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Unregistered Drug Makers Forbidden after July 1, 2004

Drug and raw drug materials enterprises and workshops in China that do not reach Good Manufacturing Practice (GMP) standard will have to stop production on July 1, 2004, according to a circular recently issued by the State Food and Drug Administration of China.

 

However, the circular says, approved by provincial drug authorities, quality drugs produced before June 30, 2004 shall remain marketable and usable before their expiration date.

 

Applications will be finished before December this year.

 

Drug products produced by unqualified manufacturers have caused many medical accidents and legal action, which has caused serious concern among the public, drug authorities and legislators.

 

The GMP standard consists of the basic rules and requirements manufacturers must follow to ensure drug quality.

 

According to China's drug administration law, drug enterprises must operate in line with the GMP requirements set by the state drug authority and enterprises with out-of-date facilities should be phased out gradually.

 

(Xinhua News Agency November 3, 2003)

 

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