EMA gives first paediatric use marketing authorisation
09.09.11
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has given its first approval for a paediatrics use marketing authorisation (PUMA) for epilepsy medicine Buccolam.
PUMA can be granted for medicines which are already authorised, but no longer patented, and which will be developed specifically for children. These medicines benefit from 10 years of market protection as a reward for the development in children.
EFPIA Director General, Richard Bergström said:
“It is good news that the first PUMA is now under way. Many people in industry will watch carefully what will happen in practice. Presumably, many of the paediatric uses that would be relevant for a PUMA are founded on established, but not documented, practice. If so, pharmacies may, through compounding already supply unapproved medicines.
Will these compounding practices stop with the arrival of a PUMA? This is not clear, which is one reason why I think companies have been hesitant. As an illustrative example, in the case of this first PUMA, the state-owned compounding company in Sweden (APL) already sells a competitor to Buccolam. Presumably, that product should now be taken off the market. And that is only one example. A company with a PUMA will have to work hard to remove unfair competition in all 27 markets.”
According to the EMA’s press release on PUMA:
“In the past, many medicines authorised in Europe were not studied adequately in children. This caused difficulties for prescribers and pharmacists treating children. A dedicated development of established medicines in children ensures that prescribers can base their treatment on adequate information on the efficacy and safety of a medicine and prescribe the correct dose and use the appropriate pharmaceutical form”
For further information on paediatrics use marketing authorisation:
- Visit the EMA website
- Read the following articles: Pharma Times and Inpharm.
