On April 9th, the medical network began to reform from the registration of chemical drugs in 2015, and the registration reform of Chinese medicine was late. When the General Office of the General Administration of the People’s Republic of China publicly solicited the “Administrative Measures on Drug Registration (Revised)” in 2017 See the change plan for the classification of Chinese medicines and natural medicines.
This article aims to review the current changes in Chinese medicine registration, priority review and regulations to seek future development opportunities for Chinese medicines and natural medicines.
Twelve batches of self-examination: Chinese medicine is in line with the overall situation
The situation of entering the self-checking batch from Chinese medicine can reflect the current status of the registration of Chinese medicine. Among the 12 batches of self-inspection batches, the Chinese medicine acceptance number accounted for 12%. After the eighth self-inspection in August 2017, there was no Chinese medicine entry acceptance number. The withdrawal rate of Chinese medicines and the disapproval rate of announcements were basically the same as the overall situation.
A total of 15 products (15 acceptance numbers) of 265 Chinese medicine acceptance numbers entered the on-site verification plan announcement of drug clinical trial data, but only three products were approved for listing, namely: Chengdu Shengkang Pharmaceutical Co., Ltd. Jiuwei Huanglian Jiedu Ointment (registered as Kezhen Toxic Ointment, National Medicine Zhunzi Z20160002), Jinhua Qinggan Granules (Zhongguo Zhunzi Z20160001) of Juxuanchang (Beijing) Pharmaceutical Co., Ltd. The Danlong Oral Liquid of Zhejiang Kant Pharmaceutical (Zhongguo Zhunzi Z20170001). The products currently approved are still the products of the first batch of clinical self-inspection and verification, and are the products before the on-site verification plan (No. 6) of the drug clinical trial data.
The products that have been withdrawn after the announcement of the on-site verification plan for the drug clinical trial data are: the Huatong natural remedy of Chengdu Huaxi natural medicine and the anti-tuberculosis capsule of Changchun Yingping Pharmaceutical.
Since the approval of Ginkgo biloba lactone glucamine injection in Jiangsu Kangyuan Pharmaceutical Co., Ltd. in 2012, there has been no product listing for Chinese medicine injection. After reviewing the sea cucumber glycosaminoglycans for injection, the Harbin Taxus Biopharmaceutical, Shanghai Kairun Biomedicine and Heilongjiang Taxus Pharmaceuticals were not approved.
ance numbers for the priority review of traditional Chinese medicines. This shows that Chinese medicine research and development projects are scarce, and projects that can meet the national priority evaluation criteria are scarcer. As shown in Table 3, the products that entered the priority review were in the clinical stage, and there was no production stage product at present, and the granules and oral liquids were the main ones. The reason for being selected for priority review was also based on children's medication.
After the clinical self-examination and verification, the approval number of the new drug for Chinese medicine has dropped to single digits for two consecutive years, and only five have been approved for priority review, which reflects the dilemma of the current research and development of Chinese medicine.
Chinese medicine related policies: Chinese medicine injections are the most concerned
At present, the most important research and development policies in the Chinese medicine industry are: re-evaluation of traditional Chinese medicine injections, classic Chinese medicine prescriptions, Chinese medicine priority review and approval, Chinese medicine new medicine clinical research technical guidelines and Chinese medicine toxic medicine quality control requirements. The most important clinical application policies in the Chinese medicine industry are the restrictions on the use of Chinese medicines, such as adjuvant medications, key monitoring drugs, clinical pathways and medical insurance payments.
Traditional Chinese medicine injections have been occupying more than 50% of the terminal market of Chinese medicine hospitals, and retail terminals account for about 30%. According to Xianda Data V3.5, there are 973 approvals for traditional Chinese medicine injections, corresponding to the common names of 135 products; the top 20 of the number of Chinese medicine injections are injections.
Re-evaluation of traditional Chinese medicine injections requires attention to adverse drug reactions such as rash, itching, chest tightness, nausea, palpitations, chills, allergic reactions, dizziness, vomiting, and difficulty breathing. Among the products related to the "Drug Adverse Drug Reaction Information Bulletin", the revised manual and the "National Report on the Monitoring of Adverse Drug Reactions" issued by CFDA in recent years, the top 20 of the batches of Chinese medicine injections are mainly Xiangdan Injection and Yuxingcao Injection. 14 products including Xuesaitong Injection, Honghua Injection, Shenmai Injection, Astragalus Injection, Shengmai Injection, Breviscapine Injection and Qingkailing Injection (Table 4). This means that 486 approval numbers out of 730 approval numbers for 20 Chinese medicine injections need to be improved in re-evaluation.
In 2017, the most influential category of Chinese medicines, such as adjuvant medications, key monitoring drugs, clinical pathways, and medical insurance payments, was traditional Chinese medicine injections. It is imperative to study the effectiveness of traditional Chinese medicine injections. Among the three major therapeutic areas with high sales, such as anti-tumor, anti-viral and cardiovascular and cerebrovascular diseases, it is necessary to refer to the current published guidelines for clinical research of new Chinese medicines.
The re-evaluation of traditional Chinese medicine injections is a life-and-death obstacle in the face of many traditional Chinese medicine manufacturers that use single Chinese medicine injections as their main income. After this difficult time, we must start from the accumulation of pharmaceutical research, and it will not be solved overnight.
Chinese medicine classic name: delay in the list
The study of the clinical classics of the traditional Chinese medicine is also the focus of the industry. The catalogue of classic Chinese medicines originally scheduled for release in 2017 has not been released as scheduled.
Among the 100 prescriptions that the author has received, cough, vaginal discharge, diarrhea, edema, asthma and stroke are relatively rare areas of disease.
In terms of dosage form, nearly 70% are decoctions and drinks, 16% are powders, and 12% are pills. This means that manufacturers with Chinese medicine granules and oral solution production lines are more likely to participate in the competition of traditional Chinese medicine classic research.
Among the 100 famous parties, individual names may be kicked out of the list because they contain toxic drugs (such as aconite), the original prescription contains non-pharmacological herbs (such as lotus leaves), and individual resources belong to precious herbs.
The key to the traditional Chinese medicine classics to attract the industry is the “free clinical listing” policy. However, the catalogue was not released as scheduled, and the policy dividend was delayed. Therefore, it is too early to say whether the "cake" of classical Chinese medicine can be eaten or eaten.
The development of traditional Chinese medicine will enter a new chapter, but due to the originality of traditional Chinese medicine in the world, I am afraid that all manufacturers must touch the stone to upgrade.
The counterattack of traditional Chinese medicine requires modern pharmacy research in place, and the accumulation of clinical basic data is sufficient, and it is possible to change from quantitative to qualitative.
Japanese companies' research on Chinese medicine is worthy of study by Chinese companies. In September last year, Ping An took a stake of RMB 1.6 billion to Tsumura, the largest Japanese herbal medicine manufacturer in Japan. Domestic Chinese medicine companies may consider investing in Japanese Han companies to obtain quality resources.