MHRA: NASWSI BSWSI Application Process Outlined

• The MHRA operates New Active Substance Work Sharing Initiative (NASWSI) and Biosimilar Work Sharing Initiative (BSWSI) with Access Consortium partners.
• These initiatives aim to coordinate regulatory reviews and accelerate patient access to new medicines and biosimilars.
• The application process begins with an Expression of Interest (EOI) form submitted 3-6 months before the target dossier submission.
• Applicants must submit largely identical dossiers in eCTD format, adhering to UK regulatory requirements, ideally within two weeks to all participating authorities.
• Regulatory authorities collaboratively review, peer-review, and consolidate findings, though product labelling remains a national determination.

Lawyers advising pharmaceutical companies on new drug or biosimilar market entry in the UK should familiarize themselves with these procedures, including the EOI submission, comprehensive dossier requirements, and the intricacies of the collaborative review process.

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) operates two significant programs designed to streamline the assessment of new pharmaceutical products: the New Active Substance Work Sharing Initiative (NASWSI) and the Biosimilar Work Sharing Initiative (BSWSI). These initiatives represent a collaborative effort with international partners within the Access Consortium, aiming to coordinate regulatory review procedures across multiple jurisdictions. By fostering strong relationships and cooperation, the MHRA and its partners enhance their collective capacity, ultimately facilitating timely patient access to high-quality, safe, and effective therapeutic products.

The NASWSI has already demonstrated considerable success, leading to the approval of numerous medicines. Notable examples include Ocrevus (ocrelizumab), Dupixent (dupilumab), Ekterly (sebetralstat), Lynkuet (elinzanetant), Nemluvio, Opsumit (macitentan), Fruzaqla (fruquintinib), Vabysmo (faricimab), and Brukinsa (zanubrutinib). Building upon this established framework, the Biosimilar Work Sharing Initiative UK extends similar benefits to biosimilar products, leveraging the proven efficacy of the work-sharing model. Detailed operational procedures for the MHRA New Active Substance Work Sharing Initiative are available in a comprehensive 13-page PDF document, providing further guidance on this collaborative process.

Pharmaceutical companies seeking to leverage these work-sharing initiatives must navigate a structured application process. The initial step involves submitting an Expression of Interest (EOI) form to the relevant authorities. Separate forms are provided for new active substances (NAS EOI form) and biosimilars (Biosimilar Expression of Interest form). This crucial preliminary submission should occur between three and six months prior to the applicant's intended target submission date for the full dossier.

Following the EOI, applicants are required to submit largely identical dossiers to all participating regulatory authorities within the work-sharing initiative. While country-specific considerations can be accommodated, the goal is consistency, with submissions ideally occurring within a two-week window. For applications directed to the MHRA, adherence to UK eCTD regulatory requirements is mandatory, ensuring the electronic Common Technical Document format is correctly utilized. Although modules 2 through 5 of the dossier do not strictly need to be identical across all countries, submitting the same information to every participating regulator is preferred. Should any differences exist, a "Summary of differences between dossiers" section, integrated into the EOI form, must be thoroughly completed, outlining all variations in the information provided to each regulatory body.

The core of the work-sharing initiative lies in its collaborative review mechanism. Each participating authority is assigned specific modules or sections of the dossier for its primary review. Once the initial evaluation of all allocated modules is complete, the respective evaluation reports are securely exchanged among the agencies via a dedicated IT platform. This is followed by a critical peer-review phase, where authorities not involved in the initial main review of a particular module then scrutinize those evaluations.

Subsequently, all participating authorities convene via teleconference to discuss their findings and reconcile any discrepancies. This collaborative discussion culminates in the preparation of a consolidated response, which is then communicated back to the applicant. It is important to note that while discussions among regulators regarding product labelling may occur during the assessment phase, the joint review process explicitly excludes product labelling. Final decisions and reviews concerning product labelling remain the prerogative of individual national regulators, determined on a country-by-country basis.

For pharmaceutical companies, understanding the MHRA NASWSI BSWSI application process is paramount for strategic market entry in the UK and other Access Consortium countries. These initiatives offer a pathway to potentially expedite product approvals by leveraging shared regulatory expertise and reducing redundant reviews across multiple jurisdictions. Lawyers advising pharmaceutical companies on new drug or biosimilar market entry in the UK should familiarize themselves with these procedures, including the EOI submission, comprehensive dossier requirements, and the intricacies of the collaborative review process. This strategic planning can significantly influence the timeline and success of regulatory submissions, ultimately impacting patient access to innovative therapies.

Lawyers advising pharmaceutical companies on new drug or biosimilar market entry in the UK should familiarize themselves with the MHRA's NASWSI and BSWSI procedures, including the EOI submission, dossier requirements, and collaborative review process, to strategically plan regulatory submissions and potentially expedite product approvals through international work-sharing.

Source: Original reporting via UK government guidance.