CFDA launches biosimilar drug research technical guidance work
In the pharmaceutical market, many drugs with significant efficacy have some similar drugs with similar functions, which play a significant role in the treatment of some diseases. Recently, the CFDA launched a special work on the development of biosimilar drug research technology guidelines, which is an encouraging news.
CFDA launches biosimilar drug research technical guidance work
"When formulating the specifications for biosimilar drugs in China, how can we reduce the application process, save time and cost in research and development, clinical time, and ensure the consistency with the original drug, which will be a challenge for China's drug regulatory authorities. "Sang Guowei, chairman of the Chinese Pharmaceutical Association and academician of the Chinese Academy of Engineering, pointed out at the "High-level Seminar on Biosimilar Drug Policies and Regulations and Technical Guidelines."
At present, in the pharmaceutical industry, there is no clear classification requirement for domestic biosimilar drugs, and there is no public technical review requirement. Applicants and review agencies do not have a unified understanding of their technical requirements. Dr. Sun Zuoyu, Executive Director of Cinda Biopharmaceutical Quality Department, said that there is no difference in the process and time limit for the review of biosimilar drugs and innovative drugs. The lack of time advantage and more expensive conditions hindered the development of biosimilar drugs in China.
Twenty-two countries or organizations around the world have successively formulated and promulgated their biosimilar drug-related guidelines, and the principles followed are all WHO recommendations and EMEA specifications. Su Ling believes that how to combine China's specific national conditions without losing the opportunity to connect with the requirements of advanced countries and international consensus is an opportunity to encourage the development of high-quality high-quality biosimilar drugs and promote the healthy development of China's bio-pharmaceutical industry.
With the continuous development of the pharmaceutical industry, a large number of new types of pharmaceuticals continue to emerge, playing a significant role in the treatment of diseases. Medical investment sources pointed out that the special work of the CFDA-initiated bio-similar drug research technical guidelines will allow more new drugs to emerge and make a huge contribution to the medical community.
CFDA launches biosimilar drug research technical guidance work
"When formulating the specifications for biosimilar drugs in China, how can we reduce the application process, save time and cost in research and development, clinical time, and ensure the consistency with the original drug, which will be a challenge for China's drug regulatory authorities. "Sang Guowei, chairman of the Chinese Pharmaceutical Association and academician of the Chinese Academy of Engineering, pointed out at the "High-level Seminar on Biosimilar Drug Policies and Regulations and Technical Guidelines."
At present, in the pharmaceutical industry, there is no clear classification requirement for domestic biosimilar drugs, and there is no public technical review requirement. Applicants and review agencies do not have a unified understanding of their technical requirements. Dr. Sun Zuoyu, Executive Director of Cinda Biopharmaceutical Quality Department, said that there is no difference in the process and time limit for the review of biosimilar drugs and innovative drugs. The lack of time advantage and more expensive conditions hindered the development of biosimilar drugs in China.
Twenty-two countries or organizations around the world have successively formulated and promulgated their biosimilar drug-related guidelines, and the principles followed are all WHO recommendations and EMEA specifications. Su Ling believes that how to combine China's specific national conditions without losing the opportunity to connect with the requirements of advanced countries and international consensus is an opportunity to encourage the development of high-quality high-quality biosimilar drugs and promote the healthy development of China's bio-pharmaceutical industry.
With the continuous development of the pharmaceutical industry, a large number of new types of pharmaceuticals continue to emerge, playing a significant role in the treatment of diseases. Medical investment sources pointed out that the special work of the CFDA-initiated bio-similar drug research technical guidelines will allow more new drugs to emerge and make a huge contribution to the medical community.
Zhejiang Industrial Group Co., Ltd. , https://www.xingyeseafood.com