12 new drugs were approved, and the road of inheritance, innovation and development of traditional Chinese medicine has gone smoothly

In 2021, the State Food and Drug Administration approved 12 new Chinese medicine drugs (including 9 innovative drugs) to be launched, hitting a new high in the past five years
.
Relevant drugs cover the treatment fields of diseases such as the respiratory system and digestive system, and the holders of drug marketing licenses have both "leaders" and "dark horses", and the reform of the Chinese medicine review and approval system has achieved initial results
.
In this regard, Du Shouying, director of the Department of Traditional Chinese Medicine, School of Traditional Chinese Medicine, Beijing University of Traditional Chinese Medicine, pointed out that in recent years, the State Food and Drug Administration has established a sound traditional Chinese medicine review and approval mechanism that conforms to the characteristics of traditional Chinese medicine, which has effectively promoted the increase in the number of new drug applications and approvals
.
"The approval of a number of innovative drugs has released an important signal, which will greatly stimulate the enthusiasm of enterprises for research and development and the upsurge of capital investment
.
The future of the traditional Chinese medicine industry can be expected
.
" Xuan Xuan, vice chairman of the New Technology Committee of Traditional Chinese Medicine of China Association of Traditional Chinese Medicine and professor of Shanghai University of Traditional Chinese Medicine Zhenyu said happily
.
In order to promote the inheritance, innovation and development of traditional Chinese medicine, the State Food and Drug Administration not only improves the system, optimizes the mechanism, but also strengthens the service
.
"We summarize the experience of 'research and review linkage' in emergency approval of new coronary pneumonia epidemic prevention and control drugs, clarify how and how to do innovative research and development of traditional Chinese medicine, and provide enterprises with 'point-to-point' technical guidance and registration services
.
" Relevant staff of the State Food and Drug Administration Said that the State Food and Drug Administration, guided by clinical value, guides enterprises to identify clinical positioning, conduct scientific research, obtain reliable evidence, and help the development of new Chinese medicines
.
The new traditional Chinese medicines approved by Gufangjiexinguo in 2021 are all changed from "prescription" to "medicine", and the transformation is a vivid practice of "originating from the clinic and returning to the clinic", which also means that the traditional Chinese medicine registration classification reform proposed.
The registration and review path is gradually going through
.
Take the Jieyu Chufan Capsule of Shijiazhuang Yiling Pharmaceutical Co.
, Ltd.
as an example.
This product is developed on the basis of clinical experience.
The recorded Gardenia Houpu Decoction was made from the cut, and a randomized, double-blind, positive control drug (chemical drug), placebo parallel controlled, multi-center clinical trial was carried out.

.
In the opinion of Li Xiangjun, vice president of Yiling Pharmaceutical Research Institute, the development of this product is of reference significance for mining new drugs from ancient classic prescriptions.
Positioning has laid a solid foundation for drug development; in the later stage, the company conducted rigorous research in accordance with the registration requirements, and obtained systematic and sufficient evidence
.
Under the new review and approval mechanism, R&D enterprises are boldly innovating and rigorously verifying
.
At the same time, the State Food and Drug Administration's front-line service, research and review linkage, so that the innovative research and development of traditional Chinese medicine can avoid detours
.
Yinqiao Qingre Tablets of Jiangsu Kangyuan Pharmaceutical Co.
, Ltd.
was approved for marketing in November 2021, and it is the first Chinese medicine innovative drug declared under the category 1.
1 innovative drug since the implementation of the new Chinese medicine registration classification in 2020
.
"During the registration and application process, the Drug Evaluation Center of the State Food and Drug Administration (hereinafter referred to as the Drug Evaluation Center) took the initiative to guide us to improve the information according to the new requirements, and also organized a communication meeting to invite experts and enterprises to have face-to-face communication on key technical issues.

"Introduced by Zhang Chenfeng, R&D Director of Kangyuan Pharmaceutical
.
The research and development of Qizhi Yishen Capsule, an innovative drug of Shandong Phoenix Pharmaceutical Co.
, Ltd.
, took nearly 20 years
.
"When we started to develop this product, we knew that diabetic nephropathy was harmful and had many patients, but we lacked sufficient understanding of traditional Chinese medicine innovation and underestimated the difficulty of innovative research and development,
" said Shang Guichun, deputy general manager of the company
.
Because of this, enterprises have a deeper feeling for the active service of the drug regulatory department
.
In the process of product research and development, Phoenix Pharma has obtained various guidance and assistance from drug regulatory departments at all levels: when conducting Phase II and Phase III clinical trials, the Shandong Provincial Food and Drug Administration instructs enterprises to select clinical trial institutions; in the process of formulating quality standards During the period, Shandong Institute of Food and Drug Inspection responded to the inquiries of enterprises in a timely manner; in the registration application stage, the Drug Evaluation Center communicated closely with enterprises to help enterprises accurately grasp the requirements of registration regulations.
.
.
"In the process of technical review, sometimes I get off work at night.
Now, the staff of the Drug Evaluation Center also called to tell us what materials we need to add and what problems to explain.

.
"Shang Guichun was deeply impressed by the work >
.
In fact, in the systematic project of innovative research and development of traditional Chinese medicine, the State Food and Drug Administration actively mobilized the resources of the whole system and tried to help in all directions
.
The reporter learned that the drug of the State Food and Drug Administration The Registration Management Department and the Drug Evaluation Center and other directly affiliated units have established a working mechanism to follow up the review progress every month, and coordinate to solve the difficulties encountered in the verification and inspection of related varieties
.
In addition, the State Food and Drug Administration is also closely related to the provincial drug administration.
Contact, guide the provincial drug administration to intervene in advance, strengthen guidance, and effectively solve the problems and challenges faced by enterprises
.
Build a new system In the development of new Chinese medicines, regulatory authorities and enterprises have reached a consensus, that is, to use modern scientific language to explain Chinese medicines
How to explain clearly how Chinese medicine can be effective? "Three combination" is a breakthrough .

"Three combination" refers to the traditional Chinese medicine registration review evidence system that combines the theory of traditional Chinese medicine, human experience and clinical trials.
The principle of inheriting the essence, keeping upright and innovative, respecting the theory of traditional Chinese medicine and traditional drug use experience, meets the needs of the inheritance, innovation and development of traditional Chinese medicine
.
The State Food and Drug Administration optimizes the review strategy around the "three combinations", and the research and development of new traditional Chinese medicines does not insist on "nodding from the guinea pig".
It has won unanimous praise from the industry
.
"Compared with the past, the current thinking of traditional Chinese medicine evaluation has achieved a complete innovation
.
For example, Xuan Zhenyu said that the reformed review ideas have broken the evaluation method based on component theory, strengthened the supporting role of human experience, and more in line with the actual development of traditional Chinese medicine.
Disease areas where traditional Chinese medicine has therapeutic advantages can make a big difference
.
Building a "three-in-one" registration review evidence system and promoting the formulation and revision of technical guidelines for traditional Chinese medicine evaluation are the highlights
.
According to statistics, since 2020, the Center for Drug Evaluation has released more than ten traditional Chinese medicine pharmacology The technical guiding principles and the establishment and improvement of the whole-process quality control system for new traditional Chinese medicines have not only strengthened the guidance for the research and development of enterprises, but also further standardized the review work
.

.
"Shang Guichun told reporters that the improvement of the technical guiding principle system has made the company's research and development activities more targeted
.
The direction of the company's efforts is consistent with the review thinking, and the research and development is more efficient
.
These guiding principles have been fully researched during the formulation process and widely listened to the industry.
Expert opinion
.
In the process of formulating and revising the relevant guiding principles, at least three levels of discussions must be conducted within the drug regulatory department, experts and scholars from scientific research institutions, and representatives of industry and enterprise experts, and gradually improve in the process of full discussion
.
The chairman of New Drug Development Co.
, Ltd.
has participated in relevant discussions as an expert in scientific research institutions and a representative of enterprises
.
He spoke highly of this progressive model of formulating and revising guiding principles
.
He said: "Every step of the Drug Evaluation Center Work is solid
.
The suggestions put forward by some companies and researchers are very down-to-earth and have been fully valued and absorbed by the Center for Drug Evaluation
.
The published guidelines incorporate expert and industry advice and are more enforceable
.
Stimulating new momentum The State Food and Drug Administration has played a combined punch to promote the inheritance, innovation and development of traditional Chinese medicine, which has stimulated the vitality of traditional Chinese medicine innovation.
The number of clinical trials and marketing applications of new traditional Chinese medicines has shown a trend of recovery
.
From 2020 to 2021, there will be 2, 4, and 12 respectively
.
"The development of traditional Chinese medicine coincides with the best period, and the regulatory authorities can continuously introduce appropriate policies and measures to provide a strong guarantee for the development of innovative drugs
.
We have no doubts about this and will continue to promote innovative research and development along the established direction
.
"Li Xiangjun's words express the common aspirations of Chinese medicine companies
.
Xuan Zhenyu observed that in addition to Chinese medicine companies, companies with chemical medicine as their main business also show great enthusiasm for the innovative research and development of traditional Chinese medicine.
The enthusiasm
of enterprises comes from Confidence in the development prospects of the industry
.
Xuan Zhenyu said that although the technical standards for innovative traditional Chinese medicine drugs have been raised, these standards are the consensus of the whole industry and are not unattainable
.
The most important thing is that the drug regulatory department has given clear technical evaluation requirements, and the research and development activities are more rules-based
.
"Most technical problems can be solved when the R&D philosophy and the review philosophy are aligned,
" he added
.
Zhang Chenfeng said that traditional Chinese medicine has unique advantages in the treatment of many diseases.
Through in-depth research, innovative traditional Chinese medicines with clinical value can be developed
.
Even for the common cold and frequently-occurring disease, the existing Chinese patent medicines generally have a long onset time, a long medication cycle, and new drugs with strong efficacy and specificity still have good application prospects
.
This is also an important reason why Kangyuan Pharmaceutical dares to continuously invest in innovation
.
Shang Guichun clearly felt that all the elements of the whole chain of traditional Chinese medicine innovation and R&D have been mobilized, and the innovation and R&D environment has become more friendly
.
He said: "In the past, there were very few R&D institutions and contract research organizations specializing in the development of traditional Chinese medicine.
Now the situation has been greatly improved
.
" The "athletes" showed great enthusiasm, and the "referees" returned with the greatest sincerity
.
Three projects in the second batch of key projects of the China Drug Regulatory Science Action Plan are directly related to the evaluation of traditional Chinese medicine.
)”, etc.
, and seminars related to the “Three Combinations” are frequently conducted.
.
.
The reform of the review and approval system for traditional Chinese medicines has been further promoted
.
"With the deepening of reform, the detailed policies expected by the industry will be gradually matched
.
" The relevant person in charge of the Center for Drug Evaluation said that in light of the actual problems encountered in the review, the Center for Drug Evaluation is organizing the formulation of guiding principles to further clarify the "three-in-one combination".
"The research and development strategy of new traditional Chinese medicine under the registration review evidence system
.
In addition, in response to the hot issues of traditional Chinese medicine registration applications such as how to collect and organize human experience, the Drug Evaluation Center has selected three specific indications of malignant tumor, chronic gastritis, and gastroesophageal reflux disease as breakthrough points after special investigation, and introduced new real-world research and other new New tools and methods, together with authoritative experts in the field of TCM clinical related indications, are tackling key technical requirements for clinical efficacy evaluation that meet the characteristics of TCM
.
The reporter also learned that the State Food and Drug Administration is summarizing the reform experience, accelerating the construction of a review and approval system that conforms to the characteristics of traditional Chinese medicine, and assisting the inheritance, innovation and development of traditional Chinese medicine
.