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).

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.

Participating organisations

The OPEN framework relies on permanent confidentiality 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)

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

OPEN partners may attend and contribute to meetings of EMAs Committee for Medicinal Products for Human Use (CHMP) and Emergency Task Force (ETF).

EMA and OPEN partners remain scientifically and procedurally independent throughout.

For more information on these formal arrangements, see:

• Australia
• Brazil
• Canada
• Japan
• Republic of Korea
• Switzerland
• World Health Organization (WHO)

Scope and 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. This was in order 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;
• intended to address Public health threats and public health emergencies.

Guidance is available for applicants on how to request the review of their products under the OPEN framework, starting with July 2024.

This process includes naming the OPEN partners who will review the application in parallel with EMA.

For more information, see:

Questions and Answers on the 'OPEN' Framework

Reference Number: EMA/55338/2023

OPEN Pilot: One-year review and recommendations

Reference Number: EMA/6881/2022