CHINA LEX PHARMA LAW NEWSLETTER
Vol. 2 , No. 4- January 31, 2001
TOPICS THIS ISSUE:
- Limited Advertising for Prescription Drugs
- China to Keep a Closer Eye on Adverse Drug Reactions
- New Regulations for Online Drug Information Providers
Limited Advertising for Prescription Drugs
In a move to further regulate the advertising tactics of pharmaceutical manufacturers, the Chinese government has released a preliminary list of drugs banned from advertising in the country's mass media.
The State Administration for Industry and Commerce, responsible for the regulation of advertising, and the State Drug Administration jointly issued the first list. The complete list will be released gradually over this year.
Prescription drugs will no longer be allowed to advertise in mass media publications, although advertisements in medical publications will still be permitted.
In addition to the list, the two administrations have required that local government agencies conduct strict investigations of advertisements and their applications. Applications for advertisements of prescription drugs will no longer be accepted after February 1.
(Source: ChinaOnline)
China to Keep a Closer Eye on Adverse Drug Reactions
The State Drug Administration plans to implement a regulation standardizing the reporting and monitoring of adverse reactions to pharmaceuticals.
Measures to improve the system include increasing the number of monitoring and reporting centers at both the national and provincial levels, and creating expert committees to facilitate the system's implementation. Also in the plans is an information-exchange system over the Internet to improve the flow of current information between China and international health organizations such as the WHO.
Although hospitals and pharmaceutical manufacturers are currently required to report adverse medical reactions to products, many are reluctant to do so for fear of affecting pharmaceutical sales.
China's first monitoring and reporting center for adverse medical reactions was established by the Ministry of Health in 1989.
(Source: China Daily)
New Regulations for Online Drug Information Providers
Online drug information providers will be subject to closer monitoring by the Chinese government. Regulations issued by the State Drug Administration in January will take effect on February 1.
In addition to categorizing the online services into commercial and non-commercial categories, the regulations also require the inspection and approval of all online drug information providers.
Providers must have a mininum of two government-authorized drug management professionals familiar with relevant laws and regulations, in addition to taking measures to ensure that the information provided online is accurate, safe and legal.
(Source: ChinaOnline)
Lehman Lee & Xu
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