European Paediatric Medicines Database (EPMD)
EPMD is a database containing information on paediatric drugs authorised by the European Medicines Agency (EMA) under the centralised procedure. It is aimed to create a harmonised, integrated and reliable European source of information by collecting data from different sources (national authorities, regulatory bodies, pharmaceutical companies). It is an useful instrument to provide all the stakeholders with appropriate information concerning the rational use of paediatric medicines and to identify unmet medical needs in paediatrics: healthcare professionals, institutional bodies, companies, patients’ associations and families can freely access to the database.
A report about information on EMA authorised drugs with a paediatric indication is periodically produced and disseminated throughout the Network. The last report is available here in PDF format:
Periodic report on drugs approved for children under the EU Centralised Procedure
Annex_List of the paediatric MAs/variations in 2014
TEDDY Ethics Committees Surveys
Results from two TEDDY surveys investigating the national and local level of the ethic procedures applied in Europe with reference to pediatric trials approval. The surveys have been conducted following an inventory of:
- the Competent National Authorities and
- the Ethics Committees operating in Europe with all the website addresses and contact details.
TEDDY Inventory of procedures for obtaining Paediatric Clinical Trials approvals
A database containing information on the relevant local requirements and procedures to carry out the Clinical Trial Application in several European and non-European countries.
The list includes the following countries and is regularly updated (last update December 2014):
- ALBANIA
- CYPRUS
- CZECH REPUBLIC
- EGYPT
- ESTONIA
- FRANCE
- GERMANY
- GREECE
- ITALY
- SWEDEN
- THE NETHERLANDS
- TUNISIA
- UNITED KINGDOM
Sources: Council of Europe, EudraLex, EFGCP, official national law databases.