UK MHRA Guidance: Access Consortium’s New Active Substance Work Sharing Initiative (NASWSI)
The Medicines and Healthcare products Regulatory Agency (MHRA) provides information on the Access Consortium’s New Active Substance Work Sharing Initiative (NASWSI), an international regulatory collaboration that coordinates the assessment of new active substance applications across participating regulatory authorities. The initiative aims to strengthen regulatory cooperation, increase assessment capacity and support timely access to high-quality, safe and effective therapeutic products.
The initiative has successfully supported the approval of several medicines through coordinated regulatory reviews. The related Biosimilar Work Sharing Initiative (BSWSI) builds on this collaborative approach.
Assessment Procedure
Applicants interested in participating in NASWSI should first submit a New Active Substance Expression of Interest (EOI) Form to the relevant regulatory authorities. This should be completed approximately 3 to 6 months before the intended submission date.
Following the expression of interest, applicants must submit identical dossiers, taking country-specific requirements into account, to the participating authorities. Where possible, submissions should be made within a two-week timeframe.
Applications submitted to the MHRA must be in eCTD format and comply with UK regulatory requirements. Although Modules 2 to 5 do not have to be identical across countries, submitting the same dossier to all participating regulators is preferred. If differences exist, applicants should complete the “Summary of Differences Between Dossiers” section included in the EOI form.
Joint Regulatory Review Process
Under NASWSI, each participating authority is assigned specific module or modules for the main assessment. Once the main reviews are completed, the evaluation reports are shared through a secure IT platform.
Participating authorities that did not conduct the initial review then peer-review the relevant modules. The regulators subsequently discuss their findings through a teleconference and prepare a consolidated response for the applicant.
This coordinated process enables participating authorities to share assessment work while retaining their individual regulatory responsibilities.
Product Labelling and Regulatory Decisions
Product labelling is not included in the joint review process. Although regulators may discuss labelling during the assessment, each authority reviews and determines the final product labelling at the national level because regulatory and legal requirements may differ between countries.
For applications following the standard review pathway, clarification questions are consolidated and sent simultaneously to all local affiliates. The timing depends on the review milestones agreed by participating regulators. Questions specific to an individual jurisdiction, including labelling-related questions, are sent separately to the relevant local affiliate.
For applications following the priority review pathway, which is applicable only to NASWSI, clarification questions are sent to the respective local affiliate. These questions are also shared with the partner regulator and its local affiliate to support the submission of subsequent eCTD sequences and ensure application completeness across participating authorities.
Regulatory Independence and Approval Decisions
Although NASWSI facilitates a coordinated assessment, each participating regulator maintains its independence when making the final regulatory decision.
An approval or refusal by one authority does not necessarily affect the decision or timing of the remaining participating regulators. The joint review decision date is included in the evaluation timeline and is agreed upon by the participating authorities before being communicated to the applicant.
National procedures continue to apply for publishing external assessment summaries, such as the UK Public Assessment Report (PAR), Australian Public Assessment Report (AusPAR), Canadian Summary Basis of Decision and Swiss Public Assessment Report (SwissPAR).
Fees and Participating Regulatory Authorities
National fees apply to applications submitted through the initiative. The applicable fees vary depending on the type of application, and applicants should refer to the MHRA fees information for further details.
The NASWSI application process involves the following participating regulatory authorities:
United Kingdom – MHRA
Australia – Therapeutic Goods Administration (TGA)
Canada – Health Canada
Singapore – Health Sciences Authority (HSA)
Switzerland – Swissmedic
Interested applicants are invited to contact their regional regulatory authority using the NASWSI Operational Procedures, approximately 3 to 6 months before the planned submission date. Email communications should include “Access Consortium – NASWSI” in the subject line.
Key Takeaway
The Access Consortium’s NASWSI provides a framework for coordinated regulatory assessment of new active substance applications across participating authorities. Through shared dossier reviews, peer review and consolidated applicant responses, the initiative supports regulatory collaboration while preserving national decision-making responsibilities. Applicants planning to participate should initiate contact with the relevant authorities 3 to 6 months before submission and consider the dossier coordination and country-specific requirements.
References
Comments