After listening to Hu Jiazhen's explanation, Xiao Yao felt that he might be too strict, and even the effect of the laboratory trial drug was far from the sample, let alone large-scale industrial production.

Just like Ping Junwu suggested, the cost of the medicine of the Heavenly King Heart Protector Pill is not high, if there is no progress in a short period of time, it is really a bit worth the loss to waste Hu Jiazhen's energy in this aspect.

He thought for a while and said, "Since it is difficult to make a greater breakthrough in a short period of time, then Professor Hu will not be responsible for this matter in the future, and you will arrange another person to be responsible for further research and development." Further improving the efficacy of Tianwang Heart Protector is no longer the most important thing for the company, Professor Hu's original R&D project is also very important, maybe further breakthroughs will be made soon, Professor Hu should turn his energy back to the original project. ”

Before Xiao Yao joined the company, Professor Hu had been responsible for the research and development of cardiovascular and cerebrovascular drugs, although the research and development was not successful in the end, but after changing his thinking, there was some progress during this time.

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

The further research and development of the Heavenly King Heart Protector Pill no longer needs to be in charge of an authoritative person like Professor Hu, and it is also competent, and it is just a matter of time.

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

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

Ping Junwu thinks that the medicinal effect of the Heavenly King Heart Protection Pill is already perfect, although it is a little different from the sample provided by the boss, but compared with similar products on the market, the advantage is extremely obvious, and it can be said that there is no opponent.

Professor Hu has been researching cardiovascular and cerebrovascular drugs for nearly 5 years, and has accumulated a lot of experience in this area.

"The research and development of the Heavenly King Heart Protector Pill has basically ended, how long will it take to be able to put it into the market?" Xiao Yao really didn't know much about this problem.

"If it goes well, it will take about eight years in Japan. Ping Junwu replied.

"Is it going to take so long? What is the process?" Xiao Yao knew that it took a long time for drug development to be marketed, but he didn't expect it to take so long.

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

It takes a long time for a new drug application to be approved from R&D to production and marketing, and the pharmaceutical market has been changing rapidly in recent years, and various uncertainties are very large, so it can be said that new drug R&D is a systematic project with a long development cycle, large capital investment, and many unpredictable factors, and has high risks.

After the establishment of a new drug, there is a clinical study.

Generally, the R&D process for traditional Chinese medicine varieties is as follows:

Small-scale products→ preliminary efficacy screening→ chemical composition research→ prescription, efficacy screening→ pharmacology and toxicology→ pharmaceutical process preparation research→ quality standards→ pilot scale-up→ stability experiments→ data collation and approval.

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

Even the simplest varieties generally require 12-24 months to enter the process of process preparation, quality standards and stability tests, so it basically takes 24 to 36 months to study.

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

The preclinical research and development of drugs must be thoroughly studied, which is not only conducive to the issuance of as little or even no supplemental information after the declaration, and to be approved as soon as possible, but also conducive to the smooth production and marketing after approval in the future.

The clinical study is followed by the CDE clinical trial.

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 verification of registration within 30 days, but it may take more than 30 days due to supplementary information and other matters. The clinical trial of CDE new drugs by the National Bureau of China is 90 days, and the varieties approved for special approval procedures are 80 days.

However, due to the fact that there are too many varieties to be declared and the task of CDE is too heavy, after the general application materials are delivered to the CDE, they need to queue up for review, and the queuing time for review can be short or long. Under normal circumstances, 1 year for clinical approval is the fastest time, maybe 2 years, 3 years, and there are various situations.

Next, the next stage is clinical trials.

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

Next is the CDE ready for batch production.

According to the Measures for the Administration of Drug Registration, it takes 150 days to declare the production of new drugs, and 120 days for varieties that are allowed to enter the special approval procedure. This time limit is the review time limit, that is, the time limit for entering the CDE to start the review, which is the same as the CDE pending clinical approval, and needs to queue up for review. After the CDE review, it will be sent to the National Bureau for approval and production, and the national medicine approval will be obtained. In general, it is the fastest time to get approved in 1 year.

The next procedure is the transfer of production approvals.

This process is controllable by the enterprise, mainly trial production, declaration of price listing, etc., if GMP certification is required, it can be completed in 6 months.

Generally speaking, when enterprises apply for new drugs, the main difficulties in project establishment, preclinical research, clinical trials, etc., lie in technical research and research, which is controllable to a certain extent.

After the information is sent to the State Bureau, judging from the current time limit for approval and the queuing of many enterprises for approval, the long waiting period makes enterprises suffer.

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

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

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 from project approval to listing, which was too long, which made him a little difficult to accept.

PS: Thank you Lao Tie for falling in love, it's hard to reward 588 coins!