CHINA LEX PHARMA NEWSLETTER
Vol. 1, No. 24 - November 2, 2000
Lehman, Lee & Xu
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Drug Research Institutes to File with SDA
China's State Drug Administration (SDA) recently issued a circular requiring all pharmaceutical research institutes to register with SDA by the end of March 2001. If drug institutes have not filed by then, their applications for drug clinical trials and manufacturing will not be accepted by SDA.
The information to be filed at SDA by drug institutes should include the following: legal status and necessary corporate organization; competent research staff; research sites and equipment corresponding to their research fields. A further requirement is that the number of beds for patients in the medical institutions conducting clinical trials should not be less than 500.
It is estimated that there are several thousand drug research institutes in China. The purpose of registration is to promote the standardization for processing and improving new drug research.
Source: Health News
GLP Certification to be Conducted in China
It is reported that China will issue the Good Laboratory Practice (GLP) manual and conduct GLP certification next year to ensure the truthfulness and reliability of drug research materials.
China started GLP on a trial basis in 1993, but laboratories have yet to conform to the standards. The reasons for this slow implementation are as follows: (i) the perception that GLP management is an additional burden and costs time and money; and (ii) the belief that research has been of sufficiently high quality even without GLP. However, there are many problems in the research of new drugs, such as incomplete laboratory records, loss of original records, inaccuracy of observation records, and failure to meet environmental standards. These problems have had a negative impact on the research level of new drugs and made international placement of China pharmaceuticals difficult.
Source: Health News
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Drug E-Commerce Companies Selected
SDA has selected eight pharmaceutical companies to conduct online drug sales on a trial basis, since the issuance of the Rules on Administration of Drug E-Commerce by SDA on June 26, 2000.
The eight Chinese companies are: China Pharma (Group) Company, Guangdong Kangli Pharma Co., Ltd., Shanghai Municipal Pharma Shareholding Co., Ltd., 999 Group, Shanghai Fuxing Industrial Shareholding Co., Ltd., Shenzhen Municipal Yizhi (Group) Company, Fujian New Continental Co., Ltd., and Sichuan Zhong-yao-tong E-Commerce Co., Ltd. Source: China Pharma News
Thirty-five Companies Win Official Bid to Implement State High-Tech Discoveries
The Chinese government has selected 35 companies that will be entitled to exploit State-sponsored high-technology discoveries. This is the second group of companies chosen under this initiative, which is designed to get new technologies onto the market as quickly as possible.
The companies include North China Pharmaceutical Group, Qinghua Unisplendour Corporation, Hisense Group and Shenzhen Sangxia Computer & Human Intelligence Development Corporation.
The discoveries originate from State-sponsored programs within the Ministry of Science and Technology.
The companies selected are mostly involved in the fields of information technology, biology, automation and new materials.
With this group of companies, the total receiving the government's blessing has risen to 51 companies.
(Source: AFX - Asia)
Nycomed Joint Venture Opens US $34 Million Shanghai Facility
Nycomed Amersham PLC recently announced that its joint venture company Shanghai Nycomed Pharmaceutical Co Ltd has opened a US $34 million pharmaceutical factory in Shanghai.
The partners in the joint venture include Nycomed Amersham, which will own 80 percent of the equity, Shanghai ZJ Hi-tech Park Development Company with 13 percent and Shanghai Huai Hai Pharmaceutical Factory with 7 percent.
Nycomed Amersham's bio-medical operations, APBiotech, will move its activities in China to Shanghai Nycomed Pharmaceutical's factory in the end of this year.
(Source: AFX European Focus)
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Shanghai Roche Increases Vitamin B6 Production
Shanghai Roche Pharmaceuticals Company Ltd. has completed its phase II project in the Pudong New District, Shanghai, making it the second biggest vitamin B6 producer in the world and the biggest in China.
The company is a joint venture between Roche and the New Asia Company with an investment of nearly US $30 million.
The completion of the phase II project enables the company to produce 1,000 tons of vitamin B6 each year, mainly used in drug and animal feed production.
The company said 60 percent of the vitamins are for overseas markets.
By the end of 1999, the investment by Roche in China totaled US $200 million, involving five joint ventures and a holding company.
The company said 77 percent of the invested capital had been used for vitamin production.
The company's sales revenue in China reached US $250 million.
(Source: Xinhua News Agency)
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The China Lex Pharma Newsletter is intended to be used for news purposes only. It should not be taken as comprehensive legal advice, and Lehman, Lee & Xu will not be held responsible for any such reliance on its contents.
