EMA publishes details of new pharmacovigilance format

pharmafile | July 4, 2011 | News story | Research and Development, Sales and Marketing EMA, pharmacovigilance 

Pharma companies have been given the highly-specific electronic formats in which they will soon have to submit information on medicines authorised or registered in the EU.

The European Medicines Agency has just published the formats, enabling the pharma sector to comply with part of the new EU pharmacovigilance legislation passed last December.

Companies have until 2 July to submit the data to the EMA, which says the information will help it create a list of all medicines authorised and registered in the EU.

Pharma firms will also be responsible for maintaining the information using the EudraVigilance Medicinal Product Report Message (EVPRM) once it is submitted.

The EMA is urging pharma companies to familiarise themselves with their new legal obligations “so that they are prepared for the electronic submission of the information, starting later in the year”.

This extra regulatory requirement is aimed at improving patient safety by improving monitoring, and will also help the regualtor identify medicines included in reports of suspected adverse drug reactions (ADRs) and to co-ordinate its regulation and safety-monitoring activities.

ADRs are estimated to cause 197,000 deaths per year in the EU at present.

A 200-page EMA guidance document contains numerous examples of the sorts of information required.

Companies can either develop their own electronic means to submit data via the EMA’s ‘EudraVigilance Gateway’ or they can use the EMA’s own data entry and submission tools.

The latter are specifically aimed at small and medium sized firms but will be made available to any pharma company if required.

The EMA is also organising face-to-face and online training sessions, starting in the autumn, and is to hold half a dozen stakeholder workshops before July next year, at which patients and doctors will express their views on the implementation of the legislation.

Adam Hill

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