Shanghai's move to further streamline introduction of new drugs welcomed

Shanghai will leverage its strong position in fostering innovation to encourage new drug research and development and to speed up the introduction of innovative medicines, officials said.

Pharma company executives shared their views on how new rules and improvements will help innovative drugs to be introduced to the market at a faster pace.

Vice director of Jinshan District, Wang Yiyang, told the China Innovation Pharmaceutical Forum yesterday that the district will add about nine square kilometers of industrial land by the end of 2035 as part of the city's plan to optimize industry layout.

Jinshan District is already home to a number of pharmaceutical companies including Fosun Pharma, Wuxi AppTec, Baxter and China Resources Pharmaceutical Group. 

"We will also strengthen collaboration with Zhangjiang Hi-Tech Park to allow drug research and development results to be quickly put into commercial manufacturing at production sites in Jinshan," deputy general manager Huang Tao of Jinshan Industry Investment Development Limited Company said.

China is aiming to become an “innovation nation” by 2020, an international leader in innovation by 2030, and a world powerhouse in scientific and technological innovation by 2050.

The China National Medical Products Administration has stipulated responsibilities under the market authorization holder (MAH) scheme, which allows start-up companies to file for new drug launches without their own manufacturing facilities.

Senior vice president Fu Xiaoyong of STA Pharma, a WuXi AppTec company which focuses on small molecule pharmaceutical development and manufacturing, said that the MAH scheme has also created high demand for contract manufacturing organizations to live up to global quality standards.

"Contract development and manufacturing organizations shall strengthen manufacturing quality control measures, which helps to shorten the time required for new drug launches," he added.

The trial program will help start-up companies to save the cost of building up their own manufacturing facilities and to outsource production to third party service providers.

Hutchison Medi Pharma senior vice president Wu Zhenping noted that collaboration with contract development and manufacturing organizations helps the company to focus on its core business of identifying new chemical compounds and drug candidates.