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 initiative aims to:
The OPEN initiative relies on permanent confidentiality arrangements between EMA and medicine regulators outside the EU, who are known as OPEN partners.
These formal arrangements make it possible to exchange information and alow 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.
A list of OPEN partners is available below with information on their confidentiality arrangements with EMA:
| OPEN partner | Information on confidentiality arrangement |
|---|---|
| Therapeutic Goods Administration (TGA) | Australia |
| Brazilian Health Regulatory Agency (ANVISA) | Brazil |
| Health Canada (HC) | Canada |
| Japan Ministry of Health, Labour and Welfare/Pharmaceuticals and Medical Devices Agency (MHLW/PMDA) | Japan |
| Swiss Agency for Therapeutic Product (Swissmedic) | Switzerland |
| World Health Organization (WHO) | World Health Organization (WHO) |
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:
EMA extended the scope of OPEN in June 2023 based on a review of the pilot's first year, to cover medicines:
For more information: