Intended for healthcare professionals

Letters Opening up data at the EMA

EMA’s response to articles

BMJ 2011; 342 doi: https://doi.org/10.1136/bmj.d3838 (Published 20 June 2011) Cite this as: BMJ 2011;342:d3838
  1. Andreas Pott, acting executive director1
  1. 1European Medicines Agency, London E14 4HB, UK
  1. press{at}ema.europa.eu

Two recent BMJ articles have given the European Medicines Agency (EMA) useful feedback from the academic community on its provision of information on the scientific review of medicines.1 2 The agency is grateful for and open to suggestions on how this can be improved.

The authors of both articles ignore recent steps that the agency has taken to improve the transparency and presentation of this information.

The agency’s new policy on access to documents,3 which became effective in November 2010, has pushed transparency further forward than in most other drug regulatory authorities. It grants wider access than ever before to documents originated, received, or held by the agency, including clinical trial reports submitted as part of marketing-authorisation applications. There will be a move towards proactive publication of more of these documents over the next few years.

The presentation of information in the European Public Assessment Report (EPAR) has also been improved. The EPAR summarises the scientific conclusions reached at the end of the centralised evaluation process, and it allows researchers to identify which published and unpublished studies were evaluated in the authorisation process. Full clinical trial reports of these studies can be released on request, in line with the agency’s new access to documents policy.

At the end of 2010, the agency responded to requests from its stakeholders by introducing a new tabular format for the presentation of relevant results from clinical studies (including number of randomised patients per treatment arm, results per intention to treat and per protocol, number of patients analysed for primary outcomes, efficacy results, and size) assessed in the support of new marketing-authorisation applications.

Further improvement of the EPAR, specifically information on the assessment of the benefit-risk balance, is one of the key priorities in the agency’s Road map to 2015.4

Notes

Cite this as: BMJ 2011;342:d3838

Footnotes

  • Competing interests: None declared.

References

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