(Xinhua)
Updated: 2007-12-12 19:37

Chinese and US regulators will jointly supervise bilateral trade in drugs and medical devices, starting with 18 items, said a spokeswoman with China's State Food and Drug Administration (SFDA) in Beijing Wednesday.

The SFDA signed an agreement with the US Department of Health and Human Services (HHS) Tuesday, "a step forward to provide safe medicines and devices for the people of both countries," Yan Jiangying told a press conference.

In the first stage, China will list eight types of drugs and medical devices that the US government should focus on, while the United States would designate 10 items on a list for China, she said.

"The lists will expand, based on the effect of our work in the first stage," she said.

Companies in either country that are involved in the production and export of listed items would be asked to register and provide relevant information to the authorities.

The two sides also adopted other policies, including provisions for joint investigations, recall of substandard products, regular high-level meetings, exchange of information about amendments to relevant laws and regulations, exchange of new technologies and joint personnel training.

"Different rules and standards of drug safety between the two countries won't hold back cooperation. We hope to improve mutual understanding and trust with our US counterpart and stand together against difficulties and challenges," Yan said.

China also hoped to cooperate with other countries and territories to improve the management of drug quality, she said.

China is one of the world's largest exporters of active pharmaceutical ingredients. The United States and European Union are major importers.

The list that China is sending to the United States has six medicines: insulin synthesis for diabetes; lysine ester and salt (cancer treatment); cefoperazone sodium (antibiotic); paclitaxel injections (chemotherapy); penicillin, and blood test reagents (reactive agents). The two medical devices on China's list are intraocular lenses and artificial pacemakers.

"We have run through the catalog of imported medical products from the United States and picked those with the largest import volume and highest risk," Yan said.

On the US list there are eight drugs or pharmaceutical items. These include gentamycin sulfate (for cancer); atorvastatin (for cholesterol); sildenafil (the active ingredient in Viagra); dietary supplements to treat erectile dysfunction and improve sexual performance; human growth hormone; an anti-viral drug, oseltamivir; an antibiotic, cephalosporin, and glycerine (a common ingredient in medical, pharmaceutical and personal care items). The US side listed two devices; glucose meters and condoms.

The two sides have 30 days after the agreement takes effect to exchange full lists of registered pharmaceutical makers and their product catalogs.

A bilateral working group will be founded under the agreement within 30 days, with the first meeting to be held within the next 60 days.