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This Regulation applies to inspections relating to:

a) clinical trials in the EU, including the clinical trial sites in connection with these tests, but outside of the Union;

b) clinical trials mentioned in the requests for clinical trial authorization in accordance with Article 25, 5 paragraph of Regulation (EU) Noo 536 / 2014; c) clinical trials conducted in third countries and mentioned in the marketing authorization application in the EU.

Regulations European Commission 2017 / 556 Inspection Procedures for Good Clinical Practice

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Commit to share
Transmit and progress together
Promoting innovation

The A3P Association is a major player in the pharmaceutical and biotechnology industry.
Created in 1986, it contributes to the good development of the production of medicines and clean and sterile equipment, it runs a network of professionals 21 000, manufacturers and suppliers, as part of International Congress and technical days.

It now has over 1700 members who share their technical experience, scientific and regulatory.

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