CHINA HEALTH SCIENCES NEWSLETTER
Vol. 3 , No.6 - March 13, 2002
TOPICS THIS ISSUE:
- Guidelines Issued Regulating China's Medicine Market
- Standard Registration Procedure for Imported Drugs
- Chinese Scientists Have Cloned Human Embryos
- Chinese Pharmaceuticals Investing In Brazil
- China to Establish National Center for Disease Control
- China and Pharmaceutical Development Zones
- List of China GMP Facilities (Continued)
Guidelines Issued Regulating China's Medicine Market
The General Office of the State Council recently issued the guidelines on the readjustment and normalization of China's medicine market.
The guidelines, jointly worked out by the Economic Restructuring Office of the State Council, the Ministry of Health, the State Drug Administration and other related departments, require crackdown on producing and selling fake and shoddy drugs.
The guidelines ask for elimination of the sources of fake medicine and severe punishment given to criminals who produce and sell fake medicine.
The illegal sales of medicine should be strictly prohibited in the country, according to the guidelines. Kickbacks and bribery involved in the purchase and sale of medicine will be investigated and handled according to law. Unlawful medicine markets must also be banned.
According to the guidelines, drug administrations across the country must be disconnected from pharmaceutical factories, and should not have economic relations with any company that sells medicine.
The guidelines encourage the creation of a fair competitive environment in China and support superior medicine companies to enlarge their scale of operation through acquisitions and mergers.
The guidelines ask for the shutdown of small medicine manufacturing plants that cause serious environmental pollution, waste resources and do not meet quality standards.
The guidelines stress regulating medicine-selling enterprises, introducing public bidding into the medicine purchasing system, encouraging electronic trade of medicine and strengthening the construction of a medical service network in the rural areas.
Hospital dispensaries will be separated from medical facilities, and hospitals should be prevented from profiting from selling medicine, according to the guidelines.
Medicines have been and will continue to be divided into prescription and over-the-counter categories. Development of new high quality drugs are encouraged. The administration on medicine price will be strengthened, and medical advertisements will continue to be placed under strict supervision.
(Source: Xinhuanet.com)
Standard Registration Procedure for Imported Drugs
Imports of pharmaceuticals are generally restricted by price considerations, strict import regulations, and complex licensing procedures. It is important for any applicant who wishes to enter into the Chinese drug market to understand the general registration procedure for imported drugs. The following registration procedure is set forth based on the relevant provisions of the State Drug Administration.
Step | Procedure | Time Frame |
1. Application Submission | Applicant submits completed Application Form and all required documents to Department of Drug Registration (DDR) of the State Drug Administrative(SDA). | None |
2. Format Inspection | DDR inspects the standardization and completion of the submitted documentation. | 20-30 days |
3. Acceptance and Fee Payment | DDR issues Acceptance and Fee Payment Notice to the applicant. Applicant pays. | 3-8 days |
4. Technical Evaluation | DDR asks SDA Drug Evaluation Division (DED) to carry out technical evaluation. | 3-5 days |
| DED carries out initial evaluation of the documentation, and either rejects the application, or plans an Expert Evaluation Meeting. | 40-120 days |
| DDR holds Expert Evaluation Meeting (twice a years, normally in May and November). | 30-180 days |
| DED reviews outside experts' opinions and combines them with their own in a report to DDR. | 15-60 days |
5. Laboratory Technical Re-examination | National Institute for the Control of Pharmaceutical & Biological Products tests the samples provides by the applicant. | 40-100 days |
6. Approval of Clinical Trial | DDR issues an Approval for Clinical Trial Notice to the applicant. | 20-30 days |
7. Clinical Trial | Applicant conducts clinical trials in the appointed hospitals and submits the results to DDR. | 50-80 days |
8. Integrated Evaluation Result | DED, according to the clinical trial results, submits an integrated Evaluation Report to DDR. | 15-60 days |
9. Report and Approval | DDR submits an Evaluation Report to SDA. | 12-40 days |
| SDA Director signs approval. | 12-40 days |
10. Issue Certificate | DDR produces and issues a Registration Certificate to the applicant. | 5-20 days |
Total Duration | | 265-773 days |
Note: (1) Source: Department of Drug Registration of the State Drug Administrative and Comments on Pharmaceutical written by Qi Bao.
(2) At every step, SDA has the right to reject the application or require the applicant to submit more materials, in which case the time frame may vary.
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Chinese Scientists Have Cloned Human Embryos
Scientists in China said that they recently had cloned dozens of human embryos and have even gone as far as fusing human tissue into a rabbit egg in order to produce stem cells.
The Chinese researchers claimed that their research is far more advanced than British scientists. The US suspects that the Chinese researchers have already harvested stem cells from cloned embryos, which many scientists believe offer hope for a cure for everything from Alzheimer's disease to paralysis. As human embryos in the earliest stage of development are seen as the most promising source of the cells, cloning embryos would produce a steady supply of stem cells.
Professor Lu Guangxiu, a stem-cell researcher at the Xiangya Medical College in Changsha, recently told the Wall Street Journal in an interview about her research, which has not yet been published in a scientific journal. Regarding creating their own stem cell "line," or unlimited source of cells, she said "We're not that far behind any more." She also added that her researchers have been successful in cloning embryos for two years already, with 5 per cent of the dozens that have been produced surviving long enough to have their stem cells harvested. None has developed beyond that stage.
Another Chinese research team led by Sheng Huizhen, a biologist of Shanghai Second Medical University, has used rabbit eggs in its experiments. The team fused human tissue with rabbit egg cells to produce embryos, which were used as a source of stem cells.
Just last week in the United Kingdom, the House of Lords gave the thumbs-up to continue research on cloned humans for the purpose of producing new therapies.
(Source: The Scotsman)
Chinese Pharmaceuticals Investing In Brazil
The Brazil-China Chamber of Commerce is currently actively seeking national partners for 14 Chinese projects in Brazil. According to chamber president Charles Tang, investments in these projects will likely total over US$ 100 million. The projects are mainly in the pharmaceutical area.
It is hoped that the Brazil-China trade fair in Shanghai between April 2 and 5 will start some of these projects off, Tang said. A Brazilian trade mission will be coming to China, headed by Sergio Amaral, Brazil's Minister of Development, Industry and Foreign Trade.
(Source: Gazeta Mercantil Invest News)
China to Establish National Center for Disease Control
China will launch a national center for disease control in order to respond in a highly efficient way to increasing public health problems, according to the Ministry of Health.
The Chinese Center for Disease Control and Prevention, to be based in Beijing, will lead the nation in disease prevention and control, as well as health promotion, said Wang Huanzeng, a ministry official.
The center will be mainly responsible for monitoring risk factors in food, working environment, and school, which could endanger the quality of human life and the environment.
The functions of the center are currently realized by some departments of the ministry and such governmental agencies as the Chinese Academy of Preventive Medicine and the National Health Education Institute.
(Source: Xinhua News Agency)
China and Pharmaceutical Development Zones
Recently, as China undergoes great changes in the area of infrastructure and community development, the pharmaceutical industry has received several major boosts as pharmaceutical zones are cropping up nationwide.
In Jiangsu Province, China's largest "medicine valley" will be built at a cost of RMB 20 billion (US$ 2.42 billion). The "valley" will be located in Wuxi, near Shanghai, and will cover nine square kilometers.
National Colleges and institutes such as Qinghua University and Beijing University, the Chinese Academy of Sciences and the Chinese Academy of Medical Science will work together in the park in the research of bio-pharmaceuticals and modernized traditional Chinese medicine. It is thought the park will be divided into five zones including a bio-tech industrial zone, a bio-tech incubator and an international medical care zone.
In Zhejiang Province, in eastern China, there are plans for a pharmaceuticals materials production base with a total investment of RMB 10 billion (about US$ 1.2 billion) in five years.
It is hoped the Zhejiang project will produce one quarter of the pharmaceutical chemical materials in the international market and make annual profits in excess of US$ 5 billion from exports alone.
The Zhejiang project, which will be funded by the central, provincial and local governments, and private and overseas investors, is hoped to be completed by 2005.
Beijing is already home to a "medicine valley," with more than 600 pharmaceutical factories producing new medicines and bio-engineering products in the Beijing Economic and Technological Development Area (BDA).
After seven years of production, it has truly become an integral part of the pharmaceutical and bio-technology industry in China.
In part due to their "medicine valley," Beijing believes its bio-engineering and pharmaceutical industries will grow at a rate of 30 percent annually. Regardless of the pharmaceutical growth, Beijing is certainly the winner, as it is estimated that the industrial value-added tax from the two sectors will account for 3.28 percent of the city's GDP by 2005.
(Source: China Radio International)
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List of China GMP Facilities (Continued)
Name of Enterprise | Certified Scope |
801. Tianjin Lisheng Pharmaceutical Factory | Tablet, Capsule |
802. Shenzhen Taitai Pharmaceutical Co., Ltd. | Capsule |
803. Shenzhen Taitai Pharmaceutical Co., Ltd. | Tablet, Granule |
804. Suzhou 6th Pharmaceutical Factory | Powder-injection |
805. Zhuhai Likang Pharmaceutical Co., Ltd. | Powder-injection |
806. Shende Shunfeng Pharmaceutical Co., Ltd. | Ointment |
807. Zhengzhou Dacheng Pharmaceutical Co., Ltd. | Oral liquid, Capsule , Granul |
808. Jiangsu Haihong Pharmaceutical Co., Ltd. | Freeze-dried powder-injection |
809. Beijing Juneng Pharmaceutical Co., Ltd. | Tablet |
810. Shenzhen Neptunus Pharmaceutical Co., Ltd. | Freeze-dried powder-injection |
811. Shandong Phoenix Pharmaceutical Factory | Granule |
812. Shandong Phoenix Pharmaceutical Factory | Capsule |
813. Guangzhou Techpool Bio-chemical Pharmaceutical Co., Ltd. | Freeze-dried powder-injection |
814. Guangzhou Techpool Bio-chemical Pharmaceutical Co., Ltd. | Low dose injection |
815. Shandong CP-Freda Pharmaceutical Co., Ltd. | Eye-drops, Injection |
816. Fuzhou Shijixing Pharmaceutical Co., Ltd. | Oral liquid, Capsule, Tablet, Granule |
817. Beijing Zhongguan Pharmaceutical Co., Ltd. | Table, Capsule |
818. Changzhou Bio-chemical Qianhong Pharmaceutical Co., Ltd. | Bulk injection |
819. Aikang Bio-tech (Hangzhou) Co., Ltd. | Diagnose agent |
820. Xinjiang Huashidan Co., Ltd. by Shares | High dose injection |
821. Lianyungang CP-Tianqing Pharmaceutical Co., Ltd. | Tablet, Capsule |
822. Hangzhou Lindanwang Pharmaceutical Co., Ltd. | Capsule |
823. Shandong Sainuojin Bio-pharmaceutical Co., Ltd. | Recombinant human hematopoetin |
824. Shandong Gelanbaike Bio-pharma Co., Ltd. | RhG-CSF injection |
825. Roche Sanwei (Shanghai) Vitamin Co., Ltd. | Bulk Vitamin E |
826. Harbin 6th Pharmaceutical Factory | High dose injection |
827. Changzhou Pharma Yanshen Bio-tech Co., Ltd. | Freeze-dried powder-injection, low dose injection |
828. Henan Yinbang Pharmaceutical Co., Ltd. | Pill, Capsule, Granule |
829. Pharmacia Co., Ltd. | Freeze-dried powder-injection |
830. Guangzhou Longsha Fine-chemical Co., Ltd. | Oral bulk |
831. Jiangsu Yangzijiang Pharma Co., Ltd. by Shares | Granule |
832. Beijing Huajin Pharmaceutical Co., Ltd. | High dose injection |
833. Chengdu Kanghong Pharmaceutical Co., Ltd. | Tablet |
834. Nanjing Meiyui Pharmaceutical Co., Ltd. | Tablet, Capsule |
835. Chengdu Kanghong Pharmaceutical Co., Ltd. | Oral bulk |
836. Yangzhou Yiyang Pharmaceutical Co., Ltd. | Powder-injection, tablet, oral-suspension |
837. Tianjin Xinfeng Pharmaceutical Co., Ltd. | Tablet, Capsule, Powder-injection |
838. Tianjin Pacific Pharmaceutical Co., Ltd. | Tablet, Capsule, Granule |
839. Xian Yuike Bio-products Co., Ltd. | Blood product |
840. Changzhou Huasheng Pharmaceutical Co., Ltd. | Capsule, Tablet |
841. Changzhou Huasheng Pharmaceutical Co., Ltd. | Granule |
842. Zhejiang Dade Pharmaceutical Co., Ltd. | Tablet, Capsule, Granule, Oral liquid |
843. Lanzhou Fozi Pharmaceutical Factory | Pill, Tablet, Capsule, Granule |
844. Shanghai Baite Medical Products Co., Ltd. | High dose injection |
845. Tianjin SB&F Pharmaceutical Co., Ltd. | Ointment |
846. Bofu-Epson (Tianjin) Pharmaceutical Co., Ltd. | Powder |
847. Beijing Youhua Pharmaceutical Co., Ltd. | Tablet, Suspension |
848. Beijing Youhua Pharmaceutical Co., Ltd. | Capsule, Ointment |
849.Shandong Dongejiao Co., Ltd. by Shares | Moisture, Glue |
850. Chengdu Qingshan Pharmaceutical Co., Ltd. | High dose injection |
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