Mark van Ooij is scientific director, Johnson & Johnson Innovative Medicine, Leiden, The Netherlands.
Reliance-Based Waivers Become the Predominant Trend in In-Country Testing of Pharmaceutical Products
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as well as the improved information exchange between national regulatory authorities, in-country testing is considered outdated and redundant in many cases.