The Access Consortium is another framework for sharing regulatory assessment between authorities. As opposed to Project Orbis, which is open only to oncology products, Access admits applications covering all therapeutic areas. The unique feature of Access is that the modules are distributed and assessed by different regulators, sharing the outcome so that each agency can make an independent ruling. By sharing resources and expertise, work-sharing could ultimately increase each agency’s capacity to ensure that patients have timely access to safe and effective medicines. As of October 2021, the Access consortium had approved 12 submissions through the pathway.
The regulatory authorities involved are:
- Therapeutic Goods Administration, Australia
- Health Canada
- Health Sciences Authority, Singapore
- Swissmedic, Switzerland
- Medicines and Healthcare products Regulatory Agency, United Kingdom
How to get Access
Access work-sharing initiative is suitable for all therapeutic areas. It can be filed under either standard or priority review pathway, but the status must be the same throughout all jurisdictions. Mixing standard and priority is not allowed. A joint review under the New Active Substance Work-Sharing Initiative (NASWSI) may be considered for a new chemical entity, a new biological entity or a new indication. There are two further authorisation procedures available: the Biosimilar Work Sharing Initiative and the Generic Medicine Work Sharing Initiative.
The Access Consortium NASWSI Operational Procedures was published in June 2021 and outlines the planning and implementation of the collaborative submission. The formal work-sharing procedure starts upon submission of an Expression of Interest (EoI) at least 3 months in advance of their anticipated filing date to each agency.
Interested applicants should contact their regional regulatory authority. The application must be submitted to each participating regulator simultaneously, ideally within 15 calendar days. Applications should contain filing information and be submitted to at least two of the Access agencies. It is preferable that the same dossiers are submitted to all the participating regulators, however modules 2-5 can differ. Any differences in the application should be outlined and provided to all regulators as it can impact whether the application is suitable for the work sharing initiative.
To make the process more efficient, a joint pre-submission meeting is recommended. During this meeting a consolidated roadmap for the review cycle is prepared, including timelines for questions and the proposed decision date. The participating regulators then negotiate how to allocate the shared assessment workload (i.e., Quality Assessment, Toxicology Evaluation and Clinical Evaluation) between them. Each regulator evaluates its assigned module(s) and any country specific aspects, discuss issues, and share the outcomes with the other regulators throughout the evaluation period.
Under priority review, the questions from the authorities are ‘rolling questions’ throughout the evaluation period. Whereas, under the standard pathway, questions are often consolidated and sent to the applicant at the same time. The timeframe in which a response is required depends on the lead evaluator of that module. The dossier must be updated in all jurisdictions to ensure that the application is complete. Subsequently, the responses are assessed by each lead evaluator.
The work-sharing normally concludes at the end of the evaluation phase as the process enters the national steps. Different laws and frameworks exist in each country which affects regulatory decisions related to product labelling, packaging material and further down the line, reimbursement issues. Even though the workload is shared, all the involved agencies maintain their authority to take independent decisions according to their country specific quality and safety standards.
What are the benefits of Access work sharing?
Global regulatory partnerships provide a faster patient access to new therapies with a high medical need across multiple countries. According to a survey made by Innovative Medicines Canada in June 2021, pharmaceutical companies stated that their participation in a NASWSI review was motivated by the prospect of consolidated questions for multiple markets and the possibility of shorter review time. A collaborative assessment over several jurisdictions holds many benefits, the most obvious being the opportunity to have access to global markets through one simultaneous evaluation process.
While the potential reduced review timeline through the Access work-sharing is advantageous, the initiative is aiming for greater coordination and alignment across the review and reimbursement system to capture the full benefits from the program. According to their 2021-2024 Strategic Plan, this would involve closer collaboration and engagement with health technology assessment agencies and public drug plans to allow faster access for better patient outcomes.
Filing through Access Consortium is a great opportunity; however, it does place significant demands on the company while navigating the process. Timelines are shorter and multiple agency interactions must be handled in parallel. This calls for a well-established project management with enough capacity, either in-house or through subcontractors. It is necessary to have early interactions with the regulators to find out exactly what is expected for a coordinated filing under tight timelines. Bear in mind that for each jurisdiction there are unique national requirements that demands local regulatory knowledge.
Having the opportunity to place your medicinal product on multiple markets at once, is demanding but well worth the commitment. Remember, that experience and support are at hand.
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