On May, 2020 1 1, the company received the Notice of Acceptance of the New Drug Listing Application (NDA) of Donafenib Toluene Sulfonate Tablets issued by the State Administration of Pharmaceutical Products (NMPA). For details, please refer to the Announcement on Obtaining the Acceptance Notice of New Drug Listing Application disclosed by the company on May 12, 2002.
Extended data:
When the third phase of human trials is completed and the required non-clinical trials have ended, a set of information for approving the marketing license of new drugs can be released to FNS. The main purpose of NDA is to ensure the safety, effectiveness and quality control of listed drugs. Taking NDA as an example, FDA believes that besides being different from chemical drugs in quality standards, it should also meet the same listing standards in safety and effectiveness. Therefore, FND's approval requirements for NDA are the same as those for chemicals with the same indications, but the quality standards may be different.
The NDA application materials of botanical drugs are similar to those of chemical drugs, which mainly include the following contents: CMC data, non-clinical pharmacological and toxicological data, human pharmacokinetics and bioavailability data, microbial data, clinical data, safety data update reports, statistical data, case report forms, related patents, samples, packaging and labels, etc.
Generally, NDA can be applied to FDA if the following conditions are met: (1) New Molecular Entity (NME);
(2) New chemical entity (NCE);
(3) New bases and new ester groups with the same chemical composition as the original approved drug;
(4) the ingredients of the original approved new drug formula;
(5) the new indications of the original approved drugs (including the use of prescription drugs to over-the-counter drugs);
(6) new dosage forms, new routes of administration and new specifications (unit content);
(7) New combinations of two or more drugs originally approved.
Three. ANDA declaration
ANDA's application is to "copy" a product that has been approved for marketing. Among them, "imitation" here refers to having the same active ingredients, dosage forms, specifications, ways of taking and indications as listed drugs. Generic drug applications are called abbreviations because they do not need to provide preclinical (animal) and clinical (human) data to prove their safety and effectiveness. Instead, the applicant for generic drugs must provide proof of bioequivalence of the product (for example, there is no difference compared with the original drug). Once the drug is approved, the applicant can produce and sell this safe, effective and low-cost substitute.
BE test is to compare the absorption degree and absorption rate of generic drugs and original drugs, so providing the data of BE test is the key part of ANDA application materials. Together with the evaluation of drug equivalence, the establishment of bioequivalence allows the conclusion of therapeutic equivalence at the level of drug supervision.