It’s been 2 yrs since China rolled out its pilot marketing authorization scheme, which allowed the license holders of a drug to sell in China using a contract manufacturer, instead of manufacturing the drug themselves. The scheme has progressed in streamlining drug approvals for the China market to give Chinese patients access to more drugs, more quickly and more affordably. The system coordinates with international standards for drug safety to keep patients risk low, while stimulating innovation, and speeding patient access to life-saving therapies.
Yu Lu, Vice President Of Business Operation at Wuxi STA Pharmaceuticals says that the scheme has resulted in a “seamless chemistry, manufacturing and control working process”. According to him the scheme allows for a quicker drug development process and speeds up timelines for customers.
The scheme has several advantages for international companies as well as the companies looking to enter the Chinese market can now use a contract manufacturer to progress their own products through clinical development rather than having to built a manufacturing facility for themselves or use the import route, providing lower barrier to reach the market and bringing in innovative products.
MAH is currently being piloted in 10 provinces and municipalities across China and will be rolled out nationally by the end of 2018.