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Paediatric regulation
Found 2 free book(s)EudraCT & EU CTR Frequently asked questions
eudract.ema.europa.euWhich 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. ]., .
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