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 Organisation (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; and medicines 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 Switzerland WHO

Once a product has been selected to be assessed under the OPEN framework, the EMA product team will include experts from OPEN partners in the assessment procedure to ensure that comments will be received. The experts can also discuss and report back within their authority (e.g., to their product team) on the discussions taking place at EMA. EMA rapporteurs may contact OPEN experts when required. OPEN experts will receive the Rapporteur’s assessment reports (AR) and the list of questions (LoQs) from the applicant/MAH; applicants/MAHs will be asked to do this in a timely manner. They are then expected to review the documents and provide written comments on documents within the same time frame as other members. OPEN partners will also actively share their preliminary and final reports, list of questions, applicant responses and any divergent analysis with the EMA. EMA rapporteurs and OPEN experts can request additional meetings for discussion. Open experts’ comments will be addressed during the assessment as any other EU experts’ comment. OPEN experts are not permitted to contribute to the Committee’s conclusions (or voting) on any key procedural milestone, in particular the adoption of opinions. They can still listen to these opinionmaking steps, but are not allowed to contribute. There is no obligation to align opinions, approvals or policies. Participation of OPEN partners should not limit or constrain the independence of the EMA scientific assessment. The participating authorities will retain their independence as well.