The amendments to the Law of the People's Republic of China on Pharmaceutical Administration will help strengthen the supervision of medicine and ensure the safety and effectiveness of drugs, according to Zheng Xiaoyu, director of the State Drug Administration, at a press conference in Beijing yesterday.
The law aims to ensure the quality of medicine and safeguard public health.
The official requested that drug supervision watchdog staff act strictly in accordance with the revised law and regulate their own behaviour.
The law, which went into effect in 1985, was not able to meet the requirements of China's new situation and problems in research, production, sale and use of medicine. The nation's upcoming entry into the World Trade Organization (WTO) also calls for changes, according to Zheng.
Adopted in February by the National People's Congress after more than two years since its drafting by the administration, the amended law, with 10 chapters (106 items), will be effective as of December 1, 2001.
The revised law nearly doubles the number of items on the original one, which had 60 items. Fifty-eight of the 60 original items have been revised, said Zheng.
The revised law regulates and strengthens supervision over imported medicine to meet the conditions of China's upcoming entry into the WTO.
Foreign medicines are authorized to enter the Chinese market only after passing an examination by the administration and receiving a registration certificate, according to the revised law.
The administration will check the submitted technical data and relevant documents and conduct clinical experiments when necessary, according to the administration.
Foreign medicines in the Chinese market without registration certificates will be regarded as counterfeit medicines.
The revised law also ordains that foreign medicines have to be imported through ports authorized by the State Council. Companies that import medicines from abroad are required to receive registration and approval from local drug watchdogs.
Local drug supervision departments should randomly examine imported drugs, according to the administration.
Punishment of illegal behaviour regarding the production and sale of counterfeit medicine is strengthened in the revised law.
Stipulations on advertising, pricing and kickbacks have been added to the revised law to protect the interests of consumers.
Prescription medicine is forbidden from advertising on the mass media by law.
(China Daily 03/30/2001)
