What is the process of applying for a national patent for a drug formula? Is it strict?

To tell the truth, this matter is really troublesome. From the procedural point of view, we should apply for a patent first to ensure the exclusiveness of prescription. Patent application is relatively simple. If you apply in your own name, it will take about 2 years, and the official fee is about 1 000 yuan. You'd better find a patent office to do it for you. You are good at programming and writing. There are many people in the company here. Sure, you can call me. The agency fee is different, about 6000 yuan. Besides, cooperation with pharmaceutical companies is more troublesome. The approval of new drugs goes through two processes. Firstly, the review of preclinical research. You need to provide SFDA with the process and results of prescription analysis, preparation technology research, quality standard research, animal efficacy and toxicology research. The whole research and evaluation process takes about 2 ~ 3 years. If approved, I will give you the approval of clinical research, and then find five major hospitals to conduct at least two clinical experiments (that is, for people). It takes about 1 year, and then report the clinical trial results to the Food and Drug Administration. If they pass, they will send you a new drug certificate and a drug production approval, so that you can produce this drug. The cost of preclinical research is about 6.5438+0 million; The cost of clinical research depends on the disease, at least 3 million. Nowadays, pharmaceutical companies rarely invest from scratch because the results are uncertain and the risks are too great. They prefer to ask for a production license directly. At least they have to see the approval of clinical research before they can invest in clinical research. Unless your prescription really has an excellent effect, you can convince the pharmaceutical factory that this is a good variety to create the market. But it's hard. That's all I can say. Whether it can be developed into a new drug is whether it is necessary to apply for a patent. Think for yourself ~ ~ ~