Chinese medicine research and development, production threshold to raise, the industry or welcome a big shuffle

"Pharmaceutical Network Industry Dynamics" Recently, the State Drug Administration issued the "Chinese medicine registration classification and declaration of information requirements."
It clearly defines the three registered categories of Chinese medicine, such as innovative Chinese medicine, Chinese medicine improved new medicine, ancient classic prescription Chinese medicine compound preparation, etc., and also makes clear the relevant contents of the registration and declaration information of Chinese medicine.
Chinese medicine research and development, production threshold raised, the industry or Yingda shuffle (photo source: pharmaceutical network) it is understood that this is following the end of April this year, the State Drug Administration General Division on the "Chinese medicine registration management special provisions (draft for comments) and other six documents to the industry for comments, on the registration of Chinese medicine another important document."
, it is worth noting that according to the content of the document, the requirements for the research and development and production of standard drugs and biological products have become more standardized and strict, and the standards have been greatly improved.
, like chemicals, biological products, etc., Chinese medicine research and development must also provide a large number of systematic and perfect data, subject to modern scientific means of testing.
this also means that in the future, the cost and pressure of enterprise research and development will be greatly increased, and for the Chinese medicine already on the market, in the research and development and production system consistent requirements, the enterprise GMP system will also face great challenges.
addition, industry insiders believe that under the influence of the above factors, at least 300 billion market reshuffle of Chinese medicine will accelerate the arrival.
, China's further expansion of centralized procurement to Chinese medicine signal will be more and more clear.
, of course, the purpose of the state's policy is not to depress the development of Chinese medicine, but to regulate the development of Chinese medicine.
Traditional Chinese medicine is based on Chinese herbal medicine as raw materials, processed by preparations into a variety of different dosage forms of Chinese medicine products, including pills, dispersion, paste, Dan a variety of dosage forms, clinical repeated use, safe and effective, dosage form fixed, and take a reasonable process to prepare into a stable quality, controllable, approved for production in accordance with the law into a prescription Of Chinese medicine preparations.
is also the essence of the effective square agent created and summarized by chinese medical scientists after thousands of years of medical practice.
in the past few decades, Chinese medicine has gone through a period of brutal growth.
the market size is expanding, annual sales of more than 3 billion varieties of products continue to emerge, but behind it, with gold sales, abuse problems are increasingly prominent.
addition, due to the lack of evidence-based medical evidence, clinical trial data support, adverse reactions, taboos are not clear, the safety and effectiveness of traditional Chinese medicine itself has been questioned.
refore, the industry believes that the State Drug Administration to raise the industry threshold, with volume procurement shuffle, the past good days of Chinese medicine is coming to an end, will begin to move towards more compliant development of the road.
fact, in recent years, the attitude of encouraging the development of Chinese medicine at the national level has become more and more clear, while the relevant departments of the industry norms are indeed escalating.
the new edition of the Chinese Pharmacopoeia, which will be implemented on December 30th, imposes stricter restrictions on Chinese medicine tablets, revises more than 250 quality standards, and imposes more stringent and specific requirements on harmful residues.
addition, the policy of compulsory renaming of Chinese medicine and the incasive opening of Chinese medicine by Western medicine have also caused heated discussion in the industry.
, Chinese medicine is expected to usher in new opportunities for development under the attention and policy support and norms at the national level.
, Chinese medicine will also face more new challenges, such as the integration of traditional Chinese medicine into the national centralized procurement.
background, Chinese medicine enterprises, to have the determination of strong men to break their wrists, in the environment to force enterprises to innovate, standardized development, the need to accelerate the transformation and upgrading, towards the direction of fine operation.