Although medicinal products for use in adults undergo extensive pharmacological, stability and toxicological testing through clinical trials, this same approach has not always been applied to medicinal products to treat children.  As a result, many products are used “off-label” and unauthorised to treat children with subsequent associated risks of lack of efficacy and/or adverse reactions.

The Paediatric Regulation (EC) No 1901/2006 became effective in Europe on 26-Jan-2007.  This comprises several core elements in respect to collection of information on medicinal products, supported by a variety of rewards, incentives and penalties, the introduction of a paediatric committee and transparency measures.  The overall objective was to improve the health of the children of Europe by increasing the research, development and authorisation of medicinal products for use in children.  The regulation intended to achieve these objectives without subjecting children to unnecessary clinical trials and in full compliance with the EU CTD.

According to Article 50 (2) of the Paediatric Regulation, by 26 January 2013 the Commission had to present to the European Parliament and the Council a general report on experience acquired as a result of the application of this Regulation. The report has now been published and covers the period from January 2007 to December 2011 and shows that the implementation has already had a positive impact in keeping with the main objectives of the Paediatric Regulation, and that paediatric development is increasing.  By the end of 2011, 29 Paediatric Investigational Plans (PIPs) had been completed in compliance with the paediatric committee decisions, which led to new paediatric indications (24 medicines) and to new pharmaceutical forms appropriate for children (seven medicines). It was noted that data from five completed PIPs provided important information which did not support the use in children and this information was detailed in the Product Information for the benefit of health care professionals. Ten new medicinal products were centrally authorised and received a paediatric indication (out of 113 new active substances in total between 2008 and 2012), under the requirements of the Paediatric Regulation.  Unfortunately, there has been little progress in achieving the main objectives of the Paediatric Regulation for paediatric oncology which can be partly explained by the difference in clinical conditions between adults and children. It was stipulated that steps need to be taken to improve this in the future.

The report showed that new Information on the use of paediatric medicines had improved with the addition of new study data and new recommendations into the Summary of Product Characteristics.  Through implementation of PIPs and increased contribution to paediatric development, the availability of age-appropriate medicines is increasing.

The ADAMAS Corporate Brochure 2016


Brochure – Please download the ADAMAS brochure describing our QA services and contact details.

Regulatory Environment


The development of medicines is the most regulated industry in the world, and compliance at each stage of the research and development process, as well as after licensing, is critical to ensuring high quality and safe medicines reach patients in a timely manner.



ADAMAS’s consultants have expertise across the G’X’Ps in pre-clinical, clinical and post-licensing areas. They have worked across many different therapeutic areas and product types including oncology, vaccines, biologics, medical devices and gene therapy. As a company we have developed close partnerships with our clients to support them in their development programmes and post-licensing activities, and to guide them successfully through their worldwide regulatory inspections.


How to be a Clinical Auditor


‘So you want to be a Clinical Auditor?’, an article written by CEO Dr. Patricia Fitzgerald.

Benchmarking Data


Please download our benchmarking data sheet, to see how these data compare with your own performance. To discuss a more detailed report, or analysis of a data subset, please get in touch.

Is your QMS compliant?


Is your QMS compliant to the upcoming ICH E6 Addendum? Download our 5-point checklist

ICH (E6) R2 Addendum - Step 4


Please enter your details to complete the download.



Want to become one of the first businesses to access our exclusive data?
Get going and start reducing risk today. Pre register now.