortium is to exploit synergies, share knowledge among the regulatory authorities and thereby enhance the efficiency of the regulatory systems and optimise the demand for resources. The NASWSI currently offers a standard and fast-track procedure for new active substances, as well as a procedure for extensions of indications.