The European Council has formally approved new European drug safety legislation, which member states will have until the end of 2013 to implement.
The changes, which were officially passed last week, were prompted by the 2011 scandal of Servier’s Mediator, which was left on the market even as serious health concerns began to emerge. A French government report subsequently linked the diabetes drug to up to 2,000 deaths, prompting major regulatory changes in the country.
The new Regulation and Directive on Pharmacovigilance will see a number of changes, including the use of standard black symbol – possibly a version of the black triangle already in use in the UK – to alert patients and prescribers to drugs that require closer monitoring.
Other changes the Regulation and Directive on Pharmacovigilance legislation will implement include:
• The introduction of an automatic urgent procedure for review at EU level, if there are serious safety concerns about a medicinal product that is authorised in more than one member state
• Pharma companies will be forced to be more transparent about the reasons for the withdrawal of a medicinal product from the market, so that withdrawal for safety reasons can be easily identified
• An ensurance that drugs whose approval is contingent on post-authorisation safety studies are included on a list of medicines under increased monitoring.
“No product will fall through the net and escape scrutiny where safety concerns are identified,” the European Council said.
Europe’s new pharmacovigilance committee begins first drug safety review
Meanwhile, the EMA’s new pharmacovigilance committee has began its first drug safety review, taking aim at the use of codeine-containing medicines to treat post-operative pain in children.
The review is the first to take place under new EU rules on pharmacoviglance, which gained a legislative footing last week.
At the request of UK regulator the MHRA, the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) will assess concerns about an increased risk of morphine toxicity when the widely used analgesic codeine is given to children after surgery.
A small number of cases have been reported of rare but fatal or life-threatening respiratory depression in children who are ultra-rapid metabolisers and whose bodies concert codeine into morphine at a faster than normal rate.
The review only covers nationally authorised medicines and so the PRAC will pass its recommendations to the CMDh, the regulatory body that represents national competent authorities of EU Member States.