Bla (Biological Product License Application) is the abbreviation of Biologic License Application, which is a document submitted to the FDA of the United States to support the review and final approval of the listing and sale of biological products in the United States.
The application for listing of biological products was approved in accordance with the relevant provisions of the Public Health and Medical Services Law. The bill requires companies that produce biological products to hold relevant product licenses when selling products across States.
BLA refers to a submission containing specific information about the production process, chemistry, pharmacology, clinical pharmacology and medical effects of biological products. If the materials provided meet the requirements of the US Food and Drug Administration, the application will be approved and the manufacturer will be granted a license to market the relevant products.
New drug application (NDA)
New drug application, when the applicant has sufficient reasons to prove that the safety and effectiveness of the drug meet the FDA's marketing requirements, the applicant can submit NDA to the FDA. All new drugs must go through the new drug evaluation process before they can be listed in the United States. The submitted materials must include chemical, pharmacological, biological agents, statistics and other technical data for review. ?
If NDA is approved, the drug can be marketed in the United States. In addition, for internal tracking, all NDA applications will have an NDA number. Generally, NDA audit and IND audit are conducted by the same audit team, but NDA will undoubtedly be more time-consuming. ?
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.