Medicinial products

The state food and drug administration (SFDA) circulated and sought feedback on the first draft of the Chinese traditional medical product protection regulation in July 2006. This draft regulation differs from the 1993 regulation of the same name in that:

  • protection is given only to prepared Chinese medicine and not to natural materials;
  • Chinese traditional medicinal products subject to this regulation are not required to be able to treat special diseases; and
  • there is a shorter protection period (seven years, renewable for another seven years if certain conditions are met).

Sale of prescription and OTC drugs

The SFDA is seeking feedback on revised administrative procedures for the classification of prescription and over the counter (OTC) drugs that set out new rules as follows.

  • Prescription drugs must be placed in non-transparent counters and kept separate from OTC drugs.
  • Open-shelf sales of prescription drugs are prohibited.
  • Retailers are prohibited from selling prescription drugs via mail order and/or the internet.
  • Category A prescription drugs and OTC medicines cannot be distributed through giveaways.

The public consultation process concluded on 5 November 2006.

Intellectual property protection

The state intellectual property office (SIPO) promulgated in July 2006 a draft for comment of the third revision to the PRC patent law. The draft does not substantially change the structure of the 2000 regime but revises half of the articles and adds 13 new articles.

The purpose of the revisions include:

  • detailing the provisions adopted in the 2000 patent law in compliance with the requirements of the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights 1994 (TRIPS); increasing consistency between the provisions of PRC patent law and international law; and
  • co-ordinating the provisions of PRC patent law with other PRC regulations.

Product Liability

The state general administration of quality supervision, inspection and quarantine has drafted a product quality warranty regulation that will expand the application of product recalling requirements beyond the motor vehicle industry.