New opportunities for the development of pharmaceutical enterprises

[editor's point of view of chinapharma.com] the preparation plays a connecting role in the pharmaceutical industry chain It can not only support the research and development of new drugs, but also help the industrialization of new drugs Pharmaceutical research and development technology has an important impact on the effectiveness and safety of generic drugs With the promotion of the policy of generic drug consistency, China's generic pharmaceutical enterprises continue to keep consistent with foreign pharmaceutical enterprises in pharmaceutical technology, which is expected to drive the development of pharmaceutical machinery The long-term development mode of "heavy API, light preparation" in China's pharmaceutical industry has led to the strong position of API, but the pharmaceutical industry is very weak, which directly leads to the abnormal development of China's pharmaceutical industry The following pharmaceutical machinery in the pharmaceutical industry is also ignored, has been a weak link in pharmaceutical machinery In recent years, with the development of pharmaceutical products, China's pharmaceutical industrial structure has been further improved Recently, the reporter learned from the press conference on pharmaceutical trade and investment situation hosted by China Medical Insurance chamber of commerce that last year, the import and export volume of China's pharmaceutical and health care products exceeded 100 billion US dollars, reaching 102.6 billion US dollars, an increase of 4.73% year-on-year, of which the export of raw materials decreased by 0.9% year-on-year, and the export of preparations increased by 8.8% year-on-year Industry insiders pointed out that with the adjustment of industrial structure and the gradual improvement of national support policies, many traditional pharmaceutical enterprises have adjusted the industrial structure, and strive to improve the market competitiveness of pharmaceutical products, so the reform of pharmaceutical machinery is imperative Many hospital preparation rooms have difficulty in examination and approval due to the change of the hospital preparation management system, the R & D process of new preparations is complex, the cost climbing time cycle is longer, the production scale is shrinking day by day, and the R & D enthusiasm of hospitals is also getting lower and lower Due to policy restrictions, the hospital preparations can not be directly sold on the market If we want to go out of the hospital, we must carry out industrial production, but the way to the market is also difficult because of management mechanism, lack of enthusiasm of pharmaceutical enterprises and other problems In recent years, some county-level hospitals directly cancel the preparation room The pharmaceutical enterprises have professional production process, integrated production process, and large-scale operation, which greatly reduces the cost of expenditure, and can achieve a good price advantage in the market competition With the withdrawal of preparations in the hospital, preparation enterprises gradually gain new vitality because of their professional production process and price advantages, and begin to flow into the market With the rapid development of pharmaceutical industry in China and the improvement of the legal system of the supervision and registration of pharmaceutical preparations in medical institutions, pharmaceutical enterprises have expanded their share of preparations Some large pharmaceutical enterprises, through merger and asset reorganization, vigorously develop preparation machinery, accelerate the pace of innovation, strictly implement GMP requirements, and implement large-scale operation They have strong advantages in production conditions, quality control and price, and the preparations produced can also meet clinical needs It is an opportunity as well as a challenge for pharmaceutical enterprises to strictly implement the policy of steady development of standard process and the good market for pharmaceutical machinery The opportunity is easy for many enterprises to be eager for success when they are in production In order to reduce the cost too much for profit, there are defects in quality As we all know, the safety, effectiveness and convenience of drugs are not only related to the active ingredients of drugs, but also closely related to the way of administration, dosage form and technology So in order to grasp the market, we must start from the quality of machinery Of course, not all pharmaceutical companies can produce high-quality preparations With the threshold of innovative preparations rising, only a dozen of ordinary innovative preparations, such as sustained-release tablets, can be approved in hundreds of enterprises Technical barriers should be formed for innovative preparations, which is a kind of technology difficult to control If the same preparation is produced with different process equipment, the clinical effect may be greatly different Many foreign pharmaceutical companies have been able to test the preparation production process from the performance level indicators, such as fluidity, density, excipient crystal form, etc However, when the level of preparation is not up to that of foreign countries, China's preparation machinery should strictly follow the concept of a system engineering to prepare and analyze each kind of preparation, comprehensively use modern biomedical technology, including physical, chemical, engineering and precision manufacturing and processing technology, and comprehensively study the theory, production process and preparation design of drug formulations and preparations Finally, the evaluation method is to obtain stable, high efficacy, low toxicity, easy to use, and adapt to and meet the needs of various clinical treatment of pharmaceutical preparations system engineering Only when the mechanical process quality is well done can we be qualified to say innovation and compete with foreign enterprises for the market.