Rolling Review for Marketing Authorisation Applications in the UK

What is the Rolling Review?

The rolling review is a regulatory route for marketing authorisation applications (MAAs) in the UK whereby an applicant can submit modules of the electronic Common Technical Document (eCTD) dossier incrementally for pre-assessment by the Medicines and Healthcare products Regulatory Agency (MHRA) rather than waiting to compile and submit a full consolidated application at once.
Source: Rolling review for marketing authorisation applications (gov.uk)

This approach is intended to streamline the development of novel medicines by enabling earlier regulatory interaction, identifying issues sooner, and reducing the risk of failure in late stages of the process. It may be integrated with a Target Development Profile (TDP) to give applicants a clearer pathway for successful development.
Source: Rolling review for marketing authorisation applications (gov.uk)

Eligibility and Scope

The rolling review can be used for:

• New Active Substances (NAS) where a “full dossier” is required; and
• Similar biological medicinal products (biosimilars).
  Source: Rolling review for marketing authorisation applications (gov.uk)

Supporting data requirements for NAS and biosimilars remain those set out in the relevant provisions of the Human Medicines Regulations (e.g., regulation 50(5) for NAS) and corresponding biosimilar regulations.
Source: Rolling review for marketing authorisation applications (gov.uk)

How Rolling Review Works

Under the rolling review route:

1. Applicants submit dossier modules (quality, safety, efficacy sections) of the eCTD separately as they become ready.
2. The MHRA reviews these modules as they arrive, providing feedback and early assessment.
3. This incremental pre-assessment allows identification and resolution of issues earlier than in a traditional single submission.
4. Once all modules are submitted and pre-assessed, a consolidated evaluation follows toward a final marketing authorisation decision.
   Source: Rolling review for marketing authorisation applications (gov.uk)

Integration With Development Strategy

The rolling review may be used in combination with a Target Development Profile (TDP)—a planning aid that outlines critical development milestones and data requirements. Using rolling review alongside a TDP may help clarify regulatory expectations early and support smoother progression through the application lifecycle.
Source: Rolling review for marketing authorisation applications (gov.uk)

Geographic Applicability

Until the Windsor Framework is implemented on 1 January 2025, rolling review applications can only be submitted for applications intended for Great Britain (England, Scotland, and Wales). After that date, the MHRA will license new active substances and biosimilars UK-wide, and the rolling review process will similarly be available across the whole UK.
Source: Rolling review for marketing authorisation applications (gov.uk)

Benefits of Using Rolling Review

• Enhanced regulatory engagement: Frequent interactions with the MHRA during dossier development can clarify data expectations and reduce the likelihood of major deficiencies later.
• Flexible submission: Data can be submitted as ready rather than waiting to assemble a complete dossier.
• Potential reduction in time to market: Early reviews of key sections may help accelerate final evaluation once the whole dossier is submitted.
  Source: Rolling review for marketing authorisation applications (gov.uk)

Practical Considerations

Applicants should plan the sequencing of module submissions carefully to align with data availability and regulatory timelines. Engagement with MHRA early in development—including pre-submission meetings—can help optimize the rolling review strategy.
Source: Rolling review for marketing authorisation applications (gov.uk)

Conclusion

The rolling review provides a structured, iterative pathway for submitting marketing authorisation applications in the UK that can enhance early regulatory dialogue, improve dossier quality, and support efficient assessment of innovative and complex medicinal products.
Source: Rolling review for marketing authorisation applications (gov.uk)