Innovation is key

Free Trade Zone now known for pharma manufacture and as mainstay of Pudong New Area’s economy

Shanghai released a framework plan to emphasize the role of innovation.

Core innovation capability of the China (Shanghai) Pilot Free Trade Zone has been largely enhanced since the municipal government released a framework plan to link the FTZ with Shanghai Zhangjiang National Innovation Demonstration Zone in late November last year.

Officially launched in 2013, Shanghai FTZ expanded in April 2014. By then, Zhangjiang was already a link.

As a manufacturing base of biological medicine for Shanghai and an industry leader in China, Zhangjiang has played an important role in shaping the FTZ’s technological innovation against the backdrop of the joint development framework plan.

Its role in the pilot program as a marketing authorization holder system of drugs is significant.

Under the marketing authorization holder system, which is widely adopted in developed markets, drug companies’ marketing and production processes are separated. A marketing authorization holder can outsource the production process to different pharmaceutical companies.

However, under China’s current Drug Administration Law, marketing authorization and production are combined.

This means, a pharmaceutical company should be in charge of the research and development of drugs as well as production.

The R&D ability and production capability thus remained underdeveloped or contained.

From August last year, 10 provinces and cities started their trial programs of the holder system.

German pharmaceutical giant Boehringer Ingelheim in Shanghai was one of the first companies to implement it.