A key part of our job as medicines regulators is to focus on public health in our own country and region. Increasingly though, health and medicine regulation is a cross-border concern and, therefore, we need to think and act not only locally, but also globally. Regardless of whether you are a big or small regulator, we know that collaboration and reliance are more important than ever. They also help support regulatory harmonisation, capacity building, transparency and trust. EMA collaborates with medicine regulators outside the EU in the scientific evaluation of certain medicines under a framework called ‘Opening Procedures at EMA to Non-EU Authorities’ (#OPEN). With OPEN, several regulators can evaluate a medicine in parallel with EMA, remaining scientifically and procedurally independent from one another while sharing information, expertise, and approaches during the evaluation process. This sort of collaborative approach requires alignment of dossiers and submissions to improve regulatory convergence. Importantly, it can also result in earlier access and potentially faster global approvals through leveraging existing or ongoing assessments and expertise beyond the EU regulatory network, leading to fewer questions for industry and labelling differences. The recent EMA green-light assessment of a #Chikungunya vaccine working together with both WHO and the Brazilian regulator ANVISA is the latest example. Applicants can ask for review under OPEN for products covered by the scope of the pathway: #AMR, #PRIME, high unmet medical needs and medicines responding to health threats or public health emergencies. Begun in December 2020 to increase international collaboration and share scientific expertise on the evaluation of #COVID19 vaccines and therapeutics, the OPEN pathway allows non-EU regulators to conduct near-concurrent reviews of certain new medicines and exchange their views and reports on the assessment of the medicine. Experts from our OPEN partners participate in the Agency’s assessment in the same way as our committee members, except for the final decision making, when each regulatory authority maintains its independence. Our partners are: 🌏 Australia: Therapeutic Goods Administration (TGA) 🌎 Brazil: Brazilian Health Regulatory Agency (ANVISA) 🌎 Canada: Health Canada | Santé Canada (HC) 🌏 Japan: Ministry of Health, Labour and Welfare/Pharmaceuticals and Medical Devices Agency (MHLW/PMDA) 🌏 Republic of Korea: Ministry of Food and Drug Safety of Republic of Korea (MFDS) 🌍 Switzerland: Swiss Agency for Therapeutic Product (Swissmedic) 🌐 World Health Organization (WHO) This is an exciting pathway that has already shown impact. EMA recently changed the process in response to industry requests to be able to apply for their product to go into OPEN, and full details of the revisions can be found in our updated Q&A document: https://europa.eu/!RNbnQh [A guest post by Martin Harvey Allchurch]
This is an absolutely brilliant initiative, once again showing the leadership position and thinking of all at EMA.
A great initiative for cross border collaborations - putting patients first!
Excellent and an important step forward towards the path of harmonisation. This will also pave the way for expedited review of critical new therapies and will benefit patients!
Thank you Martin for this guest post and for all the fantastic collaborative work you and your team in the International Affairs office at EMA do! Really great to see the feedback from industry being taken into account and an updated Q&A being published today 👏
Great to see this important initiative going from strength to strength and hoping that more partners will be able to join in the future - with thanks to the International Affairs office for the amazing work being done !
Very informative
Great initiative, thank you for sharing here Martin Harvey Allchurch. Are there any plans to follow this path also for veterinary medicines?
I agree!
Insightful!
Head of Regulatory Affairs Asia Pacific
1moThe EMA's #OPEN framework is a great example of global collaboration in medicine regulation. Please include more competent authorities! This approach strengthens regulatory harmonization and supports better health outcomes globally.