1.Registration Strategy Planning: Select the appropriate pathway (NDA/BLA/ANDA) based on product type (chemical drug/biological product/generic drug);

2.Document Preparation & Review: Assist in preparing CTD modules (non-clinical, clinical, CMC) to ensure compliance with eCTD format requirements;

3.FDA Communication: Organize Pre-NDA/BLA meetings and address IR (Information Request) and CRL (Complete Response Letter);

4.Regulatory Compliance: Ensure adherence to GDUFA/PDUFA fee requirements and annual maintenance obligations.

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1.Definition and Background

NDA (New Drug Application)

NDA is the core procedure for innovative drugs (including new chemical entities, new dosage forms, new indications, etc.) to apply for marketing approval from the FDA. It requires complete non-clinical (pharmacology/toxicology) and clinical data to demonstrate the drug's safety and efficacy. NDA applies to drugs seeking first-time marketing approval in the U.S., with its evaluation based on the "risk-benefit balance" principle.

BLA (Biologic License Application)

BLA applies to biological products (e.g., vaccines, blood products, gene therapies). According to the Biologics Price Competition and Innovation Act (BPCIA), biological products must be approved through the BLA pathway. Its data requirements are similar to NDA but require additional focus on manufacturing process and biological characteristics consistency.

ANDA (Abbreviated New Drug Application)

ANDA is specifically designed for generic drugs. Applicants are not required to repeat the innovator drug's preclinical and clinical studies but only need to demonstrate bioequivalence to the Reference Listed Drug (RLD). ANDA approval is based on the RLD information in the "Orange Book," aiming to reduce development costs and accelerate generic drug market entry.

2.Applicable Registration Scope

NDA:

·New dosage forms, new indications, new fixed-dose combinations, etc.

·Requires clinical trials to prove safety and efficacy

BLA:

·Biological products (e.g., monoclonal antibodies, recombinant proteins, cell therapies)

·Must comply with FDA's special regulatory requirements for biological products, including manufacturing process validation and stability studies

ANDA:

·Generic drugs must be consistent with the RLD in active ingredients, dosage forms, strengths, and indications

·Only bioequivalence data is required (preclinical and clinical studies are exempted)

3.Basic Registration Requirements

·The submission materials must ultimately be converted into eCTD format, presented as PDFs in eCTD, and submitted via ESG.

·Applicants can be non-U.S. registered companies but must have a U.S.-based contact as a U.S. Agent and provide the U.S. Agent's authorization letter in Module 1.

·The package insert must be prepared in SPL format.

·The application materials should include a comprehensive list of all referenced or involved clinical trial sites and manufacturing sites.

NDA/BLA:

·Non-clinical data: Must comply with ICH guidelines, including pharmacology, toxicology, and pharmacokinetic studies

·Clinical data: Must provide Phase I-III clinical trial results to prove safety and efficacy

·Quality data: Includes CMC (Chemistry, Manufacturing, and Controls) information for both drug substance and drug product

ANDA:

·Required documents: Only M1, M2 (only sections 2.3 and 2.7), M3, and M5

·Bioequivalence studies: Must demonstrate equivalence to the reference drug through in vivo or in vitro studies

·CMC data: Must comply with 21 CFR requirements to ensure manufacturing process and quality control

·Labeling consistency: Indications and dosing must be consistent with the RLD

4.Registration Process

NDA/BLA Process:

1)Pre-application preparations: Apply for DUNS number, facility FEI number, establish ESG account, designate U.S. Agent, apply for NDA/BLA number, conduct 2) Pre-NDA/BLA meeting, confirm distributor information and NDC number (if applicable), and apply for proprietary name.

2)Preparation of submission materials: Sequence number, main content (CTD), format.

3)Submission of materials: Before submission, confirm if there are any refuse-to-file items per relevant guidelines, confirm payment status, and submit materials.

4)Review timeline:

Standard review timeline and priority review timeline are 10 months and 6 months, respectively, calculated from the submission date.

ANDA Process:

1)Pre-application preparations: Apply for DUNS number, facility FEI number, establish ESG account, designate U.S. Agent, apply for ANDA number, and confirm distributor information and NDC number.

2)Preparation of submission materials: Sequence number, main content (CTD), format.

3)Submission of materials: Before submission, confirm if there are any refuse-to-file items per relevant guidelines, confirm payment status, and submit materials.

4)Review timeline:

According to GDUFA III, 90% of original ANDA standard review timelines are 10 months from the submission date; 90% of original ANDA priority review timelines are 8 months (if conditions are met); if restricted, 90% of original ANDA priority review timelines are 10 months from the submission date.

5.Regulatory Basis

FD&C Act:

·Section 505(b)(1) governs NDA, Section 505(j) governs ANDA

·Section 351 (PHS Act) governs BLA

21 CFR:

·NDA (21 CFR 314), ANDA (21 CFR 314.94), BLA (21 CFR 601)

·GMP (21 CFR 210/211), GLP (21 CFR 58), etc.

Industry Guidelines:

·FDA-issued "NDA Content and Format Guidance," "Bioequivalence Study Guidance," etc.

·ICH technical guidelines (e.g., CTD format).