Inherit For Three Thousand Years

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

Just like what Ping Junwu suggested, the drug cost of Tianwang Huxin Pill is not high. If there is no progress in a short period of time, it is really a bit worth the candle to waste Hu Jiazhen's energy on this aspect.

He thought for a while and said: "Since it is difficult to make a greater breakthrough in a short period of time, Professor Hu will not be responsible for this matter in the future, and you will arrange another person to be in charge of further research and development. Further improve the Heavenly King's heart protection The efficacy of Dan is no longer the most important thing for the company. Professor Hu's original research and development projects are 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 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 thinking, he made some progress during this period.

The prospect of this drug is also very great, not inferior to Tianwang Huxin Dan. 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 Tianwang Huxin Dan no longer needs an authoritative expert like Professor Hu to be in charge. It is also possible to replace it with a researcher with less ability. It is nothing more than the length of time.

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

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

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

Professor Hu has been researching cardiovascular and 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 Dan has basically been completed, he still hopes to focus on the original There is research.

"The research and development of Tianwang Huxin Pill has basically been completed, how long will it take before it can be put into 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 so long? What are the processes?" Xiao Yao knew that it took a long time for a drug to be launched, but he didn't expect it to be so long.

"Tianwang Huxin Pill is a Chinese patent medicine,

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 research and development to production and marketing. In recent years, the pharmaceutical market has changed rapidly, and various uncertainties are very large. Therefore, it can be said that new drug research and development is a long-term development cycle and a large investment , System engineering with many unpredictable factors and high risk.

After the approval of a new drug project comes clinical research.

Generally, the research and development process for Chinese medicine varieties is as follows:

Small-scale product→preliminary drug efficacy screening→chemical composition research→prescription, drug effect screening→pharmacology and toxicology→pharmaceutical preparation research→quality standard→pilot scale-up→stability experiment→data collation and submission for approval.

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

When it comes to process preparations, quality standards and stability tests, even the simplest varieties generally require 12-24 months of research; therefore, basically 24 to 36 months of research are required.

The key that may affect the time at this stage is the chemical composition research and pharmacodynamics research of raw materials. There are many uncertain factors, and whether it goes smoothly determines the length of time.

The pre-clinical research and development of drugs must be thoroughly researched, which is not only conducive to obtaining approval as soon as possible with as little or no supplementary information as possible after declaration, but also conducive to smooth production and marketing after approval in the future.

After the clinical research, the cde is waiting for clinical approval.

According to the relevant provisions of the Drug Registration Management Measures, the Provincial Bureau completes the form review of the materials and on-site registration verification within 30 days, but it may take more than 30 days due to supplementary materials and other matters. National Bureau of CDE new drug clinical trials is 90 days; varieties that are allowed to enter the special approval process is 80 days.

However, because there are too many types of declarations and the tasks of the CDE are too heavy, after the general declaration materials are delivered to the CDE, they have to wait in line for trial, and the time for waiting in line for trial can be short or long. Under normal circumstances, one year is the fastest time for the clinical approval to be approved, and it may take two or three years, depending on the circumstances.

Next, the next stage is clinical trials.

Half a year basically refers to the bioequivalence test, which is applicable to generic drugs; about 3 years is based on the different clinical trials of various new drug categories for phase 1, 2, 3, and 4 clinical trials depending on the category. For clinical trials, the key 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.

The next step is cde to be produced in batches.

In the Drug Registration Management Measures, it takes 150 days to declare the production of new drugs; it takes 120 days for varieties that are approved to enter the special approval process. This time limit is the review time limit, that is to say, the time limit for entering the CDE to start the review, which is the same as the CDE pending clinical approval, and needs to be queued for review. After the cde review is completed, it will be sent to the National Bureau for approval, approved for production, and approved by the National Pharmaceutical Bureau. In general, it is the fastest time to be approved within one year.

The next procedure is the transfer of production batches.

This process is controllable by the enterprise, mainly including trial production, declaring prices for listing, etc. If GMP certification is required, it can be completed in basically 6 months.

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

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

Therefore, it will take more than 8 years for a new drug to go through all the processes, and it will require 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\u0026D and 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 such a long time for a new drug from project approval to launch. This is too long, which makes him a little unacceptable.

ps: Thanks for the old iron love is hard to reward with 588 coins! @B