Paediatric Investigation Plans (PIP's)

With the introduction of Regulation (EC) 1901/2006 “Medicinal Products for Paediatric Use” which entered into force on 26 January 2007 pharmaceutical companies are required to submit a Paediatric Investigation Plan to the Paediatric Committee (PDCO) at the European Medicines Agency (EMEA) around the end of the first phase of testing a new drug in adults.  Any European Marketing Authorisation Application not accompanied by an approved Paediatric Investigation Plan will be automatically rejected.

EPMC has extensive experience in the development of Paediatric Investigation Plans (PIP’s).  Over the last three years we have successfully helped our clients to design PIP’s in indications such as Pain, Asthma, Antibiotics, Cardiovascular, Antiviral and Vaccines.  By working with EPMC you gain time on your future Regulatory Applications by relying on our expertise and flexibility.

In the completed PIP, EPMC helps to provide background on the targeted indication including the available treatments and information relating to its epidemiology, the positioning and formulation of your new medicine and all details relation to the proposed non-clinical and clinical testing protocols.



Development of Medicinal Products for Paediatric Use

Scientific Advice for Paediatric Development

Paediatric Investigation Plans [Preparation, submission and evaluation by the Paediatric Committee (PDCO) of the European Medicine Agency (EMEA) and subsequent approval by the EMEA

Clinical studies in children (facilitated through paediatrician networks)

Paediatric Use Marketing Authorisation (PUMA) Applications

Providing legal advice on issues related to incentives granted by Regulation (EC) n°1901/2006, including marketing protection and six-month extension of Supplementary Protection Certificates