Access Website FAQs

Questions	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 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?	We regularly consider new potential areas of collaboration for Access partners, including how emerging areas of interest could build on the work-sharing initiatives being developed under the Access Consortium. Access members collaborate in a large number of medical device areas bilaterally, multilaterally and via existing international medical device harmonization initiatives. Whilst we continue to explore new possibilities for Access’ scope, our core vision remains focused on consolidating current frameworks to improve access to safe, effective medicines. Each of the five agencies have slightly different regulatory regimes within their own jurisdictions, particularly for medical devices. It is not our core focus for the foreseeable future.
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 initiative 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.
What is the relationship between decisions made by Access regulators and HTAs?	The Access pathway can speed up regulatory approvals across countries, but companies must still prepare separate HTA submissions with country-specific economic data. Regulators do not decide how (or whether) medicines are paid for, which remains the domain of national HTA bodies. Several Access regulators participate in parallel regulatory-HTA assessment initiatives with their respective national HTAs. Aligned reviews between regulators and HTA organisations allow drug sponsors to undergo parallel evaluations, aiming to minimize the time lag between regulatory market authorisation and public funding recommendations.
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 under development. This platform will allow improved collaborative efficiency and support harmonized review processes across Access regulatory agencies, providing a more effective and streamlined review experience for both agencies and users and improved submission tracking. The platform will be piloted with a controlled soft launch involving a limited number of selected submissions before full-scale implementation. TRS enables real-time regulator collaboration and assessment sharing. While mostly behind the scenes, industry will experience faster, smoother, and more coordinated reviews.
When should Access be the first choice?	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, only if they are in relation to a new indication submission.  For the future, it is being discussed, if the scope can be broadened up, 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 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?	The Access Consortium does not issue a single joint assessment report that is formally recognized worldwide. Each Access regulator makes its own sovereign decision, and the detailed assessment reports are owned by the participating agencies. However, 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.
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. A specific Q&A document for the Promise Pathway is also available, providing additional details regarding the Promise procedure.