International Competent Authorities

As cellular therapy products often cross international borders, it is important to be aware of applicable regulations in other regions. Products shipped across international borders must meet regulatory requirements of the competent authority of the exporting and importing country. Information on some non-U.S. competent authorities can be accessed via the links provided below. The information for each country is meant to serve as a resource, not a substitute for regulatory information or legal advice. Additionally, the information on this page is not updated in real-time, please contact the relevant competent authority to receive the most up-to-date information.

Argentina

Argentina

Australia

Australia

Brazil

Brazil

Canada

Canada

China

China

Colombia

Colombia

European Union

European Union

Greece

Greece
Ministry of Health

Hong Kong

Hong Kong

India

India

Israel

Israel
Ministry of Health, Medical Technologies and Infrastructure Administration

Italy

Italy
Ministry of Health
The Italian Medicines Agency (AIFA)

Japan

Japan

Malaysia

Malaysia

Mexico

Mexico

Poland

Poland
Ministry of Health

Portugal

Portugal
National Authority of Medicines and Health Products (INFARMED)
INFARMED – English Language Web Pages

Saudi Arabia

Saudi Arabia

Singapore

Singapore

South Africa

South Africa

South Korea

South Korea

Taiwan

Province of Taiwan

Thailand

Thailand
Food and Drug Administration

United Kingdom

United Kingdom
Human Tissue Authority (HTA)
Medicines and Healthcare Products Regulatory Agency (MHRA)