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EMA sets up inbox for pharma whistle-blowers and adopts investigation policy

By Gareth MacDonald+

11-Apr-2017
Last updated on 25-Apr-2017 at 17:08 GMT2017-04-25T17:08:16Z

iStock/Sohel_Parvez_Haque
iStock/Sohel_Parvez_Haque

The EMA has set up an email inbox for drug company employees who report improper manufacturing and trial activities.

The European drug regulator announced the whistle-blower inbox this week along with details of how it will manage and investigate allegations of improper practices provided by drug company employees.

The European Medicines Agency (EMA) said its aim is to “create an environment where individuals from outside the agency fell confident to raise their concerns on improprieties in their area of work” adding that people who do share information will be guaranteed anonymity.

Reports relating to centrally authorised drugs will be investigated by the EMA, while nationally authorised medicines may be referred to authorities in the relevant country.

If any of the information is likely to impact the balance of benefits and risks of the medicine, EMA’s scientific committees may consider regulatory action.

The currently London-based agency said that, in cases where fraud is suspects, if will pass on information to the Brussels-based European Anti-Fraud Office (OLAF). 

Reports

The EMA also revealed it has received 43 reports of improper practices relating to the manufacture and clinical assessment of drugs since 2013.

The agency told us "The majority of the cases related to allegations of improprieties on GMP non-compliance or misconduct during manufacture of medicines and GCP non-compliance or misconduct during clinical trials.

"In 29 out of the 43 cases, the information from the external source was transferred to the relevant competent authorities in the Member States, either to perform the assessment of the information on behalf of the Agency or to handle the case independently because the case did not fall within EMA’s competence."

The agency also pointed out that: "Some of the 43 cases are still ongoing. Information provided by external sources in all 43 cases has been looked at, and so far the Agency has not identified any safety concerns entailing the need to take specific regulatory action, neither in closed nor ongoing cases."

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