EMA Looks to Allow More Regulatory Flexibility for Pediatric Plan Submissions

The European Medicines Agency (EMA) has announced the publication of a new policy on making changes to pediatric investigation plan (PIP) decisions.

PIPs are mandated by Regulation EC 1901/2006, which states that any medicinal product intended for pediatric use must include a plan to conduct testing sufficient to obtain necessary data to support a marketing authorization application (MAA). A PIP is also necessary when applying for new indications, new routes of administration or new product forms.

EMA notes in its 27 July Policy on changes in scope of paediatric investigation plan decisions that companies often wish to change their original plans or adjust the timing of a particular submission based on emerging information.

In a statement, the agency said the new policy will allow PIPs to be extended or merged if a company wishes to apply for one or more new marketing indications for a product. Conversely, a company may also split or subtract from a PIP if it later decides it wishes to apply for fewer indications.

"The consequence is that the content of EMA Decisions on Paediatric Investigations Plans (PIPs), often made several years previously, may not correspond to the content of the eventual marketing authorization (MA) application or variation/line extension," writes EMA. The ability to either split or join PIP decisions can allow for products to achieve market access faster, EMA observed, particularly because the PIP is attached to rewards and other incentives to spur investment in the area.

EMA's policy guide provides the procedures to either join or split an application, as well as specific examples, and goes into effect immediately.

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