Regulation of vaccines in developing countries

Vaccines: Sixth Edition

Volumn , Issue , 2012, Pages 1454-1463

  Belgharbi, Lahouari ^a   Dellepiane, Nora ^a   Wood, David J ^a  

^a WORLD HEALTH ORGANIZATION   (Switzerland)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 84902041170     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1016/B978-1-4557-0090-5.00075-6     Document Type: Chapter

References (32)

1. WHO Expert Committee on Biological Standardization Forty-second report. Guidelines for national authorities on quality assurance for biological products. Tech Rep Ser 822 1992, Annex 2.
2. World Health Organization. WHO prequalified vaccines, [accessed 23.10.11]. http://www.who.int/immunization_standards/vaccine_quality/PQ_vaccine_list_en/en/index.html.
3. World Health Organization. Procedure for assessing the acceptability, in principle, of vaccines for purchase by United Nations agencies, [accessed 23.10.11]. http://www.who.int/immunization_standards/vaccine_quality/who_bs_2155_vaccines_prequalification_revised_procedure_ecbs_endorsed.pdf.
4. World Health Organization. Assessing the programmatic suitability of vaccine candidates for WHO prequalification, [accessed 23.10.11]. http://www.who.int/immunization_standards/vaccine_quality/ps_pq/en/index.html.
5. World Health Organization. Developing Countries Vaccines Regulators Network Establishment, [accessed 23.10.11]. http://www.who.int/immunization_standards/vaccine_regulation/dcvrn/en/index.html.
6. World Health Organization. African Vaccine Regulatory Forum, [accessed 23.10.11]. http://www.who.int/immunization_standards/vaccine_regulation/africa_network/en/index.html.
7. World Health Organization. Procedure for expedited review of imported prequalified vaccines for use in national immunization programmes. WHO/IVB/07.08, [accessed 23.10.11]. http://whqlibdoc.who.int/hq/2007/WHO_IVB_07.08_eng.pdf.
8. World Health Organization. Developing a global strategy for enhancing vaccine safety: meeting of the Global Advisory Committee on Vaccine Safety, June 2011. Wkly Epidemiol Rec 2011, 86:323-324. www.who.int/wer/2011/wer8630.pdf; [accessed 23.10.11].
9. World Health Organization. Committee Reports. Global Advisory Committee on Vaccine Safety, [accessed 23.10.11]. http://who.int/vaccine_safety/reports/en.
10. European Medicines Agency. Guideline on procedural aspects regarding a CHMP scientific opinion in the context of cooperation with the World Health Organization (WHO) for the evaluation of medicinal products intended exclusively for markets outside the community. Adopted 17/11/2005, [accessed 15.02.11]. http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000157.jsp&murl=menus/regulations/regulations.jsp&mid=WC0b01ac05800240d1#.
11. World Health Organization Meeting of the Strategic Advisory Group of Experts on Immunization, April 2010: conclusions and recommendations. Wkly Epidemiol Rec 2010, 85:203-204.
12. WHO Expert Committee on Biological Standardization. Forty-second report. Guidelines for national authorities on quality assurance for biological products. Tech Rep Ser 822 1992, Annex 2.
13. WHO Expert Committee on Biological Standardization Forty-fifth report. Regulation and licensing of biological products in countries with newly developing regulatory authorities. Tech Rep Ser 858 1995, Annex 1.
14. World Health Organization Vaccine Supply and Quality. National Control Authority, Guidelines for Assessment of Vaccine Quality in Non-producing Countries 1995, WHO/VSQ/95.1.
15. World Health Organization. Vaccine Supply and Quality Unit. GPV Policy Statement. Statement on vaccine quality 1997, WHO/VSQ/GEN/96.02.Rev.1.
16. World Health Organization Vaccines and Biologicals. Regulation of Vaccines: Building on Existing Drug Regulatory Authorities 1999, WHO/V&B/99.10.
17. World Health Organization. WHO prequalified vaccines, [accessed 23.10.11]. http://www.who.int/immunization_standards/vaccine_quality/PQ_vaccine_list_en/en/index.html.
18. World Health Organization. Procedure for assessing the acceptability, in principle, of vaccines for purchase by United Nations agencies, [accessed 23.10.11]. http://www.who.int/immunization_standards/vaccine_quality/who_bs_2155_vaccines_prequalification_revised_procedure_ecbs_endorsed.pdf.
19. WHO-UNICEF_UNFPA. Joint statement on the use of auto-disable syringes in immunization services, [accessed 23.10.11]. http://www.who.int/vaccines-documents/DocsPDF99/www9948.pdf.
20. World Health Organization. Assessing the programmatic suitability of vaccine candidates for WHO prequalification, [accessed 23.10.11]. http://www.who.int/immunization_standards/vaccine_quality/ps_pq/en/index.html.
21. Thompson F. End of a century-long scourge?. Bull World Health Organ 2011, 89:550-551. 10.2471/BLT.11.020811.
22. Australian Government Department of Health and Ageing Therapeutic Goods Administration. Australian public assessment report for Japanese encephalitis chimeric virus, [accessed 23.10.11]. http://www.tga.gov.au/pdf/auspar/auspar-imojev.pdf.
23. World Health Organization. Developing Countries Vaccines Regulators Network Establishment, [accessed 23.10.11]. http://www.who.int/immunization_standards/vaccine_regulation/dcvrn/en/index.html.
24. World Health Organization. African Vaccine Regulatory Forum, [accessed 23.10.11]. http://www.who.int/immunization_standards/vaccine_regulation/africa_network/en/index.html.
25. World Health Organization. Global learning opportunities for vaccine quality, [accessed 23.10.11]. http://www.who.int/immunization_standards/vaccine_quality/gtn_index/en/index.html.
26. Kirkpatrick D.L., Kirkpatrick J.D. Evaluating training programs 2009, Berrett-Koehler, San Francisco, CA.
27. World Health Organization. Procedure for expedited review of imported prequalified vaccines for use in national immunization programmes. WHO/IVB/07.08, [accessed 23.10.11]. http://whqlibdoc.who.int/hq/2007/WHO_IVB_07.08_eng.pdf.
28. World Health Organization. Data collection tools 2007: functions, indicators and sub-indicators, [accessed 28.11.11]. http://www.who.int/immunization_standards/vaccine_quality/nra_indicators_dec2007_english.pdf.
29. World Health Organization Developing a global strategy for enhancing vaccine safety: meeting of the Global Advisory Committee on Vaccine Safety, June 2011. Wkly Epidemiol Rec 2011, 86:323-324. www.who.int/wer/2011/wer8630.pdf; [accessed 23.10.11].
30. World Health Organization. Committee Reports. Global Advisory Committee on Vaccine Safety, [accessed 23.10.11]. http://who.int/vaccine_safety/reports/en.
31. World Health Organization. Shan5 vaccine delisted from WHO prequalification, [accessed 23.10.11]. http://who.int/immunization_standards_vaccine_quality/shan5_who-statement-27july2010.pdf.
32. European Medicines Agency. Guideline on procedural aspects regarding a CHMP scientific opinion in the context of cooperation with the World Health Organization (WHO) for the evaluation of medicinal products intended exclusively for markets outside the community. Adopted 17/11/2005, # [accessed 15.02.11]. http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000157.jsp&murl=menus/regulations/regulations.jsp&mid=WC0b01ac05800240d1.