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Alleviating Regulatory Burden Through Access Consortium 

While regulatory authorities are in- creasingly adopting reliance programs to assess applications, few offer the opportunity to take advantage of simultaneous assessment and approval timelines across borders and juris- dictions. This is what differentiates the Access Consortium, which provides joint scientific advice and work-sharing, reducing duplication and accelerating access to high-quality medicines for patients in need. The collaborative pathway alleviates the burden for both the health authority and the sponsor or marketing authorisation holder (MAH), enabling the submission of one dossier for all participating markets simultaneously. As part of a push for greater harmo-nisation of regulatory policy, Australia’s Therapeutic Goods Administration (TGA), Health Canada (HC), Singapore’s Health Sciences Authority (HSA) and Swissmedic formed the Access Consortium in 2007.3

Thirteen years later, following Brexit, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has joined the fold.

How Work-sharing Works

Unlike reliance programs, where one national authority will consider assessments by another, Access is a work-sharing program, where member countries involved in an application agree to divide the modules according to their capability, experience and capacity.

All participating authorities agree to set evaluation times before the process begins, which gives sponsors a clearer timetable and enables teams to plan and prepare their organisational strategy.

Each agency then delivers their module- specific assessment report and list of questions to the other partner agencies. The consolidated assessment report and questions reflecting concerns regarding Modules 2 to 5 are then sent to the MAH, which is requested to provide responses within a defined time frame.

The country responsible for a specific module evaluates the responses and, if required, the other agencies may submit an additional set of questions for clarification.6

While differences between the modules are accepted, MAHs are asked to outline those in the information provided to each authority. Participating members discuss the differences to determine whether the application is suitable for a work-sharing arrangement.

Module 1 is treated differently because of the country-specific content and is reviewed separately by each participating agency.

At the end of the review period, each authority issues its decision on marketing authorisation independently.

Market authorisation or refusal of market authorisation by one regulator will not affect the decision or the timing of the decision by the remaining participating regulators.6

While indications and final product labelling could differ slightly in each country, the core evaluation and conclusion is common, which is quite similar to Europe’s Decentralised Procedure (DCP), where one agency acts as a reference regulatory agency (RRA) and evaluates Modules 2 to 5.

Strengthening Processes

The Access Consortium has in the past few years taken steps to strengthen its processes. There are now several working groups that support a range of activities across active substances, generics and IT architecture, as well as the more recent addition of a group dedicated to advanced therapy medicinal products (ATMPs).

Interest in the Access pathway appears to be gaining momentum. According to the TGA, the first two submissions to all five agencies were approved through the New Active Substances Work-Sharing Initiative (NASWSI) in 2022–2023. Asciminib (Scemblix®) was approved by all five markets for the treatment of Philadelphia chromosome- positive chronic myeloid leukaemia, and Faricimab (Vabysmo®) was approved to treat macular degeneration.