China practices data protection system for drugs

2008-07-18 02:06:00 GMT       2008-07-18 10:06:00 (Beijing Time)       Xinhua English

BEIJING, July 18 (Xinhua) -- China earnestly fulfills its commitments to the WTO and implements a data protection system for drugs, said a white paper published on Friday by the Information Office of the State Council.

The white paper, titled Status Quo of Drug Supervision in China, said to prevent generic drugs from freely using the research and development data of new drugs, and therefore hindering the motivation for inventing new drugs, China earnestly fulfills its commitments to the WTO and implements a data protection system for drugs.

The Regulations for the Implementation of the Drug Administration Law of the People's Republic of China amended in 2002 stipulates that undisclosed data of drug studies and others which are independently acquired and submitted by drug manufacturers or sellers who eventually obtained production or marketing approval for the drugs in question which contain new chemical entities enjoy a six-year protection period, the paper said.

Furthermore, the state implements special evaluation and approval procedures to encourage the invention of new drugs and the development and research of new drugs for treating difficult, complicated and severe diseases, according to the paper.

It said that the special procedures are applicable to the following new drugs: active ingredients which are extracted from plants, animals, minerals and other materials and have not been marketed in China, and preparations containing these ingredients; newly discovered medicinal materials and their preparations; drugs made of chemical materials which have not been marketed domestically or internationally and their preparations and biologicals; new drugs with obvious clinical advantages for treating AIDS, malignant tumors and rare diseases; and new drugs for diseases without effective treatment.

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