Snapshot

The Opening procedures at EMA to non-EU authorities (OPEN) initiative pathway has been developed by the European Medicines Agency (EMA) of EU-EMA.

This pathway can be used where EMA piloted the OPEN initiative during the Coronavirus disease (COVID-19) public health emergency, to support international collaboration in the evaluation and supervision of COVID-19 medicines. The World Health Organization (WHO) took part in the pilot, which contributed to protecting public health across the world, by: supporting the WHO Emergency Use Listing Procedure for COVID-19 vaccines and therapeutics; and facilitating accelerated registration of COVID-19 vaccines and therapeutics in low- and middle-income countries. EMA extended the scope of OPEN in June 2023 based on a review of the pilot's first year, to cover medicines: intended to help combat Antimicrobial resistance; designated under the PRIME: priority medicines scheme (temporarily excluding advanced therapy medicinal products), and other products that address a high unmet medical need (e.g. RSV, Alzheimer's, etc.) (temporarily not including ATMPs products); and vaccines or therapies intended to address public health threats and public health emergencies..

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

Regional regulatory initiatives can help optimize the efficient use of an agency’s resources. The following countries participate in this initiative/pathway: Australia Brazil Canada EU-EMA Japan South Korea Switzerland WHO

Target time assessment is For marketing authorization applications (MAA) and quality variations, applicants can request for their product to be part of the OPEN Framework provided that the application is submitted ≤ 1 month of EMA submission in at least one “OPEN partner”. When submitting the “Letter of Intent Request” through the EMA service desk, applicants will have to specify in the pre-submission request form if they want their application to be reviewed under the OPEN Framework and which OPEN partner(s) will review the application in parallel. The applicant/MAHs is expected to ensure their proposed OPEN partner(s) agree with participating in the procedure prior to submitting the “Letter of intent request” via the EMA service desk. EMA can also facilitate engagement with OPEN partners at applicants/MAHs’ request. For Extensions of marketing authorisations and EoIs, the MAHs should contact the product lead and cc the dedicated OPEN mailbox (OPEN@ema.europa.eu) . EMA may decline including a submission in the OPEN Framework. Applicants/MAHs are advised to consult their company country leads internally to confirm their willingness to file in respective OPEN partner jurisdictions before signalling their interest (e.g. through the Letter of Intent request) to the EMA. OPEN partner should follow the EMA’s assessment timetable (e.g. responses to the List of Questions/List of Outstanding Issues/Request for Supplementary Information to be submitted at the same time to EMA and the OPEN partners). Each OPEN partner will conduct its assessment in parallel and appoint individuals considered as ‘OPEN experts’. OPEN experts are invited to comment during the assessment of the application as any other EU member state (MS). OPEN experts should be able to present the compiled scientific evaluation and overall assessment of their authority. The experts can also discuss and report back within their authority (e.g. to their product team) on the discussions taking place at EMA. WHO may only nominate WHO staff as experts. WHO may also nominate other non-EU regulators as observers. These observers can provide their comments on the application (via the nominated WHO staff expert) and attend any EMA scientific committee discussions (without intervening, just as observers)..