Rule to Exempt Unapproved Drugs that are Imported in Tiny Amounts

2019/08/28

Drugs legally available overseas but unapproved by Chinese drug authorities will no longer be deemed fake drugs, according to a revised law passed by China's top legislature on August 26.
 
Importing "a little amount" of such drugs for use that does not cause health damage or interfere with treatment for patients can be exempt from legal consequences, according to the revised Drug Administration Law, approved by the National People's Congress Standing Committee. 
 
According to the existing law, unapproved drugs, whether they are effective or not, are classified as fake medicine. Selling such drugs may result in a prison sentence of up to three years, even if there are no serious consequences, with harsher penalties possible in cases of serious consequences, such as death.
 
Yuan Jie, director for the administrative law department of the Legislative Affairs Commission under the NPC Standing Committee, said the revision is "a response to public concern".
 
Many effective drugs used for serious diseases that are already available overseas have not gained domestic approval and are not available on the domestic market, resulting in many patients buying such drugs from overseas or through dealers engaged in legal risks.
 
Source: China Daily