In the first half of 2021, the number of approved innovative drugs in my country sets a new record

In the first half of 2021, China approved 21 innovative drugs

How to realize new drug review quickly and well? “It’s not just half a year’s work

"The improvement of the efficiency of drug review and the enhancement of the scientific level of drug supervision have jointly promoted the development of China's pharmaceutical innovation

The "new" tide is surging, and the reform effect is evident

"If there is no drug review reform and efficient review by the drug review center, it will be difficult for our two original innovative drugs that patients urgently need to be listed this year

The timeline is the lifeline, which is true for innovative companies, and even more so for patients suffering from diseases

In Kong Fanpu's view, it is very important to speed up the market registration process for the four drugs of breakthrough therapy, conditional approval, priority review and approval, and special approval procedures

This is a tangible measure to benefit enterprises

Through adequate communication, the Center for Drug Evaluation clearly conveys the review considerations and technical requirements to the enterprise, laying a good foundation for the efficient review of clinically urgently needed products

　　The spinal muscular atrophy (SMA) treated by this product is a genetic disease that is currently incurable.

　　"Through early communication in clinical research and development, we recommend that the original research company start clinical trials in China as soon as possible to provide data support for scientific decision-making in drug review

　　The "blade" is inward, and management is for efficiency

　　In the first half of 2021, with the year-on-year increase in the number of drug registration application tasks and the high technical content of the declared varieties, the overall completion rate of the innovative drug-related tasks of the Center for Drug Evaluation exceeded 90% within the time limit

　　Drawing on the experience of emergency review and approval of anti-epidemic-related vaccine drugs, the Center for Drug Evaluation has made every effort to accelerate the listing of clinically urgently needed drugs on the basis of scientific review

　　It is the philosophy of the Center for Drug Appraisal not to let new drugs that are urgently needed in clinical trials get stuck in the review process

　　According to Kong Fanpu, the drug review center establishes a working mechanism, starting from application acceptance, task assignment, professional review, communication, inspection and testing, etc.

　　"One-off issuance is something that makes the industry happy

　　Comparing with international standards and perfecting the system of technical guidelines based on China's actual conditions, the Center for Drug Evaluation has set itself "hard targets"

　　These guiding principles are related to the research and development and innovation of vaccine drugs, children's medicines, traditional Chinese medicines, and anti-tumor drugs related to the fight against the new crown pneumonia epidemic
.
The Center for Drug Evaluation encourages experts from all parties to participate in the formulation and revision of the work, so that the guiding principles fully condense the consensus of domestic and international industry enterprises; for the guidance principles such as the new coronavirus vaccine that the industry urgently needs, the Center for Drug Evaluation will give them to R&D companies before the official release.
Improve the content in the middle
.

　　"Improve the guiding principle system, which not only clarifies technical requirements, guides and standardizes the R&D behavior of the entire industry, but also answers doubts for enterprises to avoid detours in R&D
.
" Fang Jianmin, for example, said that Vidicuzumab for injection was independently developed by China.
Innovative antibody conjugate drugs, which have little experience in research and development.
In 2020, the "Guiding Principles for the Preparation of Safety Summary Materials for Anti-tumor Innovative Drugs" and other guiding principles are solicited for comments, which largely provides reference for enterprises and solves urgent needs
.

　　Steady and steady to help high-quality innovation

　　Among the innovative drugs approved in the first half of 2021 is the First-in-Class of its kind.
This is the third consecutive year that China has had First-in-Class innovative drugs approved for marketing since 2019; including 3 new coronavirus vaccines, China's new coronavirus vaccine research and development ranks first in the world
.

　　This is like a microcosm, showing that China's drug review system has been accelerating on the international track since its reform
.
From 2015 to 2020, China has built a relatively complete pharmaceutical innovation ecosystem, with various innovation elements interacting and a virtuous circle.
From the third echelon of global pharmaceutical innovation to the forefront of the second echelon, China has an impact on the number of global R&D pipeline products.
Contribution jumped to about 14%, ranking second in the world
.

　　High-level drug review institutions and high-quality medical innovation support and promote each other
.
The continuous release of China's pharmaceutical innovation efficiency has placed more expectations and higher requirements on drug review institutions
.

　　Fang Jianmin expects that China can continue to improve the supporting measures of laws and regulations, accelerate the construction and implementation of the electronic general technical documentation (eCTD) system for pharmaceuticals, and continue to promote the further integration of pharmaceutical registration technical standards with international standards
.

　　Song Ruilin suggested that in the future, we must adhere to focusing on the clinical value of drugs, continue to refine and improve the review technical guidelines, and establish and improve a high-standard, high-level review system that is in line with China's actual situation
.

　　Many of these tasks are continuously carried out by the Center for Drug Evaluation
.
In the four years since the National Drug Administration joined the International Technical Coordination Committee for the Registration of Human Drugs (ICH), China has fully implemented more than 70% of the ICH guidelines
.
"The China Council for the Promotion of Pharmaceuticals has done a lot of cooperation in promoting the implementation of the ICH guidelines.
I deeply feel the determination and strength of the drug review center to implement the drug review reform policy, and realize that the international level of China's drug regulatory work has further improved
.
" Song Ruilin gave Out of praise
.

　　Some jobs have been put on the agenda
.
To promote the coordinated development of all aspects of the eCTD project, the Center for Drug Evaluation has been conducting system information security assessments this year, drafting relevant technical documents, sorting out China's existing electronic filing experience, and then speeding up the use of the eCTD system
.

　　Kong Fanpu introduced to reporters that the Center for Drug Evaluation will continue to implement the task requirements for deepening the review system reform while continuing to do a good job in the review of new crown vaccine drugs, strengthen the guidelines and system revision efforts, and further explore the application of anti-epidemic emergency review Experience can effectively promote the innovation and development of the pharmaceutical industry
.

　　Kong Fanpu also stated that he will continue to improve the construction of modern review talents
.
"More and better innovative drugs are emerging, and we objectively require us to expand the size of the review team and improve the capabilities of reviewers
.
" He said that the Center for Drug Evaluation will implement strong reform measures with a strong review team to better satisfy People's health needs
.