Regulation (EC) No 1901/2006 on medicinal products for paediatric use & clinical research in vulnerable populations

Child and Adolescent Psychiatry and Mental Health

Volumn 2, Issue , 2008, Pages

  Lehmann, Birka ^a  

^a Bundesinstitut für Arzneimittel und Medizinprodukte ^*  (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG;

CHILD HEALTH CARE; CLINICAL RESEARCH; DRUG INDUSTRY; DRUG LEGISLATION; DRUG MANUFACTURE; HEALTH CARE PERSONNEL; HUMAN; MEDICAL PRACTICE; MEDICAL SOCIETY; PEDIATRICS; PHARMACEUTICAL CARE; PRACTICE GUIDELINE; PRIORITY JOURNAL; REVIEW; REWARD; VULNERABLE POPULATION;

EID: 60649088087     PISSN: None     EISSN: 17532000     Source Type: Journal    
DOI: 10.1186/1753-2000-2-37     Document Type: Review

References (9)

1. Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use http://europa.eu/eur-lex/pri/ en/oj/dat/2001/l_121/l_12120010501en00340044.pdf
2. ICH E11 Clinical investigation of medicinal products in the paediatric population (CPMP/ICH/2711/99) http://www.emea.europa.eu/pdfs/human/ich/ 271199en.pdf
3. Publication European Commission: Discussions in the Council are progressing well and the proposed Regulation on medicinal products for paediatric use will be discussed at the Health Council of 9 December 2005 http://ec.europa.eu/enterprise/pharmaceuticals/paediatrics/ medchild_key_en.htm
4. Heads of Medicines Agencies http://www.hma.eu
5. European Medicines Agency: Priority list of off-patent medicines http://www.emea.europa.eu/htms/human/paediatrics/prioritylist.htm
6. European Medicines Agency: EU paediatric network http://www.emea.europa.eu/htms/human/paediatrics/network.htm
7. European Medicines Agency: Scientific advice http://www.emea.europa.eu/ htms/human/paediatrics/sci_advice.htm
8. European Medicines Agency: Paediatric Needs http://www.emea.europa.eu/ htms/human/paediatrics/inventory.htm
9. European Medicines Agency: Scientific guidance http://www.emea.europa.eu/ htms/human/paediatrics/sci_gui.htm