EFPIA says it is disappointed with the proposals in EU plan to revise guidance
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has called on the European Commission to propose comprehensive and detailed reforms to the European Union’s (EU) paediatric medicines regulation.
In comments to a Brussels plan to revise guidance on applications for paediatric investigation plans, EFPIA said it was disappointed with the proposals. Notably, it said they did not effectively address the 'high number of requests for modification' to such plans during medicine development.
This is because they are often submitted early, with research discoveries having to be incorporated in paperwork.
'The draft revised guideline included in this concept paper does not seem to have done much to address this issue,' said the EFPIA.
It recommended a 'stepwise approach' where companies submit a 'high level' plan upon completion of adult pharmacokinetic studies, adding more detail later 'once the company is in a better position to provide…more detailed plans'.
Pharma major Pfizer supported EFPIA, noting that the consultation paper did not propose substantial changes – 'the preferred eventual solution, as the paediatric legislation has significant potential for improvement'.
The company made detailed suggestions, such as simplifying the administrative and product information form, which 'is difficult to use, particularly for injectables'.