The Regulatory Review Process in South Africa: Challenges and Opportunities for a New Improved System-Reference-Cited by-同舟云学术

The Regulatory Review Process in South Africa: Challenges and Opportunities for a New Improved System

Published:2018-07 Issue:4 Volume:52 Page:449-458
ISSN:2168-4790
Container-title:Therapeutic Innovation & Regulatory Science
language:en
Short-container-title:Ther Innov Regul Sci

Author:

Keyter Andrea,Gouws Joey,Salek Sam^ORCID,Walker Stuart

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Public Health, Environmental and Occupational Health,Pharmacology, Toxicology and Pharmaceutics (miscellaneous)

Link

http://link.springer.com/content/pdf/10.1177/2168479018776649.pdf

Reference15 articles.

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2. Hill S, Johnson K. Emerging challenges and opportunities in drug registration and regulation in developing countries, DFID Issue Paper, 2004. http://heart-resources.org/wp-content/uploads/2012/10/Emerging-challenges-and-opportunities-in-Drug-registration-and-regulation.pdf. Accessed November 5, 2017.

3. Cone M, Walker S. Workshop Report: Building Quality Into Regulatory Dossiers and the Review Process: Knowing and Meeting Customer Expectations. Surrey, UK: CMR International Institute; 2005.

4. Cone M, McAuslane N. R&D Briefing 46: Building Quality Into Regulatory Activities: What Does It Mean? Epsom, UK: CMR International Institute, 2006.

5. Al-Essa R, Salek S, Walker S. An appraisal of good regulatory review practices in the Gulf Cooperation Council States. Drug Info J. 2012;46:57.

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