Changes to Marketing Authorisation Applications for Established Medicines in the UK

Overview of Process Changes

From 1 March 2024, the Medicines and Healthcare products Regulatory Agency (MHRA) has introduced new procedural changes for marketing authorisation applications (MAAs) relating to established medicines in the UK. These changes are designed to improve the efficiency and clarity of application handling and to ensure applications are complete and ready for assessment when submitted.
Source: Established medicines: marketing authorisation application changes (gov.uk) (gov.uk)

The term “established medicines” generally covers chemical products that are not new active substances and excludes biosimilars. Line extensions to new active substances are also within scope for these procedural updates.
Source: Established medicines: marketing authorisation application changes (gov.uk) (gov.uk)

Revised Application Handling

1. New Submissions Where Assessment Has Not Started

Under the new process, the MHRA will not begin assessment of incomplete applications. Applicants must ensure submissions are complete at the point of filing, reducing delays and limiting the need for multiple clarification cycles.
Source: Established medicines: marketing authorisation application changes (gov.uk) (gov.uk)

The guidance also emphasises the importance of right-first-time submissions, with tools such as checklists to support applicants in preparing their dossiers according to MHRA expectations.
Source: Apply for a licence to market a medicine in the UK (gov.uk) (gov.uk)

2. Applications Under Assessment or with a Request for Further Information

For applications already under assessment or where the MHRA has issued a Request for Further Information (RFI), revised procedures aim to streamline communication between the applicant and the regulator. Under the updated approach, the MHRA may limit the number of RFIs issued, focusing on essential clarifications to move the application forward efficiently.
Source: Established medicines: marketing authorisation application changes (gov.uk) (gov.uk)

Public Assessment Reports (UKPAR)

In line with the process changes, the MHRA continues to publish UK Public Assessment Reports (UKPAR) that summarise the scientific assessment of authorised medicines. These reports help increase transparency about regulatory decisions and the rationale for approvals or requests for additional data.
Source: Established medicines: marketing authorisation application changes (gov.uk) (gov.uk)

Practical Implications for Applicants

• Preparation is key: Applicants should use the available checklists and preparatory tools to ensure dossiers are complete before submission.
• Minimising delays: By not processing incomplete applications and limiting multiple requests for information, the MHRA aims to reduce assessment timelines.
• Clarity in communication: Structured interaction between applicants and assessors aims to reduce ambiguity in scientific or regulatory questions.
  Source: Established medicines: marketing authorisation application changes (gov.uk) (gov.uk)

Context in the UK Regulatory System

These changes fit within the broader UK post-Brexit regulatory framework managed by the MHRA, which continues to adjust procedures to ensure robust and efficient assessment of medicinal products across the UK.
Source: Marketing Authorisation Application (Wikipedia)

Conclusion

The established medicines marketing authorisation application process changes reflect the UK regulator’s efforts to streamline submissions, ensure completeness at the outset, and improve the overall predictability of the evaluation process—benefiting both applicants and public health stakeholders.
Source: Established medicines: marketing authorisation application changes (gov.uk) (gov.uk)