Opening procedures at EMA to non-EU authorities (OPEN) framework

The European Medicines Agency (EMA) collaborates with medicine regulators outside the European Union (EU) in the scientific evaluation of certain medicines, within a framework called OPEN (opening procedures at EMA to non-EU authorities).

Updated on 20 January 2026:
-to update the document 'Questions and Answers on the 'OPEN' Framework'.

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.

The OPEN framework aims to:

• make it possible to share expertise and tackle common challenges;
• help harmonise regulatory approaches in different regions;
• speed up patient access to innovative medicines;
• increase the transparency of regulatory decision-making.

For more information, see:

• Multilateral coalitions and initiatives

Participating organisations

The OPEN framework relies on permanent arrangements between EMA and medicine regulators outside the EU, who are known as OPEN partners.

The world map visual below shows the location of all OPEN partners.

World map - Open partners

World map - OPEN partners: Text version

Australia - Therapeutic Goods Administration (TGA)

Brazil - Brazilian Health Regulatory Agency (ANVISA)

Canada - Health Canada (HC)

Japan - Japan Ministry of Health, Labour and Welfare/Pharmaceuticals and Medical Devices Agency (MHLW/PMDA)

Republic of Korea - Ministry of Food and Drug Safety (MFDS)

Switzerland - Swiss Agency for Therapeutic Product (Swissmedic)

World Health Organization (WHO)

These arrangements make it possible to exchange information and allow participation in EMA's scientific evaluations.

EMA and OPEN partners remain scientifically and procedurally independent throughout.

For more information on these formal arrangements, see:

• International agreements

Scope of OPEN

The OPEN framework covers the assessment of medicines:

• intended to help combat antimicrobial resistance and novel antimicrobials;
• designated under the PRIME scheme;
• that address a high unmet medical need;
• intended to address public health threats and public health emergencies, including vaccines.

Guidance for applicants on how to request the review of their products under the OPEN framework is available:

Questions and Answers on the 'OPEN' Framework

Reference Number: EMA/55338/2023

For more information, see:

• Antimicrobial resistance in human medicine
• PRIME: priority medicines

Development of OPEN

EMA piloted the OPEN framework 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;
• facilitating accelerated registration of COVID-19 vaccines and therapeutics in low- and middle-income countries.

EMA extended the scope of OPEN in July 2023 based on a review of the pilot's first year to cover more medicines. Find the document below:

OPEN Pilot: One-year review and recommendations

Reference Number: EMA/6881/2022

For more information, see:

• Coronavirus disease (COVID-19)
• COVID-19 medicines
• Public health threats
• World Health Organization (WHO)
• World Health Organization - Emergency Use Listing