A new national drug management regulation that goes into effect on
Sunday will decentralize regulations of the pharmaceutical
industry, impose clinical trials on drugs that have never been sold
in China before, and increase penalties on those selling illegal
medical products, according to the Shanghai Drug Administration
Bureau.
In
the past, any drug being manufactured in China for the first time
had to undergo clinic trials, but drugs not made here could be
imported into the country without similar trials.
The new regulation will ensure all drugs new to China, whether
produced here or imported, are tested in clinical situations, the
bureau announced yesterday.
In
order to help develop the domestic pharmaceutical industry, the new
legislation will change patent laws on drugs to bring them into
line with international standards.
Previously, when a new drug first entered China its manufacturer
could apply for patent protection for four to 12 years, even if the
drugs 20-year international patent had already run out. Usually,
these medicines were granted eight years protection.
Under the new rules, once a product's 20-year patent runs out it
will receive no extra copyright protection in China.
"Now, domestic drug manufacturers no longer have to wait another
eight years to employ foreign counterpart's new ideas after the
patent has expired, which could put our pharmacy industry in line
with international practices," said Wang Longxing, the bureau's
director.
The new rules also impose stiffer penalties on the selling of fake
drugs for pregnant women and children.
In
order to better supervise the drug industry, the central government
will allow provincial authorities to approve production and sales
of most pharmaceutical products. Blood products, biological
products, radiative drugs and anesthetics will still be controlled
solely by national authorities.
(eastday.com September
13, 2002)