SIOPE.EU - Revised off-patent PD medicines prior list

EMEA PRIORITY LIST FOR STUDIES INTO OFF-PATENT PAEDIATRIC MEDICINAL PRODUCTS

EMEA (The European Medicines Agency) has revised the paediatric priority drug list.

The aim of Regulation (EC) 1901/2006 of the European Parliament and the Council on Medicinal Products for Paediatric Use, as amended, is to increase availability of medicines authorised for children as well as to increase the information available on the use of medicinal products in the paediatric population. The Regulation includes provisions for funding of studies into off-patent medicinal products.

To access the list of off-patent products revised by the EMEA Paediatric Committee (PDCO) on 03/07/2009, please click here.
To view the joint comments by the ITCC and SIOPE to the EMEA Consultation, please click here.

Background

In July 2008, SIOPE and ITCC sent joint comments on the EMEA revised list.

According to Professor Gilles Vassal (ITCC), ' the list of compounds to be studies in infants through appropriate PK/PD/PG programme has been extended to better cover the needs in both solid tumours and leukemia'.

Moreover, ' among the three transversal programs, we think that pharmacology in infants is the most relevant one for a US-EU funded project. There is a strong rationale to joint forces considering the rarity of the population concerned. In addition, collaboration in between EU and US is ongoing for several diseases in infants that may facilitate the implementation of a pharmacology program'.

In November 2008, the two organisations also sent joint comments on the EMEA concept paper regarding the development of a quality guideline on pharmaceutical development of medicines for paediatric use.

Please click here to access the original comments submitted to EMEA in July 2008.
Please click here to view the comments submitted to EMEA in November 2008.
To access the list of off-patent products revised by the EMEA Paediatric Committee (PDCO) on 29/08/2008, please click here.