State Drug Administration, Administration and Supervision of Pilot Pharmaceutical Electronic Commerce Projects Measures

Issued: June 26 2000
Effective: as of date of issue
Iterpreting Authority: State Drug Administration
Applicability: Pharmaceutical Electronic Commerce is defined as the carrying out and completion of all types of commercial activities or related service activities by the electronic exchange of data and information through information network systems by producers, traders or users of pharmaceuticals (Article 2).
For purposes of these Measures, the definition of "pharmaceutical projects" also includes medical machinery, packaging materials that come in direct contact with medicines and excipients (Article 31).

Main contents: Part One states that the State Drug Administration will supervise pilot projects in conjunction with the departments responsible for supervising pharmaceuticals at the various levels of government, as well as with the departments that regulate commerce and information products (Article 3).
Part Two sets out the guidelines for establishing whether an organization is qualified to maintain a website devoted to commerce in pharmaceuticals. The establishment of such a website must be authorized by the State Drug Administration (Article 5). A website must fulfil certain conditions (Article 6); specifically, the establishing organization must possess sufficient resources to ensure long-term service; the website must be established either by an authorized retailer of pharmaceuticals or by a drug wholesaler that operates in conjunction with an internet service provider; and key positions must be occupied by individuals with professional pharmaceutical training. Producers, retailers or medical-service providers intending to use the website for electronic commerce must sign an agreement with the website (Article 8).
Part Three deals with supervision of retail enterprises that engage in commerce through a website. Retail trade can only be in products specified as non-prescription drugs by the State Drug Administration (Article 15). Part Four deals with supervision of manufacturing enterprises that engage in trade on the internet, and states that a licensed producer may produce pharmaceuticals once it has signed an agreement with the website and provided it with original copies of the documentation authorizing the production, retail and import of the product in question (Article 21). Part Five deals with the supervision of work units purchasing pharmaceutical products through a website. Authorized medical organizations may purchase pharmaceuticals once they have signed an agreement with the website (Article 23). Intermediary agencies that engage in centralized purchase by tender may purchase medical products through the website after they have signed an agreement with the website and have gained authorization from the State Drug Administration (Article 24).
Related legislation: PRC, Administration of Pharmaceuticals Law