Role of the EMEA in accompanying product development

Pharmaceuticals Policy and Law

Volumn 1, Issue , 1999, Pages 9-23

  Sauer, Fernand ^a   Moulon, Isabelle ^a  

^a EUROPEAN MEDICINES AGENCY   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 85013613792     PISSN: 13892827     EISSN: 2210495X     Source Type: Journal    
DOI: None     Document Type: Article

References (12)

1. Council Regulation (EEC) No 2309/93 of 22 July 1993 (OJ L214, 24.8.1993)
2. Volume I to VII "The rules governing medicinal products in the European Union", Office for Official Publications of the European Communities (In particular Vol. III - Guidelines on the quality, safety and efficacy of medicinal products for human use).
3. European Agency for the Evaluation of Medicinal Products - First General Report, EMEA, 1995, ISBN 92-827-7491-0, Office for Official Publications of the European Communities.
4. European Agency for the Evaluation of Medicinal Products - Second General Report, EMEA, 1996, ISBN 92-9155-003-5, Office for Official Publications of the European Communities.
5. European Agency for the Evaluation of Medicinal Products - Third General Report, EMEA, 1997.
6. Workprogramme for the European Agency for the Evaluation of Medicinal Products 1998/1999.
7. Accelerated Evaluation of Products indicated for serious Diseases (Life threatening or heavy disabling diseases), EMEA, 1996, CPMP/459/96.
8. Scientific Advice to be given by the CPMP for Innovative Medicinal Products, EMEA, 1996, EMEA/SOP/002/95.
9. Scientific Advice to be given by the CVMP for innovative veterinary Medicinal Products, CVMP/SOP/098/96 Final.
10. Points to consider in the assessment of anti-HIV Medicinal Products (CPMP/602/95/Revision 1), 19 November 1997.
11. International Conference on Harmonisation (ICH 4, Brussels, 16 July 1997), Summary of Dr. Martin Bangemann’s speech - European Commission, Directorate General III, Industry Information and Communication Office.
12. Miller L, Buckley J and Crawley R, The interactive IND/NDA, Drug Information Journal 30 (1996), 593-599.