EMEA holds tenth birthday conference
The European Medicines Agency, EMEA, has celebrated its 10th birthday. Set up to run alongside the national authorities in member states, initially products were obliged to use the centralised procedure only for biologic medicines, but now the majority of medicines are submitted to EMEA for approval.
The organisation held a celebratory conference near the agency's headquarters in London's Docklands, with politicians and representatives of industry and other regulators from around the world present.
Luxembourg's minister of health, Mars Di Bartolomeo, claimed that the creation of the agency from scratch was a 'remarkable' performance. 'One remarkable feature is that [it is] very rapidly able to give scientific opinion,' he said. He added that new challenges would include the new paradigm, Process Analytical Technology, which 'might change the way [producers manufacture] to ensure quality of medicinal products in the future'.
'Europe needs a strong and competitive pharmaceutical industry to deliver innovative medicines for the benefit of public health,' claimed the new Enterprise and Industry commissioner Guenter Verheugen, in a speech given by his department's director general Horst Reichenbach.
He went on to say that innovations in medical treatment will provide one of the biggest challenges for the future. 'The industry needs a clear regulatory framework for new technologies [such as gene therapy, cell therapies and tissue engineering]. If the regulatory framework is unclear, then this increases the uncertainty and risks for industry, and reduces innovation. The commission is committed to ensuring that a clear regulatory framework for these advanced therapies is put in place as quickly as possible.'
A note of dissent came from Daniel Vassella, chief executive of Novartis, who, referring to recent product withdrawals and resultant health scares, said: 'we cannot succumb to the temptation to go for immense [clinical] studies. The result would be to slow down pharmaceutical advances.'