1. Guidance policy for foreign investment in medicine industry
In order to adapt to the economic development and new situations after China¡¯s entry into WTO, Chinese Government revised the Catalogue for the Guidance to Foreign Investment Industries in 2002, and actively encouraged foreign merchants to make investment in medicine industry of China.
1)In accordance with the revised Catalogue for the Guidance to Foreign Investment Industries, the items encouraged in medicine industry include:
Planting and breeding of TCM materials (limited to joint venture and cooperative venture)
Manufacture of the APIs with the patent in China or under the administrative protection, or the chemical APIs necessarily imported
Vitamin: manufacture of nicotinic acid
Amino acid: manufacture of serine, tryptophan, histidine etc.
Manufacture of analgesic using new technique and equipment
Manufacture of new-type anti-neoplasm drugs and new-type drugs used to treat cardio-cerebrovascular disease
Manufacture of new-type, high-efficient and economic contraceptives
Manufacture of new-type medicine using biotechnology
Manufacture of gene engineered vaccine (AIDS vaccine, hepatitis B vaccine, and contraception vaccine)
Development and manufacture of marine medicine
Manufacture of diagnosis reagents for AIDS and radio immunity
Medical preparation: manufacture of new-type preparations and products, using new technology, such as slow release, control release, targeting and percutaneous absorption etc.
Development and application of new-type medicinal adjuvant
Processing and manufacture of TCM materials, TCM extracts, prepared Chinese medicine (exclude the traditional processing technique of TCM decoction pieces)
Manufacture of biomedical materials and products
Manufacture of animal antibacterial APIs (including antibiotics and chemical synthesized medicine)
Development and manufacture of new products and new types of formulation, such as antibacterial drugs for animal use, repellent, insecticide and pesticide.
2) The forbidden items include: Processing of TCM materials, listed as the national protective resources (musk, licorice and jute etc.)
Application of traditional processing technique for TCM decoction pieces and manufacture of the prepared Chinese medicine applying secret recipe. As for the foreign invested medicine projects, it is required that Chinese side shall take the controlling position in the manufacture of addictive stupefacient and psychotropic drugs APIs; but the other items have no such requirement.
2. National regulation policies for medicine industry
The National Development & Reform Commission of China formulated the Catalogue of Items in Low-level Redundant Development in Some Industries together with the departments concerned on April 30, 2004, among which items in 10 industries including medicine industry were listed as forbidden and restricted ones. According to the regulation, the financial institutions shall terminate any new credit extension support to the listed forbidden and restricted items.
Medicine industry has 9 forbidden items and 7 restricted items.¡¡
1) Forbidden items
Manual capsule filling
Medicine packing technique by cork wax seal
Tower-typed heavy distilling apparatus
Hot-air drying oven without purification facilities
Ampoule wire-drawing encapsulation machine
Lead-tin ointment tube
Ampoule used for packing of powder and injection
Natural plastic plug for medical use
Item of Straight-neck ampoule
2) Restricted Items
Item of vitamin C raw material
Item of penicillin APIs
APIs items, which fail to reach the national standard in the aspects of labor protection and three-waste treatment
Item of disposable injector, blood transfusion device and transfusion sets
Item of butyl plastic plug for medical use
Item of formulation processing capacity expansion without the application of new medicine and technology (exclude hard capsule filled with liquid)
Item of production capacity expansion on the products made of endangered species of animal or plant or those in short supply, and cannot be planted or raised in large scale
3. National supervision policy for medicine market
In 2004, the Government has promulgated a series of medicine policies, which have some great influence on pharmaceutical enterprises and medicine commercial enterprises. The policy that China reduces the tax-refund rate for the export of medicinal products has become effective since January 1, 2004.In 2004, the National Development & Reform Commission has distributed the Notice on Reducing the Price of 24 Varieties of Antiinfective Drugs and Notice on the Issues Concerning Further Strengthening the Supervision on Medicine Price and Alleviating the Burden of Medical Fee ion the Society, which specifies the maximum detail prices on antibiotics in more than 400 specifications, and reduces the prices of some drugs. State Food and Drug Administration requires that the manufacturers of medical preparation and APIs, which have no GMP certificate accordant to its formulation or varieties, shall suspend the production as of July 1, 2004.From December 31, 2003, medicine operation must comply with the Good Supplying Practice for Pharmaceutical Products and obtain GSP certificate. Compulsory implementation of GMP and GSP has not only impelled the medical enterprise to improve the software and hardware standard of production operations, but also intangibly raised the threshold to medical industry. |
