Abbreviative New Drug Application, abbreviated ANDA. According to the US Food, Drug and Cosmetic Act (FDCA) and the US Federal Administration Act 21 CFR Part 21, generic drugs after the patent period are applied for marketing according to this procedure.

However, the Drug Price Competition and Patent Life Restoration Act (Waxman-Hatch Act) does not apply to biologics, which cannot be approved for marketing under an ANDA. There has been a lot of lobbying for biologics, but no law.

The ANDA registration in the United States is equivalent to the generic drug registration in China, which is simpler than the registration of new drugs. According to the actual situation in China, generic drug registration in the United States, that is, ANDA application, is suitable for large and medium-sized pharmaceutical manufacturers in China. India is far ahead of China in this regard, and about 30% of ANDA applications are currently filed by Indian manufacturers.

Applicants for ANDA are not required to be companies (legal persons), foreign applicants can submit ANDA applications to FDA through U.S. agents, and maintain contact with FDA to handle relevant registration matters.

The Drug to be applied for ANDA by FDA should be a drug that has been approved for marketing by FDA and is Listed as a Reference Listed Drug in the "Drug Approved by Therapeutic Equivalence Evaluation (Orange Book)". If an applicant intends to copy a drug that is listed in the Orange Book but does not have a reference preparation, he or she must first file a Citizen Petition requesting FDA to designate the drug as a reference preparation. The drug to be applied for ANDA must have the same active ingredient, dosage form, specification, route of administration, and indication as the reference drug. If the drug to be applied for ANDA has the same conditions as the reference drug, the relevant Citizen Petition must be submitted first and FDA approval can be obtained before the ANDA application can be submitted. The drug product to be applied for an ANDA must be bioequivalent to the reference product. Drugs to be applied for ANDA must comply with drug manufacturing practices in accordance with 21 CFR of the United States Federal Regulatory Act to control the manufacturing process.

1. Registration type: Drugs eligible for ANDA

2, registration data requirements: ANDA registration data must be submitted in e-CTD format, can be submitted through the FDA's Electronic Submission Gateway (ESG), for more than 10GB of registration data, can be submitted on physical media, such as CD-ROM.