The drug FDA certification

FDA on pharmaceutical products have a complete set of authentication procedures in order to ensure that the drug is safe and effective. The procedures are as follows:
In 1, an investigational new drug ( IND ) trial please:
When the pharmaceutical company submitted to FDA IND, FDA drug monitoring started. This drug in human experiment has yet to begin, FDA main audit in vitro safety data with data from animal experiments, to determine the drug is safe enough to enter the body of experimental stage.
In 2 experiments: experiment of human body is divided into 4 phases: a period to test the safety of the drug, the main side effects, metabolic mechanism, such as number of samples, generally less than 200 two main test drug effectiveness, to determine whether drugs can effectively act on the human body. At the same time, drug safety and toxicity effects are also observed close to the object. Two experimental samples were generally less than 300 if the phase two trials are encouraging, more samples will be preparing test, experiment into the three phase. Phase three will include different age, different populations, with different amount of medication, to the comprehensive study of drug safety and the validity. Three sample number in the hundreds to thousands of dollars. Four stage mainly in new drug approval, the main test drugs for the long-term safety, new populations.
3 new drug application ( NDA ): when the pharmaceutical company completed a human experiment, verified the effectiveness and safety of new drugs, formally submitted to FDA NDA for . FDA audit all animal and human experimental data, and the generation of drug solution mechanism of drug production data, GMP data, if the data is not complete or unreasonable, FDA will refuse to Shen Li, otherwise FDA will in about 10 months after the Shanghai nucleus, giving consent or refusal of opinion.
The above content." MTG FDA certification service center service manual.".