At the 12th World Pharmaceutical Raw Materials China Exhibition held on April 19, a press conference revealed that currently developed countries such as Europe and the United States are increasingly strict on the supervision of imported chemical raw material medicines, and they are continuously improving the access threshold for chemical raw materials and drugs. Experts said that there are many export-oriented chemical raw material companies in China, of which private enterprises account for 76%, and increasingly strict international supervision will further force China's chemical raw material medicine industry to accelerate its reshuffle.
According to Cui Bin, secretary-general of the China Chamber of Commerce for the Import and Export of Medicines and Health Products, in 2011, China's chemical raw material and pharmaceutical enterprises maintained a strong growth momentum, and the annual output value was 308.19 billion yuan. However, the low scientific and technological content and excess production capacity still plague the development of chemical raw materials in China. Cao Gang, director of the western medicine department of the Chinese Medicine and Health Products Import and Export Chamber of Commerce, said that in 2011, 47% of chemical API varieties had an average export price below US$10/kg, and nearly 31% of chemical API varieties had an average export price of US$5/kg. Below, excess capacity is the main reason.
One side is the overcapacity of chemical raw materials, while the other is the international supervision of chemical raw material drugs. Cao Gang said that governments in various countries are improving the market entry threshold for chemical raw material medicines, and the preparation procedures for China's chemical raw material medicines that “go global†are increasingly complicated, and the production conditions and quality standards to be met are increasingly numerous. The new Decree No. 2011/62/EU promulgated by the EU Parliament and the European Commission requires that from July 2nd, 2013, all active persons in Europe must issue written declarations from the regulatory authorities of the exporting country. Recently, the U.S. Food and Drug Administration issued an import warning to 22 Chinese chemical raw material companies on the ground that the production regulatory system may not meet the requirements of the current pharmaceutical production management regulations.
Cui Bin said that the competitive pattern of export of chemical raw materials in China is relatively decentralized, and the increase in export threshold has a greater impact on a large number of SMEs. In 2011, there were 9,428 enterprises that exported chemical raw materials in China. There were 7,194 companies that exported less than US$1 million, accounting for 76.3% of the total number of exporters of chemical APIs. Among all export enterprises, the number of private enterprises was The proportion of up to 76%.
Cui Bin stressed that the reshuffle of chemical raw materials companies is conducive to promoting the transformation and upgrading of the industry. The high-end certifications of developed countries in Europe and the United States will limit the access of a group of small enterprises and will facilitate the merger and reorganization of chemical raw material companies. He suggested that the government further encourage the transformation of pharmaceutical companies, such as giving stronger incentives to companies that pass high-end certification in Europe and the United States.
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