Want China Times, Staff Reporter 2014-01-23
Drug manufacturers in China that have not passed new regulations under the Good Manufacturing Practice for Pharmaceutical Products (GMP) will face closure until they pass the verification process devised by the new GMP regulations, according to the China Food and Drug Administration.
Workers package drugs at a pharmaceutical company in Hangzhou. (Photo/Xinhua) |
Drug manufacturers in China that have not passed new regulations under the Good Manufacturing Practice for Pharmaceutical Products (GMP) will face closure until they pass the verification process devised by the new GMP regulations, according to the China Food and Drug Administration.
Chinese
pharmaceuticals can be divided into two categories — sterile medical products
and non-sterile medical products.
The
administration stated that all the sterile drugs manufactured by existing drug
manufacturers had to meet the requirements of the new version of GMP before the
end of 2013.
As of Dec.
31, 2013, the number of sterile drug producers was pegged at 1,319, with 796
passing the new GMP regulation and 523 trying to meet the new requirements or
waiting to be merged with other companies.
The administration
stated that those who have not met the requirements of the new GMP regulation
could continue operating after they pass, but those who fail to pass the exam
would be closed or merged, according to the Shanghai-based Economic Observer.
Most drug
makers who passed the new regulation are now facing idle capacity because their
capacity had been enhanced to meet standards, said a worker at China Shineway
Pharmaceutical Group.
For drug
producers, trying to meet the new GMP regulation is exerting mounting pressure
as a result of idle capacity, bank loans, development for new drugs and capital
flow.
Non-sterile
medical products, on the other hand, have to meet the requirements of the new
GMP by the end of 2015, said the report.
As of Oct.
2013, only 778 out of the total 3,839 non-sterile drug manufacturers passed the
verification process.
An official
at the China Association of Pharmaceutical Commerce said that at least 1,000
non-sterile medical producers have to be shut down or merged with other firms
after the deadline passes in 2015.
Market
observers are of the view that China's pharmaceutical industry should be
controlled by large pharmaceutical firms, which could help enhance quality,
improve competitiveness and internationalization.
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