EMA Board Adopts New Policy on Whistleblowing

In order to encourage complainants and others to feel secure with possible details of the irregularities, the European Medicines Agency's (EMA) Board of Directors adopted a new policy on Monday detailing how the agency handles allegations , Including those that could have an impact on drug evaluation and monitoring.

Since 2013, EMA says it received a total of 43 of these reports detailing various issues and allegations of drug manufacture in conducting clinical trials.

"While there is no formal policy so far, all reports have been treated in accordance with the principles of the new policy," said EMA, noting that this new policy will help EMA to evaluate all reports and coordinate any further investigation In a structured manner, while protecting the journalist's confidentiality.

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Any external entity aware of facts that may have an unequal impact on the authorization, supervision and maintenance of human and veterinary medicines may, in the public interest, be reported to EMA at the following address: @ ema.europa.eu reports .

The BMA says that it will ensure the confidentiality of information from outside sources and the identity of the sources and the protection of personal data, these data lead to a later review by the EMA or the Anti-Fraud Office (OLAF) or do not.

"Examples of claims that can be made to understand that the integrity of the data in the studies used to support the marketing authorization can not be invoked.That integrity is essential to confidence in authorized drugs.These problems can occur due to To the formation of poverty, inadequate application of procedures and controls or even falsification of data, "says the policy.

"If there is a fear that irregularities may affect the balance of drug benefits and risks, EMA's scientific committees may consider regulatory action," the agency said in a statement. If the allegations relate to a drug EMA throughout the authorized country, it may, on a case-by-case basis, refer the matter to the national drug agency of that Member State.

The policy, which came into force on 17 March 2017 and prepared in consultation with the European Commission and OLAF, will be reviewed in three years.