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UK MHRA: Rolling Review for MAA and 150-Day Assessment for National Applications

Earlier today (16 April 2024) Medicines and Healthcare Products Regulatory Agency (MHRA) updated its guidance on "Rolling Review for Marketing Authorization Applications" and yesterday updated the guidance on "150-Day Assessment for National Applications for Medicines".


To streamline this process and ensure timely access to new treatments, regulatory agencies like the UK Medicines and Healthcare products Regulatory Agency (MHRA) have implemented innovative approaches. One such approach is the rolling review for marketing authorization applications.


Rolling Review is a regulatory pathway where an applicant for a marketing authorisation submits modules of the eCTD dossier incrementally for pre-assessment by the MHRA, unlike the traditional marketing authorization application process, where all data must be submitted at once, the rolling review allows for a more flexible and iterative approach. This can significantly reduce the time to market for new treatments.


In order to reduce the risk of failure at the final phase of drug development, the rolling review provides periodic enhanced regulatory interaction and advice to streamline the development of novel drugs. To provide a clearer pathway for innovative medicine development, the Target Development Profile (TDP) may be integrated into the rolling review.


If you would like to use the rolling review you should request a pre-submission meeting to discuss the product, its intended target populations and the data in each module to be submitted. Click this LINK to know more about how to apply, eligibility, and assessment for rolling review.


The 150-day assessment is the period during which the MHRA reviews a national marketing authorization application for a medicine. The MHRA offers a 150-day assessment timeline for all high-quality marketing authorisation applications (MAAs), aiming at accelerating the availability of medicines for patients in the UK.


The guidance mentions about the Key Steps in the Assessment Process

  • Validation: Upon receiving an application, the MHRA conducts an initial validation to ensure that all required information has been provided.

  • Assessment: The MHRA assesses the application to determine whether the medicine meets the required standards of safety, quality, and efficacy.

  • Consultation: The MHRA may consult with other regulatory bodies or experts to gather additional information or seek advice.

  • Decision: At the end of the 150-day assessment period, the MHRA decides on whether to grant marketing authorization for the medicine.

Check out this guidance for more detailed information on 150-day assessment for national applications for medicines.

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