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The evolution of pharmacovigilance regulation at European level has led to significant changes in the electronic transmission of individual case safety reports (ICSRs) among the various actors in order to:

- rationalize the exchange of information,
- to ensure better monitoring of the safety of use of medicinal products,
- enrich the content of the exchanged data.

It is in this context that new features of EudraVigilance will be implemented by the EMA from 22 November 2017.

In this respect, a new guide for the electronic transmission of individual observations of adverse effects (ICSRs) is available on our website.

Information for pharmaceutical companies concerning the electronic transmission of individual pharmacovigilance observations

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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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