Rewards and incentives for paediatric medicines in European Union

Published by EMA

Paediatric IncentiveMarket ExclusivityReward

This guide provides some rewards and incentives to encourage investment in research and development of medicines for children in European Union. E.g Peadiatric medicinces once they receive a marketing authorisation, they benifit additional 6 months of market exclusivity regardless patent expiration. Medicines once approved for children that are not protected by a patent or supplementary protection certificate are eligible for a paediatric-use marketing authorisation (PUMA). If a PUMA is granted, the product will benefit from 10 years of market protection.

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Rewards and incentives for paediatric medicines in USA

Published by FDA

Paediatric IncentiveMarket ExclusivityReward

This guide provides an incentive of FDA. Drugs for peadiatric once they receive a marketing authorisation in USA, they benifit additional 6 months of market exclusivity regardless patent expiration. This incentive is to encourage the development of drugs for children to prevent from other competitors selling similar drugs for similar diseases.

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