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)
