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Regulatory News | 16 June 2015 | By Michael Mezher
The European Medicines Agency (EMA) is piloting a new initiative to offer early meetings with companies to foster discussions about their pediatric development strategies for new medicines.
Companies are often reluctant to conduct clinical studies in children due to ethical concerns and fear of adverse events during trials. However, conducting clinical research on children is critical to determining whether drugs are safe and effective in pediatric populations.
To ensure adequate research is conducted in pediatric populations, companies developing medicines in the EU are required to complete a paediatric investigation plan (PIP).
The requirements for a PIP are found in Regulation (EC) No 1901/2006 and Regulation (EC) No 1902/2006, known collectively as the Paediatric Regulation. However, while companies are generally required to conduct studies in pediatric populations, waivers can be granted for specific products and product classes:
Additionally, deferrals can be granted if, "it is appropriate to conduct studies in adults prior to initiating studies in the paediatric population or when studies in the paediatic population will take longer to conduct than studies in adults."
In the years since the Paediatric Regulations went into effect, EMA says it has "identified a number of issues which often delay the paediatric development" of new products. In turn, these delays either result in slower access to medicines for children, or authorized medicines that lack safety and dosage information for pediatric populations.
EMA is looking to address these delays by offering companies "free-of-charge early paediatric interaction meetings." Through these meetings, EMA hopes to iron out potential issues before a company submits a PIP.
EMA says it will pilot the initiative until June 2016 and will use the experience gained in the pilot to either continue or modify the initiative. The agency will be limited in how many early pediatric meetings it can facilitate through the pilot, so "medicines for rare diseases or high paediatric need" will be prioritized."
Tags: PIP, Pediatric Investigation Plan, Paediatric Investigation Plan