EMA starts full medical literature monitoring service

Published: 15-Sep-2015
Regulatory

Will assess literature for 400 active substance groups


The European Medicines Agency (EMA) launched a full medical literature monitoring service on 1 September, with officials looking for reports of adverse reactions to approved medicines on sale within the European Union (EU).

EMA will assess literature for 400 active substance groups (300 chemical and 100 herbal), saying that the service will benefit more than 4,000 companies.

An EMA note said pharmaceutical companies 'are advised to consult the list to check whether their products are covered by the service'. If so, they will no longer be obliged to enter information from literature on suspected adverse reactions into the EU pharmacovigilance database EudraVigilance.

'Individual cases of suspected adverse reactions found in the literature will be made available to marketing-authorisation holders so they can include them in their safety databases,' the regulator added.

  • Companies:
  • EMA European Medicines Agency
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