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With the continuous improvement of the availability of anti-tumor drugs, the anti-tumor drugs available to cancer patients have more choices and higher quality than before
.
This article counts the policies and regulations related to the research and development of anti-tumor drugs in recent years for everyone to take a look at
.
PART 0 1.
Overview of the research and development of anti-tumor drug research and development industry Malignant tumors are diseases that seriously threaten human life worldwide and are one of the number one killers of human health.
Many people talk about cancer
.
The number of cancer patients in China ranks first in the world, and the morbidity and mortality rates have continued to rise in recent years
.
The National Cancer Center released the latest issue of national cancer statistics.
The report shows that on average, more than 10,000 people are diagnosed with cancer every day, and 7 people are diagnosed with cancer every minute
.
Among the drug development of various diseases, the research and development of anti-tumor drugs is the field with the largest investment and the fastest new drug market.
According to the statistics of the CDE review report, in 2020 CDE will accept a total of 9,768 applications for registration, of which 60% are anti-tumor drugs.
Oncology drug application, 777 anti-cancer drug clinical trial application projects approved in 2020
.
PART 0 2.
China's policy dividends help the research and development of anti-tumor drugs.
In recent years, in order to overcome the hard bones of tumors, the State Drug Administration has paid great attention to the research and development of anti-tumor drugs.
.
Since China joined ICH in June 2017, domestic regulatory agencies have been in line with international standards, and various guidelines have been close to the requirements of FDA, EMA and other developed countries’ regulatory agencies.
A series of regulatory documents have been issued to accelerate the review of anti-tumor drugs.
Evaluation and approval, including but not limited to: 1 Non-clinical 2 Clinical trials, registration and application, etc.
3 comprehensive drug guide references [1][2] CDE training and publishing articles, etc.