Three years of the EU Paediatric Regulation - what happened?

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!

What were the consequences for Pharmaceutical Development?

The pharmaceutical industry had and still has to integrate all the paediatric aspects in the complete development process and has to assess the paediatric use for both products in early and late development and already authorised products. Data must be generated for Marketing Authorisation of all new products since July 26, 2008 and new indications, pharmaceutical dosage forms and routes of admission since January 26 2009.

As a consequence, a sound paediatric development strategy was needed, where various challenges are considered and addressed. The mandatory activities implemented by the Regulation have been leading to additional efforts and costs with increased pressure in a competitive environment. These efforts range from small additional developments activities to full development programs, which can be very time consuming. And depending from the envisaged marketing strategy, global paediatric legislation needs to be considered and followed. For the U.S. FDA for example, the paediatric program (called BPCA and PREA) is usually first discussed at the end of Phase 2 before initiation of Phase 3. However an earlier interaction with the FDA may be advisable to discuss for example epidemiology, therapeutic needs and the clinical development concept. It might also be recommendable to submit the same PIP to FDA and EMEA PDCO. But because of other differences between the European and the U.S. concept, it may be necessary to implement separate clinical development programs.

So what paediatric formulations should be developed? Many children have problems swallowing tablets. But this is also true for certain liquid formulations. Suppositories might be an option in countries like Germany or some Mediterranean states but will face ethical resistance in the U.K. or the U.S. As a consequence, also other possibilities for paediatric formulations should be evaluated.

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.

Another Part of the conference will address the topic Quality by Design and Efficiency in Pharmaceutical Development (this part will start on 18 May 2010)

Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)

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