Related examination and approval in the immediate pharmaceutical auxiliary market or unprecedented integration

Not long ago, the State Food and Drug Administration issued the announcement on matters related to the review and approval of drug packaging materials and drugs (Draft for comments), requiring that the packaging materials, containers and pharmaceutical auxiliary materials directly in contact with drugs should be reviewed and approved together with the application for drug registration instead of being approved separately, and briefly describing the relevant contents of the related approval As soon as the draft for comments was published, the whole excipient market was not good, and the research and development of related preparations was once stuck in a state of stagnation and wait-and-see Everyone was anxiously waiting for the implementation of relevant policies of the state on excipient supporting DMF, so as to carry out the work What changes will be made in the registration of pharmaceutical excipients? What is the position of excipients in drug quality? What are the problems in the current market of pharmaceutical excipients in China? Today, let's talk about the medical excipients Excipients are very important to drug quality The so-called pharmaceutical excipients are an important part of pharmaceutical preparations In the pharmaceutical composition, they are not only inert ingredients, but also have many functions, such as improving the stability, bioavailability and patients' compliance of pharmaceutical preparations, improving the safety and effectiveness of pharmaceutical preparations in application, changing or controlling the release rate of drugs from preparations, so as to achieve the goal of stable drug delivery And so on The purity of pharmaceutical excipients directly affects the quality, stability and safety of pharmaceutical preparations Some excipients have unclear structure, may have physical, chemical and pharmacological incompatibility with the drug or have potential safety hazards, which will affect the stability, effectiveness and safety of the drug In addition, some impurities will have uncertain pharmacological effects in the use environment, thus bringing potential risks to the safety of the product Pharmaceutical excipients are not only the basic materials and important components of pharmaceutical preparations, but also the key to improve and improve the quality of pharmaceutical preparations Through the scientific and reasonable selection of pharmaceutical excipients, the quality and performance of pharmaceutical preparations can be effectively improved, which plays an extremely important role in pharmaceutical preparations Therefore, the development and progress of pharmaceutical excipients play an important role in the development and application of pharmaceutical preparations The current situation of pharmaceutical excipients in China is awkward and there is a great opportunity to expand Due to the weak research on the physical and chemical properties, technology and safety of pharmaceutical excipients in China, the development and application of pharmaceutical excipients are relatively limited These problems have become an important factor restricting the research and development of drugs in China First of all, there are different standards for pharmaceutical excipients The production enterprises of pharmaceutical excipients in China are involved in different industries such as medicine, food and chemical industry The standards of pharmaceutical excipients are not uniform, mainly including the following four kinds: national pharmaceutical standards, local pharmaceutical standards, national food standards and enterprise self-determined standards Due to the lack of uniform standards for various auxiliary materials, the product quality among enterprises is uneven, and even some enterprises have quite large differences in different batches of products Secondly, there are few varieties of pharmaceutical excipients, which are difficult to meet the development and application of pharmaceutical preparations At present, there are more than 500 kinds of excipients used by pharmaceutical manufacturers in China, 270 of which are included in the 2015 edition of Chinese Pharmacopoeia, while about 1500 kinds of excipients are used in the United States, accounting for about 50% of the excipients in the United States Pharmacopoeia national formulary Compared with that, the research and development of pharmaceutical excipients in China is slow and the types are scarce Thirdly, the degree of specialization of pharmaceutical excipients production is low There are more than 200 companies specializing in the development and production of pharmaceutical excipients in the world Europe and the United States are the research and development bases of pharmaceutical excipients in the world In China, there are only more than 10 companies specializing in the production of pharmaceutical excipients, most of which are food and chemical product manufacturers 80% of pharmaceutical excipients are produced by non pharmaceutical production license enterprises Compared with German BASF, American kalekang and other foreign excipients manufacturers, China lacks professional pharmaceutical excipients manufacturers, which is also a big cake for the market At present, foreign pharmaceutical excipients account for 10% ~ 20% of the output value of the whole pharmaceutical preparation Due to the late start of pharmaceutical excipients in China, the overall level is still low, so the proportion of domestic pharmaceutical excipients in the whole drug is still low, generally considered to be about 3% - 5% According to statistics, in 2013, the total industrial output value of China's chemical pharmaceutical industry was 573.093 billion yuan, the total industrial output value of Chinese patent medicine manufacturing industry was 506.498 billion yuan, and the total industrial output value of biological and biochemical products manufacturing industry was 238.136 billion yuan, totaling 1317.728 billion yuan According to the proportion of pharmaceutical excipients accounting for 4% (middle value of 3% - 5%) of the total output value of pharmaceutical preparations in China, the market scale of domestic pharmaceutical excipients in 2013 is estimated to be about 53 billion yuan There is no doubt that the market prospect of pharmaceutical excipients will be broad in the new situation What is the impact of policy changes on excipients market and pharmaceutical enterprises? 1 To cancel the "separate approval" in China, there is a separate approval way for the listing approval of new excipients (both in Europe and the United States are related to the drug listing approval) Generally speaking, the average time of registration application is 3-5 years For excipients with national standards, the approval number of medicinal excipients can be obtained through the registration license In this draft, the drug packaging materials and pharmaceutical excipients that are directly in contact with drugs will be reviewed and approved at the time of drug registration application instead of being approved separately, which means that the country will no longer accept the registration application of drug packaging materials and pharmaceutical excipients separately, while the drug declaration enterprises must strengthen the inspection of excipients and the audit of suppliers, which greatly increases their responsibilities 2 Make sure that the quality director "draft for comments" clearly takes the preparation enterprise as the first person in charge of the quality of auxiliary materials, hoping to improve the standard of auxiliary materials In addition to focusing on quality, pharmaceutical enterprises mainly depend on whether they have production approval documents when selecting auxiliary materials The main body of responsibility for the quality of auxiliary materials is usually not clear enough When the problems of excipients lead to the occurrence of group drug damage events, preparation enterprises and excipients enterprises often shirk their responsibilities to each other Clear quality responsible person, although the responsibility of pharmaceutical enterprises has greatly increased, but the efficiency of drug registration and quality standards will be greatly improved 3 Determine the "deadline" requirements of the draft for comments, and submit the domestic pharmaceutical excipients to the food and drug administration department according to the new application data requirements before January 1, 2018 According to the requirements of the new application materials, the enterprise must provide stable production technology, and many auxiliary material suppliers' factories are often in a state of scattered and small, so it is difficult to submit materials under the new standard in a short period of time Many small enterprises do not rule out the possibility of delisting as a result, and the probability of new brand shuffling in pharmaceutical auxiliary industry will be greatly increased In summary, China's pharmaceutical excipients started late with few varieties, which is difficult to compare with developed countries, but the state regulation of pharmaceutical excipients has never been relaxed The State Food and drug administration has successively promulgated a series of laws and regulations, such as the administrative measures for the registration of pharmaceutical excipients, the quality management specifications for the production of pharmaceutical excipients, and the quality standards for pharmaceutical excipients After collecting opinions from all parts of the country, we believe that a relatively complete DMF will be issued after the release of the draft At that time, the probability of integration of pharmaceutical auxiliary industry due to standardization will be greatly increased, and the drug registration work will be more efficient due to the standardization of pharmaceutical auxiliary!