News briefs...
The European Parliament and the Council of Ministers have struck a deal over an EU regulation that will allow European manufacturers to produce copies of patented medicines for sale to developing countries undergoing health crises. This means the law will be approved without receiving second reading from both institutions.
A reformed fee structure for the European Medicines Agency (EMEA) has been agreed by the Council of Ministers. This includes reducing fees for authorising generic drugs and making minor changes to market approvals. The deadline for fee payment will be extended to 45 days. EMEA has issued guidance on the changeover to its new charging system.
The confidentiality agreement signed in 2003 between the Commission, EMEA and the FDA will be extended for another five years to 2010, following a 'positive experience' from the initial deal, which allows the parties to exchange information during their mutual regulatory duties.
EMEA has issued guidance on seeking authorisations for biological medicinal products similar to those already having market approvals. It has also issued a guideline on the need for post-authorisation data on the exposure of pregnant patients to medicines.