Inherit For Three Thousand Years

After listening to Hu Jiazhen's situation, Xiao Yao felt that he might be too strict. Even the effects of laboratory trial-produced drugs are far from samples, not to mention large-scale industrial production.

Just like Ping Junwu suggested, the cost of the medicine for Tianwang Huxin Pill is not high. If there is no progress in a short period of time, it would be a little more than a loss to waste Hu Jiazhen's energy on this aspect.

He thought for a while, and said: "Since it is difficult to achieve greater breakthroughs in a short time, Professor Hu should not be responsible for this matter. You will arrange another person to be responsible for further research and development. Further enhance the protection of the heavenly king. The efficacy of Dan is not the most important thing for the company. Professor Hu’s original R&D project is also very important. Perhaps further breakthroughs will be made soon. Professor Hu should turn his energy back to the original project. ."

Before Xiao Yao entered the company, Professor Hu had been in charge of the research and development of cardiovascular and cerebrovascular drugs. Although the research and development was not successful in the end, after changing his mind, there was some progress in this period of time.

The prospects of this drug are also very huge, not inferior to the Heavenly King Protecting Heart Pill. Considering that Professor Hu's role is irreplaceable, Xiao Yao decided to let him return to a more important post.

The further research and development of the Heavenly King Heart Protection Pill no longer requires an authority like Professor Hu to be responsible. It is also competent to replace it with a researcher with a lesser ability. It is nothing more than the length of time.

The reason why Xiao Yao insists on further research and development is that he will come up with more proprietary Chinese medicine prescriptions in the future, and every prescription may face this kind of problem. Such research is still very necessary.

Ping Junwu and Hu Jiazhen were very happy about Xiao Yao's decision.

Ping Junwu believes that the efficacy of Tianwang Huxin Pill is perfect. Although it is a little bit different from the sample provided by the boss, it has obvious advantages compared with similar products on the market, and it can be said that it has no rivals.

Professor Hu has been researching cardio-cerebrovascular drugs for nearly 5 years and has accumulated a lot of experience in this area. Now that the industrialized research and development of Tianwang Huxin Pill has basically ended, he still hopes to put his energy into the original There is research.

"The research and development of the Heavenly King Heart Protection Pill has basically ended. How long will it take before it can be put on the market?" Xiao Yao is really not very clear about this issue.

"If it goes well, it will take about 8 years in China." Ping Junwu replied.

"Does it take such a long time? What are the processes?" Xiao Yao knew that it took a long time from drug development to market, but he did not expect it would take such a long time.

"Tianwang Huxin Pill is a Chinese patent medicine, and the time is short..." Ping Junwu began to introduce the development process and cycle of new Chinese medicine drugs in detail.

It takes a long time for a new drug application to be approved from R&D to production. In recent years, the pharmaceutical market has changed rapidly and various uncertain factors are very large. Therefore, it can be said that new drug R&D is a long development cycle and large capital investment. , System engineering with many unpredictable factors and high risk.

After the new drug project is approved, clinical research is followed.

The general research and development process for Chinese medicine varieties is as follows:

Small-scale product → preliminary efficacy screening → chemical composition research → prescription and efficacy screening → pharmacology and toxicology → pharmaceutical process preparation research → quality standard → pilot scale up → stability experiment → data sorting and approval.

Since this process is a process from discovering the potential value of medicinal raw materials to confirming their development value, a large amount of multidisciplinary basic research on medicinal raw materials is required, and this process takes 1-2 years.

Entering the process formulation, quality standard and stability test, even the simplest variety generally requires a 12-24 month research process; therefore, it basically takes 24 to 36 months to research.

The key that may affect the time at this stage is the chemical composition research and pharmacodynamic research of the raw materials. There are many uncertain factors, and whether it is smooth or not determines the length of the time.

The pre-clinical research and development of drugs must be thoroughly researched, which will not only help to issue as little supplemental materials as possible or even not to issue supplements after application, but also to obtain approval as soon as possible, which is more conducive to smooth production and marketing after approval in the future.

After clinical research, CDE is pending clinical approval.

According to the relevant provisions of the Drug Registration Management Measures, the Provincial Bureau will complete the formal review of the materials and the on-site registration verification within 30 days, but it may take more than 30 days due to supplementary materials and other matters. The clinical trial of CDE new drugs by the National Bureau is 90 days; the varieties that are allowed to enter the special approval procedure are 80 days.

However, because there are too many varieties to be declared, the CDE task is too heavy. Generally, after the application materials are delivered to the CDE, they need to be queued for review. The queue for review can be short or long. Under normal circumstances, one year is the fastest time for a clinical approval document to be approved, and it may take two or three years, in various situations.

Next, the next stage is clinical trials.

Half a year basically refers to the bioequivalence test, which is suitable for generic drugs; about 3 years is the different clinical trials of various new drug categories in phase I, II, III, and IV clinical trials according to different types of new drugs. For clinical trials, the key is to find the drug clinical research institution, choose a clinical institution with a good reputation and rich experience, and the design of the clinical plan directly affects whether it is approved.

The next step is CDE pending batch production.

According to the Drug Registration Management Measures, it is 150 days for new drug production to be declared; 120 days for products that are allowed to enter the special approval procedure. This time limit is the review time limit, that is to say, the time limit for entering the CDE to start the review is the same as the CDE pending clinical trial, which needs to be queued for review. After the CDE review is over, it will be sent to the National Bureau for approval, approved for production, and approved by China National Medicines. Generally speaking, it is the fastest time to be approved in one year.

The next procedure is the transfer of production batches.

This process can be controlled by the enterprise, mainly for trial production, declaration of commodity prices, etc. If GMP certification is required, it can be completed within 6 months.

Generally speaking, when companies apply for new drugs, the main difficulty lies in technical research and research in terms of project approval, preclinical research, and clinical trials, which are controllable to a certain extent.

After the information was sent to the National Bureau, judging from the current time limit for examination and approval and the queuing situation of many enterprises for approval, the long waiting period has caused enterprises to suffer.

Therefore, it takes more than 8 years for a new drug to complete all the processes, and it also has to invest huge human and financial resources and face unpredictable risks.

Only strong and strategic companies are willing to invest in new drug research and development. And companies that take the road of R&D innovation often end up becoming leaders in the industry.

After listening to Ping Junwu's introduction, Xiao Yao was a little dumbfounded. He didn't expect that it would take so long for a new drug to go on the market. It was too long, which made him a little unacceptable.

PS: Thanks to the old iron, it is difficult to reward 588 coins for love!