China's food and drug authority will thoroughly review all drug
license numbers throughout the country next month, according to a
notice posted on the State Food and Drug Administration's
Website.
The nationwide examination will start on Friday and last 30
days, according to the notice.
It ordered pharmaceutical enterprises to hand in the license
numbers they have acquired by the end of this month by filling
electronic forms via downloaded application software from the
administration's official Website, www.sfda.gov.cn. The local food
and drug authorities must cooperate and organize the review, the
notice said.
This review is in response to a previous misuse of the issuance
of license numbers, the Guangzhou Daily said today.
Earlier media reports have spotlighted several medical
malpractices due to faulty drugs in the past several months. An
injectable antibiotic produced by an Anhui pharmacy company with
poor sterilization procedures killed six around the country.
Some local drug authorities also withdrew dozens of drugs from
their shelves as the drugs failed to pass inspections.
In 2004, the SFDA reviewed 10,009 drug applications, most of
which are generic drugs. However, the US Food and Drug
Administration only reviewed 148 applications during the same
period, the newspaper said.
Each drug category in the government's system has a fixed price,
which caused some pharmaceutical producers to apply for new license
numbers so they could fit outside the government categories, and
therefore, charge much higher prices, the newspaper said.
Several administration officials, who once abused their powers
to issue license numbers, were fired or even sent to prison, the
newspaper said.
Now it reviews applications more prudently and no longer issues
license numbers as easily as before, the report said.
They also plan to revise the rule for drug registration in the
near future on the basis of this nationwide review, the newspaper
said.
(Shanghai Daily August 30, 2006)