Production address: No. 2, Zhongyu South Road, Xixiangtang District, Nanning City
China's pharmaceutical accessories industry is looking forward to higher quality development
May 27, 2007 - pharmaceutical excients have important functions such as shaping, acting as carrier, improving drug stability, increasing dissolution, facilitating dissolution, and controlling release, which may affect the quality, safety and effectiveness of preparations. Under the background that the current policy encourages the development of high-end preparations and API advocates green development, it is imperative to promote the development of high quality pharmaceutical excipients in China. According to the functions and USES, medicinal excipients can be divided into four categories. The auxiliary materials for injection are antioxidants, solvent AIDS and isotonic regulators, etc. The excipients of oral solid preparations are lubricants, fillers, adhesives and diluents, etc. The excipients of oral liquid preparations are dispersants, stabilizers and suspension AIDS, etc. Excipients for external use are anti - adhesive, flavor - correcting agent, ejector and so on.
May 27, 2007 - pharmaceutical excients have important functions such as shaping, acting as carrier, improving drug stability, increasing dissolution, facilitating dissolution, and controlling release, which may affect the quality, safety and effectiveness of preparations. Under the background that the current policy encourages the development of high-end preparations and API advocates green development, it is imperative to promote the development of high quality pharmaceutical excipients in China.
The key fundamental role has become increasingly prominent
Medicinal excipients can be divided into four categories according to their functions and USES. The auxiliary materials for injection are antioxidants, solvent AIDS and isotonic regulators, etc. The excipients of oral solid preparations are lubricants, fillers, adhesives and diluents, etc. The excipients of oral liquid preparations are dispersants, stabilizers and suspension AIDS, etc. Excipients for external use are anti - adhesive, flavor - correcting agent, ejector and so on.
China is accustomed to the concept of "heavy API and light excipient" in the development of pharmaceutical preparations. When the API industry is developed on a large scale, the importance of pharmaceutical excipient industry is not enough. China's pharmaceutical excipients industry also started relatively late, accounting for 3% ~ 5% of the total output value of pharmaceutical preparations. In 2017, China's pharmaceutical excipients market size was about 119.3 billion yuan. In the world, medical excihients usually account for 10% ~ 20% of the output value of the entire pharmaceutical preparation. By 2023, the global market size of medical excihients is expected to reach $85.3 billion. China's pharmaceutical accessories market has a broad development space.
At present, under the background of encouraging drug innovation and development, pharmaceutical preparations are efficient, quick, effective and the direction of small doses and side effects of small, oral quick release, release and other oral interpretation of the drug delivery system, liposome, lipid microsphere and nanoparticle preparation new injection drug delivery system, through the skin and mucosal drug delivery systems, special populations such as children used dosage forms, such as new high-end preparation technology become a development trend of the development and production of new pharmaceutical excipients in high-end pharmaceutical preparations plays a decisive role.
The development of generic drug quality and efficacy consistency evaluation also promotes the transformation and upgrading of pharmaceutical excipients industry. The generic drug consistency evaluation requires that the quality and efficacy of the generic drug should be consistent with that of the original research drug. Pharmaceutical excipients are important factors to ensure the selective delivery of the drug to specific tissue sites in a certain process, control the release rate of the drug, and directly affect the in vitro dissolution curve and in vivo bioequivalence. The promotion of generic drug consistency evaluation urges pharmaceutical manufacturers to improve the quality requirements of pharmaceutical excipients from the pursuit of low cost to the pursuit of high quality and stability. When selecting excipients, enterprises pay more attention to whether the production of excipients is standard, whether the quality is stable, and whether all the indicators are up to the standard. Therefore, the supplementary materials used in reference preparations become the first choice of generic pharmaceutical enterprises. With the increase of the sales volume of the varieties evaluated by consistency and the increase of the number of drugs evaluated by consistency, the transformation and upgrading of domestic pharmaceutical excipients industry from low-end bulk excipients to refined high-end excipients will be accelerated.
At the same time, the state's attention to the pharmaceutical accessories industry is gradually increasing. In 2012, the development plan of biological industry issued by the state council clarified the key and basic role of medicinal excipients in the field of drug development. In 2016, the ministry of industry and information technology issued the development planning guidelines for the pharmaceutical industry, which stressed the need to support the development and application of new medical excipients. Meanwhile, the regulatory system of pharmaceutical excipients industry is becoming more and more standardized. The 2015 edition of the Chinese pharmacopoeia has for the first time compiled the general rules and medicinal excipients separately, and added the guiding principles for the research of functional indexes of medicinal excipients to boost the development of the standard of the pharmaceutical excipients industry. Introduced in 2016, the state drug regulatory department of medicine packaging materials pharmaceutical excipients associated with drug review announcement of relevant matters of examination and approval, the pharmaceutical excipients from separate examination and approval to the examination and approval when applying for drug registration for examination and approval of the review, along with all the marking the pharmaceutical excipients management approval from age into the era of document management, and international pharmaceutical excipients management system.
Development faces four major challenges
China has a vast space for the development of medicinal excipients, but it still faces four major challenges.
First, the international standard system to be optimized. Chinese pharmacopoeia is a legal technical standard to be followed in the research, development and production of pharmaceutical excipients in China, and an important technical standard for the standardization and standardization development of the pharmaceutical excipients industry in China. At present, there are more than 540 kinds of medicinal auxiliary materials in use in China. The standard of auxiliary materials in the Chinese pharmacopoeia has increased from 132 kinds in 2010 to 270 kinds in 2015. The number of medicinal excipients used in the United States and Europe is about 1500 and 3000, respectively, and the standard of medicinal excipients included in pharmacopoeia is about 750 and 1500, respectively, which are much higher than that in China. In addition, many new medicinal excipients have been widely used abroad, but have not been produced in China. Therefore, in the variety number and specifications, there is a lot of space to expand the standard of medicinal accessories in China.
Second, the implementation of import substitution needs multiple layout. China's bulk medicinal excipients can basically meet the domestic demand, but there is a gap between the quality standards and foreign countries. Complex and new medical excipients have strong import dependence. At present, there are 144 kinds of foreign medical auxiliary materials registered in China, and the most registered varieties are microcrystalline cellulose and lactose. The largest production places of imported medical auxiliary materials in China are Germany and the United States, followed by Japan. The development of high-end preparations and the supply of pharmaceutical accessories have become a pain point for pharmaceutical enterprises in China. In recent years, our country began to layout the production of new medicinal excipients, new tianjin new drug excipients base, zhuhai gel industrialization base and so on. But in general, new varieties are still few, specifications and dosage forms are far from meeting the requirements of the development and production of new dosage forms and improving the quality of pharmaceutical preparations. Therefore, the layout of the research and development of new auxiliary materials, become the key to promote the development of domestic pharmaceutical auxiliary industry.
Third, the technical threshold and research and development investment to breakthrough. The production of new medicinal excipients requires high technical requirements. The production of medicinal auxiliary materials is a refining process from chemical raw materials to fine auxiliary materials. Many domestic chemical enterprises are not mature in the production of medicinal auxiliary materials, and the research and development investment of enterprises specializing in the production of medicinal auxiliary materials is insufficient, and the quality management is backward. The quality inspection of many macromolecular medicinal excipients is only limited to the simple identification of physical and chemical properties, and lack of identification and detection of functional indicators. Complex and new medical excipients are mostly produced by large international chemical enterprises with mature production technologies, and the main suppliers include dow dupont, basf, vac, ashland, arkema, evtron and so on. China has a long way to go to make technological breakthroughs in pharmaceutical accessories.
Fourth, the upstream and downstream industrial chain closed loop to open. At present, China's pharmaceutical excipients industry presents "polarization". Due to the limitation of capital and technology, most domestic pharmaceutical auxiliary products are in the low-end market with simple technology, low technical requirements and fierce product competition. The supply of new and complex products with complex technology, high technical requirements and high quality requirements is insufficient. There are about 470 pharmaceutical accessories manufacturers in China, most of which are distributed in bohai rim region, Yangtze river delta region and pearl river delta region. Shandong, jiangsu, guangdong and hebei are provinces where pharmaceutical accessories manufacturers gather. Enterprises specializing in the production of auxiliary materials are generally transformed from food additive enterprises and chemical enterprises, with small scale, single products and poor standardization. At present, China's large-scale pharmaceutical accessories manufacturers include hunan erkang pharmaceutical, shanhe pharmaceutical auxiliary, huangshan capsule, hongri pharmaceutical, etc., but the market share of these four enterprises in the pharmaceutical accessories industry is less than 5%. On the whole, the upstream and downstream industrial chain of pharmaceutical excipients in China is poorly connected, and the industrial chain of chemical enterprises - excipients enterprises - pharmaceutical enterprises or chemical enterprises - pharmaceutical enterprises has not been formed yet.
The future direction is clear
The author believes that with the development and innovation of preparations and the continuous improvement of quality requirements, new medical excipients will be the key development direction of China's medical excipients in the future. The details include: development of new auxiliary materials, secondary development of existing auxiliary materials, development of premixed auxiliary materials, etc. Among them, the research and development cycle of new accessories and new specifications of accessories is long, with high risk, large investment and low rate of return; Premixed excipients are a variety of single excipients that are pre-mixed uniformly in accordance with a certain formula proportion and a certain production process, and are used as an excipient in the preparation as a whole, with specific formula composition, collection of multiple functions, time and cost saving features. Therefore, the development of premixed excipients is the preferred path for the development and application of new medicinal excipients.
With the gradual improvement of the system system and standard system, the degree of specialization and scale of the industry is gradually improved. In the future, China's pharmaceutical accessories industry will gradually enter a mature stage. In terms of quantity, there is a large space for the use of varieties and specifications of medicinal accessories in China. In terms of quality, the promotion of generic drug quality and efficacy consistency evaluation will lead to the increase of import of medicinal auxiliary materials and the standardization of domestic pharmaceutical auxiliary materials market, accelerating the transformation and upgrading of the industry. At the same time, under the innovation drive of new preparation development, it is imperative to accelerate the domestic pharmaceutical excipients industry to be in line with the international standards.