Drug regulation: History, present and future

Drug Benefits and Risks: International Textbook of Clinical Pharmacology

Volumn , Issue , 2008, Pages 65-77

  Rägo, Lembit ^a   Santoso, Budiono ^a  

^a WORLD HEALTH ORGANIZATION   (Switzerland)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 84880184814     PISSN: None     EISSN: None     Source Type: Book    
DOI: None     Document Type: Chapter

References (39)

1. Bankowski, Z. editor. International guidelines for ethical review of epidemiological studies. Geneva: Counsil for International Organizations of Medical Sciences; 1991.
2. Ceci A, FelisiM, CatapanoM, Baiardi P, Cipollina L, Ravera S et al. Medicines for children licensed by the European Agency for the Evaluation ofMedicinal Products. Eur J Clin Pharmaco 2002;58:495-500.
3. CIOMS. International reporting of adverse drug reactions (Report of CIOMSWorking Group I). Geneva: Counsil for International Organizations of Medical Sciences; 1990.
4. CIOMS. International reporting of periodic drug-safety update summaries (Report of CIOMS Working Group II). Geneva: Counsil for International Organizations of Medical Sciences; 1993.
5. CIOMS. International ethical guidelines for biomedical research involving human subjects. Geneva: Counsil for International Organizations of Medical Sciences; 2002 [cited 2008 Jan 13]. Available from: URL: http://www.cioms.ch/frame_guidelines_nov_2002.htm.
6. CIOMS. Pharmacogenetics: towards improving treatment with medicines (Report of the CIOMS Working Group). Geneva: Counsil for International Organizations of Medical Sciences; 2005.
7. CIOMS. The development safety update report (DSUR): harmonizing the format and content for periodic safety reporting during clinical trials (Report of CIOMS Working Group VII). Geneva: Counsil for International Organizations of Medical Sciences; 2006.
8. Declaration of Helsinki. World Medical Association; 2004 [cited 2008 Feb 25]. Available from: URL:http:// www.wma.net/e/policy/b3.htm.
9. Fargher EA, Tricker K, Newman B, Elliott R, Roberts SA, Shaffer JL, Payne K. Current use of pharmacogenetic testing: a national survey of thiopurine methyltransferase (TPMT) testing prior to azathioprine prescription. J Clin Pharm Ther 2007;32:187-95.
10. Gaspar R. Regulatory issues surrounding nanomedicines: setting the scene for the next generation of nanopharmaceuticals. Nanomed 2007;2(2):143-7.
11. GazarianM, Kelly M, McPhee JR, Graudins LV, Ward RL, Campbell TJ. Off-label use of medicines: consensus recommendations for evaluating appropriateness. Med J Aust 2006;185:544-8.
12. Grabinski JL. Pharmacogenomics of anticancer agents: implications for clinical pharmacy practice. J Pharm Pract 2007;20(3):246-51.
13. Griffin JP, Shah RR. History of drug regulation in the UK. In: O'Grady J, Griffin JP, editors. The regulation of medical products. London: Blackwell BMJ Books; 2003. p. 3-12.
14. Hari P, Jain Y, Kabra SK. Fatal encephalopathy and renal failure caused by diethylene glycaol poisoning. J Trop Pediatr 2006;52(6):442-4.
15. Irs A, De Hoog TJ, Rägo L. Development of marketing authorization procedures for pharmaceuticals. In: Freemantle N, Hill S, editors. Evaluating pharmaceuticals.
16. for health policy and reimbursement. London: Blackwell BMJ Books; 2004. p. 3-24.
17. Maynard A, Aitken RJ, Butz T, Colvin V, Donaldson K, Oberdörster G et al. Safe handling of nanotechnology. Nature 2006; 444(7117):267-9.
18. O'Brien KL, Selanikio JD, Hecdivert C, Placide MF, Louis M, Barr DB et al. Epidemic of pediatric deaths from acute renal failure caused by diethylene glycol poisoning. Acute Renal Failure Investigation Team. JAMA 1998;279(15):1175-80.
19. Permanand G, Mossialos E, McKee M. Regulating medicines in Europe: the European Medicines Agency, marketing authorisation, transparency and pharmacovigilance. Clin Med 2006;6(1):87-90.
20. Ratanwijitrasin S, Wondemagegnehu E. Effective drug regulation. A multicountry study. Geneva: World Health Organization; 2002.
21. Rägo L. ICH and global cooperation in the new millennium: WHO perspective. In: Cone M, editor. Proceedings of the fifth international conference on harmonisation, San Diego, 2000. London: PJB Publications Ltd; 2001. p. 299-304.
22. Rägo L. Global disequilibrium of quality. In: Prince R, editor. Pharmaceutical quality. River Grove (IL): Davies Health Care International Publishing; 2004. p. 3-21.
23. The important world of prequalification [editorial]. Lancet 2004;346:1830.
24. The International Pharmacopoeia, 4th ed. Vol 1: General notices; monographs for pharmaceutical substances (A-O). Vol 2: Monographs for pharmaceutical substances (P-Z); monographs for dosage forms and radiopharmaceutical preparations; methods for analysis; reagents. Geneva: World Health Organization; 2006.
25. Trouiller P, Olliaro P, Torreele E, Orbiniski J, Laing R, Ford N. Drug development for neglected diseases: a deficient market and a public health policy failure. Lancet 2002;359:2188-94.
26. WHO. Ethical criteria for medicinal drug promotion. Geneva: World Health Organization; 1988.
27. WHO. Guiding principles for small national drug regulatory authorities. In: WHO Expert Committee on Specifications of Pharmaceutical Products. Geneva: WHO; 1990. p.64-79. (Technical report series; no 790).
28. WHO. A legislative scheme for regulating medicinal products for adaptation by small national drug regulatory authorities with limited manpower and other resources. Geneva: World Health Organization; 1993. (WHO/PHARM/93.244; annex 3).
29. WHO. Guidelines for good clinical practice (GCP) for trials on pharmaceutical products. Geneva: World Health Organization; 1995 [cited 2008 Jan 13]. (WHO Technical report series; no. 850, annex 3). Available from: URL: http://www.who.int/ medicines/library/par/ggcp/ GGCP.shtml.
30. WHO. Marketing authorization of pharmaceutical products with special reference to multisource (generic) products. A manual for a drug regulatory authority. Geneva: World Health Organization; 1999. (WHO/DMP/RGS/98.5).
31. WHO. Guidelines for the regulatory assessment of medicinal products for use in self-medication. Geneva:World Health Organization; 2000. (WHO/EDM/QSM/00.1).
32. WHO. Operational guidelines for ethics committees that review biomedical research. Geneva: WHO; 2000 [cited 2008 Jan 13]. Available from: URL:http://www. who.int/tdr/publications/publications/ethics.htm.
33. WHO. Surveying and evaluating ethical review practices. A complementary guideline to the operational guidelines for ethics committees that review biomedical research. Geneva: World Health Organization; 2002 [cited 2008 Jan 13]. Available from: URL:http://www. who.int/tdr/publications/publications/ethics.htm.
34. WHO. Introduction to drug utilization research, Geneva: World Health Organization; 2003 [cited 2008 Feb 25]. Available from: URL:www.who.int/medicines/areas/ quality_safety/safety_efficacy/utilization/en/.
35. WHO. Effective medicines regulation: ensuring safety, efficacy and quality. Geneva: World Health Organization; 2003 [cited 2008 Jan 7]. (WHO policy perspectives on medicines; no 7). Available from: URL: http:// whqlibdoc.who.int/hq/2003/WHO_EDM_2003.2.pdf.
36. WHO. Handbook for good clinical research practice (GCP): guidance for implementation. Geneva: World Health Organization; 2005 [cited 2008 Jan 13]. Available from: URL:www.who.int/prequal/ info_general/documents/GCP/gcp1.pdf.
37. WHO. Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Fortieth report. Geneva: WHO; 2006 [cited 2008 Jan 19]. p. 347-390. (WHO Technical report series; no 937, annex 7). Available from: URL:http://www.who.int/ medicines/publications/pharmprep/en/index.html.
38. WHO. International nonproprietary names (INN) for pharmaceutical substances [CD-ROM]. Geneva: World Health Organization; 2007. Available from: URL:http://bookorders.who.int/bookorders/anglais/ qsearch1.jsp?sesslan=1.
39. WHO. Quality assurance of pharmaceuticals. A compendium of guidelines and related materials, vol 2, 2nd update ed. Good manufacturing practices and inspection. Geneva: World Health Organization; 2007.