context: Policies to develop the generic medicine industry exist but are fragmented. State Council issued 'Guiding opinions on quality consistency evaluation of generic medicine' in 2016 to encourage manufacturers to pay third-party review agencies to conduct evaluations. By end 2017, 55 percent of the 423 medicine reviews that Centre for Drug Evaluation (CDE)'s had prioritised were for generic medicines.
State Council published ‘Opinions on reforming and developing generic medicine supply and usage policies’ 3 April 2018, providing supportive policies on purchasing, insurance, and taxation for high-quality generic medicines. The Opinions call for
- providing manufacturers with supportive policies for consistency evaluations
- improving the quality of raw materials and packaging
- upgrading manufacturing
- speeding up marketing approval processes for generic medicine
- setting up life cycle quality control and management systems
- including high-quality generic medicine in health insurance lists
China's market is flooded with cheap inferior medicines that lack the potency of their brand-name equivalents. Health insurers are paying for these expensive imported medicines even though their patents are expired and domestic manufacturers could produce generic alternatives, says Yicai, arguing that high-quality generic medicine will eventually replace imported brand-name medicine.
Government is trying to transform generic medicine from a big industry to a strong one, reports Yicai, explaining that 95 percent of China's total 17,000 approved medicines are generic and 60 percent of China's total 4,376 pharmaceutical firms produce generic medicines.