-
Categories
-
Pharmaceutical Intermediates
-
Active Pharmaceutical Ingredients
-
Food Additives
- Industrial Coatings
- Agrochemicals
- Dyes and Pigments
- Surfactant
- Flavors and Fragrances
- Chemical Reagents
- Catalyst and Auxiliary
- Natural Products
- Inorganic Chemistry
-
Organic Chemistry
-
Biochemical Engineering
- Analytical Chemistry
-
Cosmetic Ingredient
- Water Treatment Chemical
-
Pharmaceutical Intermediates
Promotion
ECHEMI Mall
Wholesale
Weekly Price
Exhibition
News
-
Trade Service
Thanks to the release of the dividends of drug review reforms, a large number of domestic innovative drugs have emerged in recent years.
A series of market reforms and new regulatory policies have also fully demonstrated the efforts made by China’s drug review departments, clinical researchers and pharmaceutical companies to meet medical needs and protect people’s health.
Outstanding contribution
.
During the 4th China International Import Expo, the event "Enhancing Life, Talking about "China Research"" was successfully held.
Industry experts from regulatory agencies, medical institutions, and pharmaceutical companies discussed the reform of the review and approval system and the achievements of China's pharmaceutical innovation and upgrading
.
To improve the level of local clinical diagnosis and treatment in China and accelerate the innovation process of "China Research", many parties in the industry are cohesive
Research and development to create new ecological accelerate the process of innovation in China
Research and development to create new ecological accelerate the process of innovation in China With the deepening of drug regulatory reform, China's pharmaceutical industry has entered a new stage of high-quality development, and the people's drug needs have been better met
.
Since 2019, the State Drug Administration has successively promulgated policy documents such as the "Drug Administration Law", "Vaccine Administration Law", "Drug Registration Management Measures", "Production Supervision and Management Measures", which have created more for the innovation, upgrading and high-quality development of the pharmaceutical industry.
According to Yang Jinbo, director of the Yangtze River Delta Branch of the National Medical Products Administration, the number of innovative drugs approved in China has reached 21 in the first half of 2021, surpassing the number in 2020, and also refreshed the review record of innovative drugs in China; this year; On June 3, the China Food and Drug Administration was re-elected as a member of the ICH Management Committee.
Through the issuance of ICH guidelines, the 46 Get on track
.
Focusing on unmet clinical needs, in order to speed up the drug listing and registration procedures, the drug regulatory system has established four accelerated channels for "breakthrough therapeutic drugs", "conditional approval", "priority review and approval" and "special approval", and gradually improved them.
The scope of inclusion, procedures, support policies and other requirements of each channel are discussed
.
Not only did the market see the "China speed" of new drugs being launched, but it also allowed patients to get tangible benefits for diagnosis and treatment
Professor Zhou Caicun, director of the oncology department of Shanghai Pulmonary Hospital affiliated to Tongji University, pointed out that the rapid approval of innovative drugs with better efficacy has significantly improved the clinical prognosis of malignant tumors represented by lung cancer.
The five-year survival rate has increased from 10% in the past to 30%~40%; Accelerate the introduction of overseas high-quality innovative drugs into the country, and promote the development of high-value innovative drugs by local enterprises.
The "Healthy China 2030" planning goal will surely be achieved
.
The encouragement of innovation by national policies has also brought about changes in the pharmaceutical industry for all to see
.
Dr.
"In China For China" focuses on China's clinical needs
"In China For China" focuses on China's clinical needs The transformation of the industrial innovation ecology has ignited the enthusiasm of new drug research and development for capital and the industry.
However, the "clustering" of innovative drug targets and the homogeneity of clinical research have begun to appear
.
Take the oncology field as an example.
Professor Zhou Caicun felt deeply about this.
He said that both product development and clinical research should adhere to the clinical value-oriented approach.
Targets "getting together" and the homogeneity of clinical research are not only unfavorable to standardizing the market, but also a waste of industry and clinical research.
, Public resources
.
"Based on the clinical needs of Chinese patients, many tumors are unique to the Chinese population, such as liver cancer, esophageal cancer, and nasopharyngeal cancer.
With patient needs as the core, drug supervision is gradually raising the threshold of innovation
.
In July of this year, CDE issued the "Clinical Value-Oriented Anti-tumor Drug Clinical Research and Development Guidelines (Draft for Comment)", emphasizing that the clinical needs-oriented concept, Carry out drug research and development centered on patients, so as to maximize the benefits of patients
Director Yang Jinbo pointed out that the core value concept of clinical value-oriented research and development is that from no cure in the past to medicine available now, from the current availability of medicines to the selection of good medicines in the future
.
“Drug R&D should not take registration and marketing as the sole goal.
It is not difficult to see that "In China For China" has become an important strategy for multinational companies to seek localized innovation, and "China Research" can further promote the integration of Chinese innovation into the global value chain
.
Dr.
Li Zhengqing believes that allowing China to synchronize with many countries to obtain the latest breakthrough products in the world, and to promote more Chinese clinical research to join the international multi-center clinical research, this is the focus of R&D work of multinational companies in the new era; from early research and phase I/II Clinical research has begun to integrate global innovative resources, allowing Chinese researchers to learn more about Chinese patients and generate more early research data in China, which will provide assistance for later clinical research and R&D transformation
.
