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EMA Highlights: WHO and EU link up to boost public health

Written by | 15 Oct 2015 | All Medical News

by Gary Finnegan: EU agencies are stepping up cooperation with the World Health Organization (WHO) to share information on the safety, quality and efficacy of medicines.

The agreement will see the European Commission and European Medicines Agency provide the WHO with “non-public” details of products which are already authorised or under review in the EU. For its part, the WHO is to share data on medicines which are pre-qualified or under review by the WHO.

The cooperation will make it easier and quicker to take action to protect public health, according to an EMA statement. It will also “accelerate patients’ access to new and innovative medicines in the EU, avoid duplication of assessments and improve the authorisation and safety of medicines by involving the best expertise from both sides”, the drug watchdog said.

The arrangement further strengthens collaboration between the WHO, the European Commission and EMA who have a long history of scientific and technical collaboration through the International Conference on Harmonisation and the International Pharmaceutical Regulators Forum.

According to the new agreement which came into force in September, the following data will be shared on a confidential basis:

  • Post-authorisation pharmacovigilance data, particularly related to adverse drug reactions as well as safety concerns arising from periodic safety update reports, and post-authorisation obligations and commitments;
  • Information in applications for scientific advice, orphan medicine designation, marketing authorisation or post-authorisation activities of significant public health interest, and applications for agreement of paediatric investigation plans;
  • Data related to inspections, manufacturing facilities and clinical research activities and related reports.

Meanwhile, in a separate development, the EMA has published summaries and presentations from a series of consultation meetings with academic, industry, patient and other organisations regarding its policy on publishing clinical data.

A number of meetings were held during the summer and early autumn on the controversial topic, along with a webinar to help stakeholders understand the Agency’s new approach to publishing data.

EMA’s policy on publication of clinical data entered into force on 1 January 2015 and applies to clinical reports contained in all marketing-authorisation applications submitted on or after this date. The publication of the first reports is foreseen for mid-2016.


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