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Paediatric regulation

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EudraCT & EU CTR Frequently asked questions

EudraCT & EU CTR Frequently asked questions

eudract.ema.europa.eu

Which paediatric studies fall under Article 45 of Regulation (EC) No 1901/2006 and . EudraCT & EU CTR Frequently asked questions . EudraCT & EU CTR Frequently asked questions CTR)? this. ]., .

  Regulations, Paediatric

The European regulatory system for medicines

The European regulatory system for medicines

www.ema.europa.eu

Paediatric Committee (PDCO) National Competent Authorities The national competent authorities (NCAs), responsible for the regulation of human and veterinary medicines in the EU, coordinate their work in a forum called Heads of Medicines Agencies (HMA). The heads of the NCAs work closely with EMA and the European Commission to maximise

  Regulations, Paediatric

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