Multiple objective factors affect the development of pharmac

With the continuous development of the pharmaceutical industry, the application of pharmaceutical excipients in the industry is also gradually widespread. However, at present, some domestic pharmaceutical excipients are still produced and provided by chemical enterprises. There are only dozens of real pharmaceutical excipients enterprises, so the efficiency and concentration of the pharmaceutical excipients industry need to be improved. The implementation of the new version of GMP will make the survival pressure of many small chemical enterprises increase continuously, and the pressure of the pharmaceutical accessories industry will increase accordingly. At present, what problems still exist in China's pharmaceutical excipients industry? From the perspective of enterprises themselves and policies, relevant experts have given their views and suggestions on the development and trend of pharmaceutical excipients industry in 2014.

On the one hand, the R&D and application level of pharmaceutical excipients in China is low, and the stability and application performance of imported excipients are better than those of domestic products. For example, microcrystalline cellulose, imported varieties will clarify functional indicators, but domestic varieties often lack such indicators, which leads pharmaceutical companies to prefer to purchase imported accessories.

The survey results show that 80% of foreign brand drugs and domestic brand generic drugs consumed by third-class hospitals in large and medium-sized cities are imported excipients. In the past two years, the average annual growth rate of sales of imported accessories is about 20%, which is obviously better than that of domestic accessories.

On the other hand, the registration and management of pharmaceutical excipients in China takes a long period of approval, especially the registration and declaration of imported excipients and new excipients takes an average of 3-4 years. The high time cost hinders the introduction and application of new excipients and imported excipients.

The key to the development of China's pharmaceutical excipients industry is to further reform and opening up, and the registration and management system of pharmaceutical excipients should be reformed. In the development of pharmaceutical excipients, drug standards are not uniform and approval numbers are not uniform. The original drug standards in China are divided into two levels, namely national and local standards. The two levels of approval are also implemented, and the approval numbers are "National Pharmaceutical Standard" and "Local Approval Number".

Therefore, the standards of excipients used by pharmaceutical manufacturers are not uniform. There are drug standards, food standards, chemical products standards, cosmetics standards and other standards. Some excipients, such as pigments, flavor modifiers, cosolvents and so on, including some cold-door excipients used in very few drugs, have similar problems. Therefore, it is difficult for manufacturers to produce drugs according to strict drug standards. The existence of these objective factors affects the development of the pharmaceutical excipient industry.