Revised China Drug Regulation Sets Back IPR Protection – Experts
Long-awaited revised draft of China’s main drug registration regulation has legal experts wondering whether the China FDA is opening the flood gates to generic copies of new drugs due to a loosening of patent linkage provisions. Lack of provisions on review time limits and multiregional trials also disappoint some, although new OTC moves may be positive.
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Surprise announcement by China FDA to roll out an electronic common technical document system by year-end is causing jitters in the pharma industry, but other moves to raise product quality and strengthen patent linkage seem more positive for manufacturers.
If you missed some of the many significant events in China’s policy and regulatory landscape in 2016, here is your opportunity to catch up on month-by-month developments.
In a fundamental shakeup of chemical drug classifications in China, foreign imported products are now in a class of their own while domestic drugs will be considered generics unless they are NCEs or have new formulations or indications. The changes are set to change the competitive landscape in profound ways, industry observers predict.