Lehman, Lee & Xu – China’s Leading Pharmaceutical Law Firm Newsletter

This is the second installment in the 2-part review of China's new Drug Registration Procedure (DRP) which came into effect on December 1, 2002.

The DRP has also changed the approval system and management of drug quality and imports, and establishes systems of drug re-registration and monitoring.

The DPR abolishes the market protection of 6 to 12 years which was previously available for a newly-certificated drug and replaces it with a system under which newly-marketed products are to be monitored for a period not exceeding 5 years.

Accordingly, the State Drug Administration SDA has established different monitoring periods for different kinds of drugs, namely:

- 5 years' monitoring for products which are being introduced into China for the first and that have not yet been previously marketed overseas;

- 3 to 5 years for the first manufacture and then introduction of a product in China which has been previously marketed overseas;

- 3 to 4 years for products which are newly-certificated for manufacturing and then marketing in China, unless either of the above conditions apply; and

- 1 to 3 years for a product which has been administered as a new drug for manufacture and then marketing in China.

China's Pharmaceutical Industry 2003 Growth Projected at 15%

China's pharmaceutical sector is expected to grow by 15% in 2003. This growth is expected to come due to increasing consumption according to a research report by the Guotai Junan Securities Co Ltd.

According to the report, China's drug sales reached US$ 6.8 billion in 2002, and are expected to rise to US$ 14 billion in 2005 and to US$ 24 billion in 2010.

Guo Enlai, a contributor to the report, said as China has committed to further reform of its medical insurance system in the next several years, those insured by medical insurance are expected to increase to 300 million from the current 160 million people, resulting in more consumption of medical products.

According to a census conducted in 2000, population aged over 65 was 88.12 million, and is forecast to grow 3% annually in the next three years, Guo said. "As people are nowadays more inclined to take drugs and tonics made of natural materials, traditional Chinese medicine is likely to grow strongly in the next few years", he said.

But due to the price cuts in drugs by the regulators, the average profit ratio of mainland pharmaceutical producers has fallen to 8% in 2002, and is expected to futher decrease in the next several years, he said.

China's pharmaceutical industry recorded an industrial output value of RBM 289.54 in the first 11 months of 2002, up 17.4% on the previous year, with total value-added output up 15% at RMB 85.27 billion.

China to Provide Clean Needles for Drug Addicts

Major cities in China will soon provide clean needles to drug addicts in a bid to combat the rapid spread of AIDS.

The pilot program, which will see drug treatment centers set up will allow addicts visiting the clinics to receive medical treatment as well as clean syringes, according to Wu Zunyou, from the National Center for AIDS/STD (sexually transmitted disease) Control and Prevention.

Previously, only Guangdong province made clean needles available to intravenous drug users by putting them on sale at designated pharmacies in response to reports that a majority of local addicts share their needles. This sharing of needles was partly due because needles had been hard to come by and the government had not wanted to be seen as promoting drug use by handing out free needles.

If the pilot project proves successful, the Center and the Ministry of Health will open clinics across the country within the next five years, Wu said.

Liver Cancer Prevention Center Opens in Beijing

Organized by the Beijing Branch of the Chinese Medical Association, eight hospitals in China's capital have combined efforts to set up a clinic offering preventative treatment for liver cancer.

Liver cancer is now the third biggest killer of all cancer patients in the world and the number of liver cancer patients in China, including those who died of the disease, is 500,000 on average a year, accounting for more than half of the world's total. Most of them are in the 40-49 age group.

The liver disease is characterized by its quick development and difficulty in prevention and treatment.

Therefore, prevention among people at risk is of great importance, a Chinese medical expert said.

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Chinese Version of Viagra Appears in Shanghai

Jianyang Capsule, a traditional Chinese medicine (TCM)-style Viagra, has been put on sale in the drug stores in Shanghai.

It is the first time that TCM medicine for erectile dysfunction (ED) has been made available outside hospitals.

Some Western drugs, including Viagra, have been in China for several years but as non-OTC medicines, they are only allowed access in hospitals.

According to Lu Zuqiang, sales manager of the Guizhou Jianxing Medicine, the Jianyang Capsule is the first domestic ED TCM drug approved by the government and they hope capture a large share of the market.

Statistics show that one quarter of Chinese males suffer from physiological or psychological sexual dysfunction which causes problems such as ED.

Due to a more indulgent lifestyle causing cardiovascular disease, high blood pressure and diabetes, the incidence in the coastal areas where the economy is more developed is two to three times higher than those in inland regions.

Last year, Viagra saw a sales volume of nearly RMB 50 million (US$ 6 million) in China. The annual sales volume of medicines coping with ED is estimated at RMB 2 billion (US$ 241 million) in China.

China to Continue Emphasis on Biotechnological Research

The Chinese government will continue to support biotechnology as one of its top priorities for national economic and social progress, said Vice-Minister of Science and Technology Li Xueyong.

Li said during the tenth Five-Year Plan period (2001-2005), the central government would invest RMB 6 billion (US$726 million) in basic and application research in the life sciences, as well as in some high-tech research and development. Meanwhile, local governments, new and high-tech enterprises, venture investment and various funds would also contribute in this regard, Li said.

With biotechnology breakthroughs playing an increasingly important role in medicine, health, pollution treatment, clean energy and chemical products development, Mr. Li listed the three principles for China's biotechnology development as strengthening technological research and product development, promoting the industrialization of biotechnology, and ensuring bio-safety.

Mr. Li said the life sciences, biotechnology and the biological industry played a crucial role in China's economic and social progress.

CHINA HEALTH SCIENCES NEWSLETTER

China's Pharmaceutical Industry 2003 Growth Projected at 15%

China to Provide Clean Needles for Drug Addicts

Liver Cancer Prevention Center Opens in Beijing

Chinese Version of Viagra Appears in Shanghai

China to Continue Emphasis on Biotechnological Research

Lehman Lee & Xu