J&J: Regulatory delays in China are stymying drug approvals
- Speaking at the World Economic Forum in Davos, Switzerland. Paul Stoffers, Chief Scientific Office at Johnson & Johnson (J&J), discussed the fact that getting a product approved in China can take as long as seven years. J&J is not alone in facing this problem in China.
- Stoffers asserts that China's regulatory process for getting drugs approved is a bigger problem than economic factors for pharma companies looking to gain product approvals and market drugs in China.
- J&J, which is based in New Brunswick, NJ, is the biggest maker of health products in the world.
The R&D-Based Pharmaceutical Association Committee (RDPAC) has reported that the Chinese regulatory authorities have added an additional administrative procedure that must be handled before a drug can ne approved. In fact, according to RDPAC, at least 34 drugs from multinational pharmaceutical companies have been stalled as a result of this requirement. RDPAC estimates that the average time-to-approval in China has doubled from roughly two to four years.