Access Website FAQs

Questions	Suggested Answer
Will there be additional countries added to the Access Consortium?	It is not our current priority to add to the Access membership. Access started with four members and has, over the past few years, successfully integrated our fifth member, the United Kingdom’s Medicines and Healthcare products Regulatory Agency. We are now consolidating the benefits of work-sharing and other collaborations across the five current members. We remain open-minded about opportunities to work with individual regulators on specific applications, where relevant. For details on the membership criteria for the Consortium, please refer to the Access Consortium Terms of Reference. Please note that there is currently no provision for observers to join Access.
What is the unique selling point / value proposition of Access vs other markets?	Access’ work-sharing initiatives provide: coordinated medicine application review process giving potential access to a combined population of 150 million people a consolidated list of questions from trusted regulators to simplify the evaluation process predictable timelines, comparable to other leading regulatory procedures
Will the scope of Access expand to cover medical devices and/or other innovative products, including AI as a medical device?	There are currently no plans to expand the scope of the Access Consortium's work-sharing activities to include medical devices, including AI as a medical device, or other innovative product categories beyond medicines. While Access members remain committed to exploring opportunities for regulatory collaboration where appropriate, medical devices are regulated under different regulatory frameworks across member jurisdictions. These differences make meaningful work-sharing in this area challenging at this time. The Consortium will continue to focus on strengthening collaboration within its existing scope of improving access to safe, effective medicines, while monitoring developments and sharing information on emerging regulatory issues where this adds value without requiring formal work-sharing.
How do sovereign national decisions impact the consistency of approvals across Access Consortium countries despite joint assessments?	The risk of divergent decisions between agencies is likely reduced compared to separate national applications, since in an Access Consortium work-sharing procedure all parties assess the same data and engage in scientific discussions to build a shared understanding. However, differences in outcomes may still occur - the most common example of this is differences in the product information, which follows national requirements. True divergent decisions – where one Access agency approves an application while another Access agency refuses an application – are very rare, since we are like-minded regulators with shared scientific approaches. Appropriate mechanisms are in place when divergent opinions arise, including the provision that each jurisdiction retains its decision-making authority.
What is the relationship between decisions made by Access regulators and HTAs?	Access Consortium regulators are responsible for assessing the quality, safety and efficacy of therapeutic products and making independent regulatory decisions within their respective legal frameworks. These decisions are separate from those made by health technology assessment (HTA) organizations, which evaluate the clinical and cost-effectiveness of products to inform reimbursement and funding decisions. Several Access regulators have established processes to conduct aligned and/or parallel reviews with their respective HTA organizations to help facilitate timely patient access and reduce duplication where appropriate.
How does the Access work-sharing procedure compare to FDA or EMA timelines?	We consider the timelines offered through Access work-sharing procedures to be competitive with EMA and FDA timelines. The Access work-sharing model also reduces duplication, shares scientific workload between regulators and supports near-concurrent patient access to the same medicine in multiple markets.
What is the Trusted Regulatory Space and when will it launch? How will it change the sponsor experience?	The Trusted Regulatory Space (TRS) is a shared digital platform that allows improved collaborative efficiency and supports harmonized review processes across Access regulatory agencies, providing a more effective and streamlined review experience for agencies and improved submission tracking. We plan to rollout the platform in late 2026 with a controlled soft launch involving a limited number of selected submissions before full-scale implementation.
When should Access be the first choice for a global filing strategy?	When used early in global filing planning – especially for multi-country launches. The greatest value comes from proactive integration, not retrofitting.
Are post-approval changes possible through Access?	For the time being, post-approval changes are only possible if they are in relation to an application for a new indication. For the future, it is being discussed if the scope can be broadened, in particular regarding line extensions and post-approval changes.
How do you decide which agency leads on the assessment of Module 3, 4, 5?	Decisions are made on a case-by-case basis, depending on resources and expertise within each agency.
What do you do if different agencies reach a different opinion?	The Access agencies will: independently inform the local applicant of their decision to grant or refusal to grant market authorisation publish a public assessment report or similar document in accordance with their usual national procedures. These communications may not be simultaneous. 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. Where an application is not considered approvable by an Access agency, its national procedures will apply.
Can Access assessment reports be used as a basis for reliance in other non-Access countries?	Non-Access regulators and/or pharmaceutical companies may wish to use the underlying assessment/s from an Access work-sharing procedure as the basis for reliance, depending on national reliance frameworks. Access partners will look to facilitate requests to share reports for the procedures they have participated in, where possible. Alternatively, non-Access regulators may wish to request assessment reports directly from a company for its product/s which have been assessed through an Access work-sharing procedure.
Does Access have a coordinated pathway for paediatric approvals?	The Access Consortium does not have a dedicated coordinated paediatric approval pathway.
What is the Access Promise Pilot Pathway? How does the prioritisation process work across multiple agencies?	Details of the Promise Pilot Pathway can be found in the New Active Substance Work-sharing Initiative (NASWSI) Operational Procedures. Access_NASWSI_-_Operational_Procedures_-_v1.2.pdf A specific Q&A document for the Promise Pathway is also available, providing additional details regarding the Promise procedure. https://accessconsortium.info/Promise%20QandA%20for%20publication_final.pdf