The FDA new drug review process includes two processes: ind filing for new drug clinical trial application and new drug application NDA application. After the applicant completes the preclinical study of the new drug, he can submit an IND filing to the FDA. If the FDA does not object within 30 days of receipt Applicants can conduct clinical research on new drugs by themselves. Generic drug applications are usually considered short, because such applications do not need to provide preclinical animal and clinical human data to prove their safety and effectiveness. Let’s take a look at what are IND, NDA and ANDA declarations?
The main purpose of the IND is to provide sufficient information to prove that the drug is safe to be tested in humans and to prove that the design of the clinical program for research purposes is reasonable. The IND mainly includes phase I, II, and III clinical trial applications. The phase I and II clinical trials are the initial clinical trials, which are the exploratory stage of efficacy; the phase III clinical trials are the expanded clinical trials, which are the verification stage of the efficacy. After the clinical trial IND is approved, applicants can submit an application for expanded clinical trial.
Medicilon’s clinical registration (IND) application service platform has an in-depth understanding of the regulatory and policy environment of China and the United States and its technical requirements for chemical drugs. It can provide domestic customers with CFDA IND application and USFDA IND/ANDA application services; it can provide foreign customers Provide CFDA IND/ANDA declaration service. The service targets of Medicilon’s clinical registration application platform include not only customers who do a complete set of preclinical research on Medicilon, but also pharmaceutical industry counterparts who have separate clinical registration requirements.
In the IND application stage, the FDA generally stipulates (minimum) that drug sponsors must: (1) do pharmacological studies of the drug; (2) conduct acute toxicity tests on at least two species of animals; (3) follow the intended use of the drug Conduct a short-term study of two weeks to three months. Once the pre-clinical research is over, the animal test is not over and then completed. Many longer and more specialized studies such as chronic and anti-cancer tests will be carried out throughout the new drug application process.
Preclinical studies are used to evaluate: (1) the pharmacological phenomena and mechanism of action (MOA) of the drug; (2) the toxicity characteristics and target organs of the drug; (3) the absorption, distribution, metabolism and excretion of the drug (ADME). When the drug sponsor believes that it has sufficient data to prove that the drug is safe, it can prepare to submit a new drug clinical investigation application (IND) to the FDA. In essence, the IND is just a suggestion. Through this suggestion, the drug sponsor obtains the permission of the FDA to start testing on humans.
When the third phase of human trials is completed and the required non-clinical trials have ended, a set of information can be issued to apply to FNS for approval of the new drug marketing authorization. The main purpose of NDA is to ensure the safety, effectiveness and quality control of the listed drugs. Taking the botanical NDA as an example, the FDA believes that in addition to its quality standards and chemical drugs, they should meet the same marketing standards in terms of safety and effectiveness. Therefore, the FND’s approval requirements for the safety and effectiveness of botanical NDA are the same as those of chemicals with the same indication, but the quality standards may be different.
The NDA application materials for botanical drugs are similar to chemical drugs, mainly including the following: CMC data, non-clinical pharmacology and toxicology data, human pharmacokinetics and bioavailability data, microbial data, clinical data, safety data update reports, statistics Academic data, case report forms, relevant patent status, samples, packaging and labels, etc.
Generally, NDA applications can be submitted to the FDA if the following conditions are met:
(1) New molecular entity (NME);
(2) New chemical entity (NCE);
(3) New base and new ester base of the same chemical composition of the originally approved drug;
(4) The composition of the new formula of the originally approved drug;
(5) New indications of the originally approved drugs (including the conversion of prescription drugs to over-the-counter drugs);
(6) New dosage forms, new routes of administration, new specifications (unit content);
(7) A new combination of two or more originally approved drugs.
An ANDA application is to “copy” a product that has been approved for marketing. Among them, “replication” here means that it has the same active ingredients, dosage forms, specifications, modes of administration, and indications as the marketed drug. Generic drug applications are called abbreviated because they do not require preclinical (animal) and clinical (human) data to prove their safety and effectiveness. Instead, applicants for generic drugs must provide proof of product bioequivalence (for example, there is no difference compared with the original drug). Once such drugs are approved, applicants can produce and market this safe, effective and inexpensive alternative.
The BE test is to compare the in vivo absorption and absorption rate of generic drugs and original drugs. Therefore, the provision of data derived from the BE test is a key component of the ANDA application materials. Together with the assessment of pharmaceutical equivalence, the establishment of bioequivalence allows the conclusion of therapeutic equivalence at the level of pharmaceutical regulatory supervision.
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