Snapshot

The EMA initiatives for acceleration of development support and evaluation procedures for COVID-19 treatments and vaccines pathway has been developed by the European Medicines Agency of EU-EMA.

This pathway can be used where Treatments and vaccines for COVID-19..

This pathway facilitates activities during development.

It is an abridged review (a reliance pathway).

SCIENTIFIC ADVICE: The key features of scientific advice for medicines targeting COVID-19 are the following: (i) There are no pre-specified submission deadlines for developers to submit their submission dossier; (ii) There is flexibility regarding the type and extent of the briefing dossier, which needs to be discussed on a case-by-case basis; (iii) This scientific advice is free of charge in accordance with Regulation (EU) 2022/123 and the EMA Executive Director Decision (EMA/534263/2021); and (iv) Where scientific advice is accelerated, the total review time from the start to the final advice letter is reduced to 20 days, compared to the regular 40/70 days time frame. This is achieved through accelerating all milestone stages of the process (assessment report circulation, peer review, adoption). In addition to the formal assessment procedure, also the validation process preceding it is accelerated. Depending on the nature of the request the timelines could be shortened even further. ROLLING REVIEWS: Furthermore, rolling reviews can be used by the EMA for products that are of strategic importance in the context of the pandemic, for which the proof of concept has been established based on clinical data, no blocking issues have been identified, and the dossier and manufacturing plans are sufficiently mature so that application for a (conditional) marketing authorisation can be expected no later than within approximately 4 months from the start of rolling review. There can be several Rolling Review cycles with the timelines for assessment and providing questions to the applicant being agreed with Rapporteurs and EMA for each review cycle, based on the contents of the respective submission and the overall time plan for submission of data. Responses to list of questions from previous Rolling Review cycles are ideally to be incorporated into subsequent Rolling Review submissions. While only applications of sufficient maturity are accepted for rolling review, unexpected delays with providing responses to the questions raised or significant delays from the agreed submission schedule may lead to delays in completing the rolling review stage of the application review. Following the rolling review, once the CHMP, based on the advice of the ETF, considers that the data package is sufficiently complete to proceed to formal regulatory submission, submission by the company of the formal marketing authorisation application or extension of indication is expected, which, after validation, will be processed under a shortened timetable. The duration of the procedure will depend on the amount of data not yet assessed as part of rolling review cycles. To plan for such Rolling Review, developers should make the initial contact through the PHEearlysupport@ema.europa.eu mailbox in order to allow review of suitability and maturity of the planned submission for appointment of Rapporteurs for potential rolling review. Once agreed, an EMA product lead will be allocated, who will provide guidance and support throughout the procedure. Should the applicant not wish to use rolling review or in case the application has not been accepted for such review, the applicant may still apply for EMA Accelerated Assessment. In such case, the review of the application is started only after validation of a complete application, but the maximum active review time is reduced from 210 to 150 days, which in practice may even be shorter.