When a new, patent drug entered into the market overseas, patients in need of them in China had to wait for a long time－several years, in many cases－so the drugs could be available on the domestic market, due to lengthy and stringent approval procedures adopted by the drug regulators.
With a series of measures adopted by China's top drug regulator over the past few years, the waiting time has been greatly reduced. A revised law on drug administration is expected to further aid patients' access to badly needed drugs and encourage domestic research and development of new drugs, according to officials and experts.
In addition to stricter supervision over the pharmaceutical sector to ensure safety and quality of drugs, the Drug Administration Law, adopted in December, include a number of new regulations that encourage research and innovation of new drugs, and accelerating their approval and availability in the market, Liu Pei, chief of policy and law at the National Medical Products Administration, China's top drug regulator, said.
The law states that priority should be given to badly needed drugs in their evaluation and approval, such as drugs that can prevent and treat major infectious diseases and rare diseases, and drugs for children.
The law also authorizes simplifying approval procedures for drugs to treat serious diseases that lack effective means of treatment, as long as clinical trials of the drugs have shown they are effective and their value in clinical use are foreseeable.
Source: China Daily
