Brussels asks whether EU paediatric medicine rules should be more flexible

The European Commission is consulting the pharma sector on planned changes to the European Union’s (EU) paediatric medicine development guidelines.

Brussels wants to know whether the existing regulation – (EC) 1901/2006 – is too much of a legislative straitjacket for regulators and the companies they work with. And it wonders whether regulators should be given more flexibility in deciding how to assess a medicine: 'Is it appropriate to list key elements in this guideline or should key elements only be specified in the individual decision of the agency agreeing a specific paediatric investigation plan?' asked a Commission consultation document.

Another reform for consideration would change how regulators agree amendments to previously approved inquiries into how these medicines might work. And a different proposal would update how regulators ensure pharma companies have complied with paediatric medicine rules. A fourth proposal would change the criteria helping regulators decide what paediatric medicine studies are 'significant'.

The Commission wants comments by 18 December.

The proposed changes follow advice from the European Medicines Agency (EMA) and its paediatric committee. They considered that the guideline 'could benefit from some improvement and adaptation to current implementation, but that its general structure and content did not require substantial changes', the Commission noted. That said, EMA proposed a new wording that deleted unnecessary or repetitive details, and simplified its language.

Moreover, EMA wants pharma companies to include application summaries with applications’ scientific documents. And it stressed the possibility of having multiple assessments investigating the same paediatric medicine. The reforms would change guidance in place since 2008.