On 3 April we published guidance on our new national assessment procedure for marketing authorisation (MA) applications.

The new guidance is now in effect for MA applications received from 3 April. The guidance applies to both innovative and established medicines, and sets out for the first time how we will deliver decisions on MA applications within the day 210 target to support timely access to medicines, whilst being transparent, predictable and reliable. We encourage engagement before submission to improve the quality of MA applications, so that an earlier decision is possible.

We are holding a webinar on Tuesday 6 May 2025 to provide an overview of the guidance and highlight the key process changes. We will also provide a performance update and cover best practice for application submissions. There will be the opportunity for attendees to submit questions during the question and answer session at the end of the webinar.

To review the guidance, visit National assessment procedure for medicines

To register for the webinar, visit MHRA Licensing – National assessment procedure for medicines webinar Tickets, Tue 6 May 2025 at 10:00 | Eventbrite