Encouraging R&D of Pharmaceutical Industry

At present, the research and development cost of pharmaceutical excipients in China is relatively high, the registration link needs to be improved urgently, the R&D input and output of enterprises are relatively low, and the enthusiasm of R&D is lacking. It is imperative to learn from the experience of foreign developed countries in the management of pharmaceutical excipients and accelerate the reform of relevant management systems.

First of all, from the production level, the pharmaceutical accessories manufacturing enterprises in China are at a relatively basic level. At present, most of them stay in the stage of high energy consumption and low profit, and there is little energy and funds to invest in the development and technology research of new varieties. Secondly, from the point of view of production environment, the production of pharmaceutical excipients at this stage has no advantages in policy compared with the production of non-pharmaceutical excipients. The research and development of new excipients need to examine their safety and toxicity, and go through a long process of approval, product promotion and market growth after approval. After the high cost of registered pharmaceutical excipients, they are inevitably at a disadvantage in price competitiveness. Without relevant supporting policies, it is easy to discourage the enthusiasm of enterprises to develop new pharmaceutical excipients.

 

In fact, in the registration process, we can learn from the DMF filing management model of the United States. This registration system makes the registration efficiency of pharmaceutical excipients very high. The registration cycle is only 2-3 weeks. The Food and Drug Administration of the United States (FDA) has a series of detailed regulations on the use of excipients. For example, excipients with quality standards in the U.S. Pharmacopoeia do not need to provide quality information when new drugs are declared; if excipients or new excipients are not included in the U.S. Pharmacopoeia, the safety of application quantity must be provided. Sexual data; For some excipients that have been used but not yet included in the U.S. Pharmacopoeia, other quality standards can also be applied for. For new accessories, manufacturers must refer to the "Guidelines for Safety Assessment of Accessories" to provide safety information. For applications for excipient imitations, all ingredients must be listed in the FDA database of inactive substances or excipients. Since there is no need for clinical research in the production of generic drugs, the use of each excipient must be lower than that previously used, otherwise safety information must be provided. At the same time, FDA has also established a drug reference file, in which pharmaceutical accessories manufacturers keep confidential information of their products for FDA to access, which not only achieves the purpose of confidentiality, but also facilitates the need for FDA review.

The approval number of excipients issued by China's drug regulatory authorities is responsible for determining whether excipients can be used in the production of preparations, which to a certain extent limits the choice of excipients used by pharmaceutical enterprises, resulting in the lack of initiative of pharmaceutical manufacturers to use new excipients to develop new preparations; at the same time, domestic excipient manufacturers lack the initiative to use new excipients to develop new preparations. It also lacks the initiative to develop new excipients because of the lack of competition. Therefore, the state should give more choices to pharmaceutical manufacturers, promote enterprises to actively select a wide range of pharmaceutical excipients, explore new pharmaceutical excipients in new pharmaceutical preparations, and improve the development level of pharmaceutical preparations in China. Of course, in order to ensure the quality of pharmaceutical products in pharmaceutical production enterprises, while promoting the use of excipients enterprises to actively choose new excipients, drug regulatory authorities need to further strengthen the responsibility consciousness of pharmaceutical production enterprises, in line with the principle of who is responsible for the use of excipients, and then accountability of excipient production enterprises and business enterprises. This can not only supervise the production of pharmaceutical products, but also control the quality of accessories products.

 

In terms of administrative management system, the relevant departments of the state should refer to and learn from the DMF management model of the United States. On the basis of summing up the experience and shortcomings of excipient management in China, a medical excipient record system suitable for supervision and implementation in China should be established. This can not only shorten the registration cycle, improve the efficiency of approval and save the cost of approval, but also combine the evaluation of excipients with the approval of drugs, so as to effectively grasp the use information of drug production and marketing, and ensure the traceability of supervision and inspection.

 

New excipients in our country can be generally divided into: pharmaceutical excipients created in our country or reported only in foreign countries (pharmacological research, acute toxicity test, long-term toxicity test, mutagenicity test, reproductive toxicity test, carcinogenicity test, etc.) and existing chemicals are used as excipients for the first time in preparations (drug must be submitted). Physical research, acute toxicity test data, other information can not be required. Foreign countries have approved and applied to pharmaceutical excipients of preparations, as well as existing food additives for the first time as excipients in preparations. At present, the management of new excipients in our country is based on the corresponding declaration data according to different categories, but there is no further classification of specific drug delivery routes. The US FDA further classifies excipients according to the route of administration. If the final drug formulation used by the excipient is administered by injection, safety test data such as no acute injection toxicity of the excipient should be provided; if the final drug formulation used by the excipient is administered by skin or mucosa, it should be supplemented. Fill in the safety data such as the evaluation of the use site. Through this classification management, the safety of excipients application can be more guaranteed. FDA will provide additional data for excipients of different drug delivery routes according to the differences of short-term use, short-term or medium-term repeated use, medium-term and long-term repeated use. This not only saves a lot of manpower and material resources, but also fully guarantees the safety of public medication.