Human experiment: It is divided into 4 stages in total:

The first phase mainly tests the safety, major side effects, metabolic mechanism, etc. of the drug, and the sample size is generally less than 00. The second phase mainly tests the effectiveness of the drug to determine whether it can effectively act on the human body. Meanwhile, the safety and toxic side effects of drugs are also objects of close observation.

The sample size of the second-phase experiment is generally less than 300. If the second-phase experiment is encouraging, a larger sample will be prepared for testing and the experiment will proceed to the third phase.

The third phase will cover different age groups, different populations, and different dosages to comprehensively study the safety and efficacy of the drug. The sample size of the third-phase experiment ranges from several hundred to several thousand.

Phase Four is mainly conducted after the approval of new drugs, mainly testing the long-term safety of the drugs, new populations, etc.

2. New Drug Application (NDA):

When the pharmaceutical company completes human experiments and verifies the safety and effectiveness of the new drug, it officially submits an NDA application to the FDA. The FDA reviews all animal and human experimental data, as well as the drug's substitution mechanism data and GMP data for drug production. If the data is incomplete or unreasonable, the FDA will reject the review. Otherwise, the FDA will complete the review within about 10 months and give an approval or rejection opinion.

Ii. FDA Registration Process for Drugs

1. Preparation stage

a. Copy of the enterprise legal person license;

b. Copies of production (hygiene) license and certificate of conformity;

c. Company Profile (Establishment time, technical strength, main products and their performance, asset status).

2. Acceptance of the initial technical review application

Submit the English translation documents of the DMF (Master File of the Drug) and SOP (Standard Operating Procedure) to the agent; According to the opinions of the agent, modify the above-mentioned documents.

3. Review of DMF materials

The FDA carefully reviews and conducts on-site inspections at the factory to check whether what is written in the DMF documents is true. If the FDA finds no major errors and deems it to meet the requirements, a pre-approval inspection plan will be proposed.

4. FDA inspection

FDA inspectors inspect the factory, ask questions, and the factory must answer them one by one. If there are any doubts, officials will issue the "483" form (rectification recommendation letter). However, if the problem is serious, the "483" form will not be given.

5. The FDA issues the "approval letter"

The questions raised by the prosecutor on the "483" form must be answered carefully. If there are any problems, they must be corrected immediately