1. Reliance-Based Waivers Become the Predominant Trend in In-Country Testing of Pharmaceutical Products
- Author
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Garbe, Joerg H.O., Conti, Tais, Mcgoldrick, Mic, Jacobs, Maria G., Juvin, Philippe, Mlynarczyk, Peter J., Ooij, Mark Van, Roenninger, Stephan K., and Tyers, Gerald
- Subjects
United States. Food and Drug Administration -- International economic relations ,Vaccines -- Quality management ,Quality control -- International trade ,Pharmaceutical industry -- International economic relations ,Quality control ,Business ,Pharmaceuticals and cosmetics industries ,World Health Organization - Abstract
This study reviews changes in in-country testing (registration testing, import testing) requirements and analyzes current trends. In the context of international harmonization of good practices and standards as well as the improved information exchange between national regulatory authorities, in-country testing is considered outdated and redundant in many cases. More and more countries acknowledge the limited value of in-country testing compared to the benefit of full or partial testing waivers. Analyzing the changing testing requirements, the authors find that a predominant trend is waiver schemes based on unilateral reliance on reference countries with a mature regulatory system., In 2015, an overview of in-country quality control (QC) testing requirements for pharmaceutical products--the term 'pharmaceutical product', or simply 'product', will be used in this article to refer to small [...]
- Published
- 2024
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