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It is understood that although China's exports of chemical raw materials are relatively large, there are not many products registered and certified through the international market. At the end of 2004, China achieved only 60 and 192 products with European and US registered certification, accounting for 3.6% and 4.3% of the global total. Most products still enter the international market in the form of chemical products, such as China's large exports to India. The penicillin industrial salt, after further deep processing in India, entered the country market as a drug.
At present, Chinese pharmaceutical companies generally lack internationally certified products and experience in the operation of the international market. Most of China's chemical raw material pharmaceutical products have not obtained permits to enter the international market. In terms of drug production process management and quality assurance system, there is still a certain gap between China and international developed countries. There are very few manufacturers and products that have passed international certification. Domestic pharmaceutical companies generally lack professionals with experience in the operation of the international pharmaceutical market, and their internationalization capabilities are weak.
The “Eleventh Five-Year Development Guidance Opinions for the Pharmaceutical Industry†proposes that in order to improve the international competitiveness of China's pharmaceutical industry, China will refer to international standards in the next five years, learn from the development experience of international natural plant drugs, and follow the drug registration requirements of relevant countries. Develop natural medicines in China, realize drug registration in developed countries, and enter the international pharmaceutical market.
China will accelerate the development of innovative drugs and specialty generic drugs, and continue to consolidate and enhance the advantages of traditional chemical raw materials and generic drugs, vigorously develop and develop specialty APIs and innovative drugs, strive to open up the international market for pharmaceutical preparations, and improve exports. Product structure, increase the added value of pharmaceutical products.
In terms of specific product development goals, the chemical raw material field will realize the industrialization of 20 products with high potential for market growth and high added value; the field of chemical pharmaceutical preparations will strive to obtain the listing qualification of 5 pharmaceutical products in the United States or EU countries. It has truly entered the international mainstream pharmaceutical market; in the field of traditional Chinese medicine products, it develops and markets 20 to 30 quality traditional Chinese medicine products with perfect quality standards, a clear mechanism of efficacy, and safety, efficiency, stability, and controllability.
In order to improve the quality management level of pharmaceutical companies, China will also actively promote product certification for entering the European and American markets on the basis of domestic GMP certification to meet the needs of the domestic market for higher-level pharmaceutical products; at the same time, it will develop internationally with high quality and reasonable prices. The raw material medicine market will increase the added value of products and the grade of export products.
During the “11th Five-Year Plan†period, China will also set up special items for the export of pharmaceutical preparations, encourage the export of products with independent intellectual property rights, exact curative effects, and large international market demand, and increase the international competitiveness of pharmaceutical products.
In the Eleventh Five-Year Plan, China's Pharmaceutical Industry Should Play a "World Card"
According to the “Eleventh Five-Year Development Guidance Opinions for the Pharmaceutical Industry†recently released by the National Development and Reform Commission, during the “Eleventh Five-Year Plan†period, the pharmaceutical industry must focus on establishing a pharmaceutical industry with strong international competitiveness, and some fields should enter the world. Leading the ranks, lay a solid foundation for the transition to a powerful pharmaceutical country.