Module 18 - Drug Device Combinations and Other Technologies

30/11/2023

Accelerated Assessment

Offers an accelerated 150 day review process Need to contact MHRA prior to submission and a pre-submission meeting is recommended UK PIP compliance check should be completed 60 days before the intended submission Process: • Assessment phase I = 80 days (inc. orphan assessment if applicable)

• Clock-stop for responses to RFI (60 days) • Assessment phase II = decision by day 150

The Organisation for Professionals in Regulatory Affairs

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Rolling Review

Intended to support the development of novel medicines (new active substances/biologicals, inc. biosimilars) Pre-submission meeting with MHRA required to discuss the product, target population and data expectations CTD modules 3-5 can be submitted separately or together. Each module will be assessed within 60 days and feedback will be provided to enable the applicant to update the module for inclusion in the final phase. Final phase pre-submission meeting recommended – 90 days before submission. Final phase duration = 100 days (60 + 40 with clock-off period)

The Organisation for Professionals in Regulatory Affairs

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