New regulation of children's medicines

Pharmaceutical Technology Europe

Volumn 19, Issue 3, 2007, Pages 19-20

  Martin, Andy ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

ORPHAN DRUG;

ARTICLE; CHILD HEALTH CARE; DRUG CONTROL; DRUG EFFICACY; DRUG FORMULATION; DRUG INDICATION; DRUG INDUSTRY; DRUG INFORMATION; DRUG LABELING; DRUG LEGISLATION; DRUG MANUFACTURE; DRUG MARKETING; DRUG RESEARCH; DRUG SAFETY; EUROPEAN UNION; HEALTH PROGRAM; MEDICAL ETHICS; PATENT; PHARMACEUTICAL CARE; PRESCRIPTION; REIMBURSEMENT;

EID: 33947432894     PISSN: 01646826     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (6)

1. Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (Official Journal L378,27/12/ 2006 p 1-19).
2. http://ec.europa.eu/enterprise/pharmaceuticals/paediatrics/docs/ overview∠d∃planation_of_the∥oposal_1.pdf
3. Note for guidance on clinical investigation of medicinal products in the paediatric population (CPMP/ICH/2711/99). www.emea.eu.int/pdfs/human/ich/ 271199en.pdf
4. Summary of regulation on medicines for paediatric use.
5. www.fda.gov/cder/pediatric
6. http://ec.europa.eu/enterprise/pharmaceuticals/paediatrics/docs/ paeds≙hics_consultation20060929.pdf