Since December 2006, the Regulation (EC) No 1901/2006 on Medicinal Products for Paediatric Use is in operation. And this regulation is mandatory for all pharmaceutical companies developing new products. The Paediatric Regulation and guidelines in the EU but also the U.S. require pharmaceutical companies to review their research and development strategies and their allocation of resources. An active dialogue between sponsors, pharmaceutical industry, regulators and CROs is essential for a successful implementation of the Guideline.
The European Medicines Agency EMA is now developing a European paediatric network of existing national and European networks, investigators and centers with specific expertise in the performance of paediatric studies. The name of the network will be ENPREMA (European Network of Paediatric Research at the European Medicines Agency).
As a first step, a working group with members of identified networks elaborated six criteria for self-assessment which will have to be fulfilled to become a member of the European paediatric network.
The criteria should be reported for the highest level that is currently attained and focus for example only on the actual status of the network, and not on single individual investigators or sites. The document should be filled in by the reporting party (once only per network), sent to the European Medicines Agency and should be made public by the reporting party, for example, on their web site. The evidence for the self-assessment document should be based on the network's activities in the last 5 years and should have a reference (e.g. publication, annual or periodic report or internal network document).
The six criteria are:
The document can be found here. The end of consultation (deadline for comments) is 05 March 2010.
Because the development of paediatric formulations requires specific knowledge and skills combined with the flexibility to introduce new and sophisticated dosage forms to both development and production, the European Compliance Academy (ECA) has set up a conference on Formulation Development and Manufacturing of Paediatric Drugs (19 - 20 May 2010 in Vienna, Austria). At this Conference, all relevant aspects of paediatric formulation development and manufacturing will be addressed. Questions like suitable dosage forms, acceptable daily intake, taste masking, dosing accuracy, manufacturability and compliance issues will be discussed in various case studies. Besides experts from industry, also speakers from EMEA PDCO and the FDA Office of Pediatric Therapeutics will talk about their experiences and will share their point of view.
On behalf of the European Compliance Academy (ECA)