Consistency evaluation to promote the overall competitiveness of pharmaceutical industry to be improved

[market analysis of chinapharma.com] a few days ago, Qingdao Baiyang pharmaceutical's metformin new drug Nida, which uses osmotic pump controlled release technology, was approved and listed by the FDA in the United States, bringing good news for patients with type 2 diabetes Nida is consistent with the original drug in terms of active ingredients, route of administration, dosage form, use conditions and bioequivalence It is expected that Nida will be approved for market in China within this year and is expected to become the first metformin product of osmotic pump controlled release dosage form in China In addition, the industry estimates that the price of the domestic listing of the product may be only 1% of the price of the original research drug in the U.S market The product is approved to be listed in the United States, which means that China's generic pharmaceutical technology has made another major breakthrough Some insiders believe that with the development of generic consistency evaluation, the generic industry is ushering in policy dividend In this context, in order to improve the market competitiveness, pharmaceutical enterprises that engaged in the research and development and production of generic drugs earlier will continue to improve their research and development capabilities, process capabilities and quality management capabilities In the next few years, China's pharmaceutical technology may present a major outbreak For example, in order to improve the preparation level, increase the quality control ability and meet the market demand in the future, some preparation enterprises have built a relatively large and comprehensive preparation building Based on the construction of new infrastructure, the company has introduced good equipment at home and abroad at present, and at the same time introduced domestic injection talents The pharmaceutical company said that after the new preparation building is put into use, the company's preparation capacity, quality assurance capacity and product capacity will be further improved However, the industry also said that after the introduction of a series of measures, such as generic drug consistency evaluation, drug listing license holder system, drug registration reform, and "two vote system", the consistency evaluation cost is high, the cycle is long and the requirements for research and development capacity are high, which greatly increased the operating cost of pharmaceutical enterprises At the same time, with the implementation of volume procurement, the market pattern of generic drugs has changed, and pharmaceutical companies have to reduce costs, while pharmaceutical companies without API industry chain are difficult to win in the fierce market competition In this context, some pharmaceutical companies extend their production capacity to the downstream based on characteristic APIs, which can basically meet the needs of the extension of the existing variety industry chain The company said that if it wants to expand the production capacity of preparations, it needs to purchase approval documents to expand the variety and scale of preparations, and the implementation of conformity evaluation of generic drugs has reduced the channels and made the price expensive In addition, even if the purchase is approved effectively, if a good and stable API supplier cannot be found, it is difficult to win in the fierce market competition Compared with the fierce domestic competition, in the aspect of the export of preparations, China's export performance of preparations has improved in recent years, and the export volume has increased significantly According to the data, in 2017, China's pharmaceutical exports reached US $3.456 billion, an increase of 8.32% year on year In addition, the 13th five year plan guide for the development of pharmaceutical industry puts forward the implementation of the strategic development goal of pharmaceutical internationalization, comprehensively improving the scale, proportion and added value of China's pharmaceutical exports, and focusing on expanding the markets of developed countries and emerging pharmaceutical markets In general, although the internationalization of preparations in China has made a great breakthrough, the overall level is still weak The industry pointed out that the pharmaceutical industry is facing challenges such as weak overall competitiveness, weak international thinking and concept, overcapacity and low-level repeated construction leading to excessive competition of homogeneity, serious imbalance of input and output, and the profitability of China's drug export still needs to be improved.