Through proper implementation of ICH Q12 tools and enablers, the industry could manage CMC changes effectively under a company’s pharma quality system with less need for oversight prior to implementation.
This article outlines six recent regulatory changes in China intended to protect patient safety as well as reduce regulatory burdens and minimize delays. Understanding what efforts are being made to facilitate market entry is critical for any company considering expansion into this challenging but flourishing area of the pharmaceutical industry.
Building a bioprocessing facility is usually a complicated process and requires partnering with not only drug developers, but also many different experts in various industries. A commercial-stage biotechnology company with a large-scale biological manufacturing facility currently under construction in Guangzhou, China, can attest to these challenges.