Testing of Pediatric Medicine has been an area under debate for some time. The EU Regulation on Paediatric Medicines1 came into force on 26 January 2007 and the procedures outlined will become law, 18 months following that date.


The main aims of the regulations are to:

(i) increase availability of medicines specifically adapted and licensed for use in the paediatric population,

(ii) make more information available to the patient/carer and prescriber about the use of medicines in children, including clinical trial data

(iii) promote high quality research into medicines for children.


The new regulations mean that for new products and certain changes to the marketing authorisation for products still covered by patent protection there will be a requirement for paediatric data based on a paediatric investigation plan (PIP).


Incentives are :
(i) a six-month extension of the supplementary protection certificate (SPC) even if the product is not finally authorised for paediatric use.


(ii) An additional year of data exclusivity for a new indication of an exisitng product.


(iii) A two year extension of orphan drug exclusivity if a PIP is fully complied with.


(iv) A Paediatric Use Marketing Authorisation (PUMA) of existing medicines will which will be associated with a ten-year period of data and market protection


MedPharm’s expertise in liquid and gel formulations can be applied to paediatric medicines for transdermal, buccal, oral and nasal drug delivery. However cutting edge design and a truly innovative approach to solving the problems of delivering accurate and precise dosages to children are paramount to the success of any therapy. As such MedPharm is also developing novel and exciting new technologies to provide accurate and speedy delivery of a drug in a mode that is easy to use for both medical professionals and parents and is well tolerated by children.  As such, MedPharm has Intellectual Property they have developed which can be applied to paediatric drug delivery to ensure a robust and effective solution.


[1 Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (Official Journal L378,27/12/2006 p1-19) ]