EMA Launches Pediatric Drug Pilot Project
The agency creates initiative to stimulate pediatric drug development.
The European Medicines Agency (EMA) has announced the launch of a one-year pilot project that offers free interactive meetings with drug developers to discuss the potential for a drug’s use in pediatric patients before submission of a pediatric investigation plan (PIP). Pharmaceutical companies in the European Union that develop new drugs must also develop the drug to treat pediatric patients, and EMA’s Paediatric Committee (PDCO) must approve these PIPs.
During PIP assessments, EMA has found issues with the integration of adult and pediatric drug-development programs submitted by pharmaceutical companies causing potential delays in getting those drugs to children who need them. EMA hopes this pilot project will help developers optimize their drug-development programs and, therefore, speed up pediatric access to the medicine.
Source: EMA
Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
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