EU paediatric regulation – Does it affect you?
Are you ready for the challenges and opportunities that the new paediatric legislation will bring?

The new paediatric legislation ((EC) No 1901/2006; amended in No 1902/2006) aims to improve the safety and efficacy of medicines for children. A new expert body, the Paediatric Committee (PDCO), now meet 10 times a year to oversee the regulation and review Paediatric Investigation Plans (PIPs).

New and patent-protected products

All new medicine applications made after 26th July 2008 must include results of a PIP, which has been approved by the PDCO. The PIP sets out the studies which must be conducted to assess the use in children. The PDCO may grant (i) a waiver if they assess that use in children is not relevant or (ii) a deferral for some or all of the sub-groups in the paediatric population if it is appropriate to gain experience in adults first. The completion of an agreed PIP will result in an additional 6 months of patent protection.

Line extension applications made after 26th January 2009 for new administration routes/pharmaceutical forms/indications must also have a compliant PIP.

Products not covered by a patent (generic and well established use products)

From 26th July 2007 companies have been able to apply for a new kind of marketing authorisation called the Paediatric Use Marketing Authorisation (PUMA). These are not mandatory, but successful PUMA applications will be granted with a 10 year period of data exclusivity and protection.

Orphan medicinal products

Information arising from a completed PIP will be rewarded with 2 years of market exclusivity beyond the 10 years which they are granted under existing EU legislation.

CambReg can:

• Advise on how to comply with the new legislation
• Help prepare your PIP
• Prepare PUMA submissions
• Organise for your clinical trial to be done with our Global CRO partner

A PIP needs to be considered as early as Phase 1 in your product development.

Our in-house expertise can help you reach your goal in the quickest, most cost effective manner. We can help you plan your route, avoid pitfalls and work within your budget, leaving you free to concentrate on developing your product.

From dossier completion to advice and training, CambReg’s highly skilled team provide added value to your regulatory projects.

For a free discussion of how the paediatric regulation may affect your company, to request a free, no obligation visit (30 minute presentation on the challenges and incentives brought by the regulation – within the UK only) or to request further information on our services please call 01480 465755 or go to our contact page.