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Delays in access to EMA documents: the Agency confers with Prescrire

A video conference was held between the European Medicines Agency (EMA) and Prescrire to discuss the delays in dealing with Prescrire's requests for access to documents.

On 6 September 2021, following an invitation by Emer Cooke, executive director of the European Medicines Agency (EMA), a video conference took place between the EMA and Prescrire to discuss access to Agency documents.

This virtual meeting followed two exchanges of correspondence (in December 2020 and June 2021) concerning the EMA's slow response to requests for access to documents necessary for Prescrire's work, particularly drug packaging mock-ups.

During its contribution, Prescrire highlighted three problem areas:

  • unacceptable delays in processing of requests for access to documents, caused mainly by the queuing system;
  • censorship, i.e. redaction, of some, mainly clinical, data in Agency documents; 
  • revealing Prescrire's identity to the market authorisation holder concerned.

Prescrire also suggested some ways forward, and will continue to objectively assess progress in the Agency's transparency based on its requests for documents.

©Prescrire 1 July 2022

Source: "Access to EMA documents" Prescrire International 2022; 31 (239): 194. Subscribers only.

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For more information:

"European Medicines Agency:
transparency policy marred
by too many failings"
Prescrire Int 2022;
31 (237): 131-139.
Pdf, free

"The EMA is withholding
too much information"
(May 2022)

"European Medicines Agency:
insufficient transparency” 
(May 2022)

"Transparent, independent
health authorities”
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