Europe opens door to partly tested medicines
The European Commission has created a new "conditional marketing authorisation" for partly tested medicines treating life-threatening diseases, where the risk of not using them outweighs the danger posed by potential side-effects.
The European Commission has created a new "conditional marketing authorisation" for partly tested medicines treating life-threatening diseases, where the risk of not using them outweighs the danger posed by potential side-effects.
Such approvals would last one year and bind manufacturers to completing studies to confirm a medicine's safety and effectiveness.
Announcing the reform, European Union Industry Commissioner Guenter Verheugen said: "Our initiative can make a real difference for patients suffering from life threatening diseases for which no treatment exists." Such authorisations could also be granted for "seriously debilitating diseases..medicines for use in emergency situations as well as medicines for rare diseases (orphan drugs)".
The Commissioner noted that under current rules it often takes 10 years for a new medicine to reach the market. Conditional authorisations would be made on recommendation of the European Medicines Agency's (EMEA) committee for medicinal products for human use.