Emerging markets and emerging agencies: A comparative study of how key regulatory agencies in Asia, Latin America, the Middle East, and Africa are developing regulatory processes and review models for new medicinal products

Drug Information Journal

Volumn 43, Issue 3, 2009, Pages 349-359

  McAuslane, Neil ^a   Cone, Margaret ^a   Collins, Jennifer ^b   Walker, Stuart ^a  

^a CMR International Institute for Regulatory Science   (United Kingdom)

^b CMR Institute for Regulatory Science   (United Kingdom)

Author keywords

Asia, Latin America, Middle East, and Africa; Emerging markets; New medicines; Quality measures; Regulatory review

Indexed keywords

NEW DRUG;

ARGENTINA; BRAZIL; CHINA; COMPARATIVE STUDY; CONTROLLED STUDY; DRUG APPROVAL; DRUG INDUSTRY; DRUG MARKETING; EGYPT; GOOD MANUFACTURING PRACTICE; INDIA; INDONESIA; INFORMATION PROCESSING; MALAYSIA; MEXICO; PRACTICE GUIDELINE; PRIORITY JOURNAL; PRODUCT DEVELOPMENT; QUALITY CONTROL; REVIEW; RISK ASSESSMENT; SAUDI ARABIA; SINGAPORE; SOUTH AFRICA; SOUTH KOREA; TAIWAN; TOTAL QUALITY MANAGEMENT;

EID: 67549137555     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286150904300314     Document Type: Review

References (4)

1. McAuslane N, Cone M, Collins J. A cross regional comparison of the regulatory environment in emerging markets. CMR International Institute for Regulatory Science R&D Briefing No. 50, February 2006. Available at: http://www.cmr.org/institute/PDF/RD50.PDF.
2. Walker S, Cone M, Collins J. The emerging markets: regulatory issues and the impact on patients' access to medicines. CMR International Institute for Regulatory Science Workshop Report, April 2006. Available from Institute@cmr.org.
3. Walker S, McAuslane N, Cone M, Collins J. Emerging markets: models of best practice for the regulatory review of new medicines. CMR International Institute for Regulatory Science Workshop Report, March 2008. Available from Institute@cmr.org.
4. Cone M, McAuslane N. Building quality into regulatory activities: what does it mean? CMR International Institute for Regulatory Science R&D Briefing No. 46, June 2006. Available at: http://www.cmr.org/institute/PDF/RD46. PDF.