1. Feasibility Analysis: Evaluate the compliance and risks of product registration under US IND/NDA pathways.

2. Gap Analysis of Documentation: Pre-review CMC, toxicology, and clinical protocols to provide optimization recommendations.

3. Pre-IND Meeting Support: Prepare meeting materials, conduct Q&A simulations, and follow up on FDA feedback.

4. Dossier Preparation & Submission: Author, translate, and submit regulatory documents in full compliance with CTD format requirements.

5. IND Maintenance: Handle clinical protocol amendments, information updates, safety reports, and annual reports.

6. Orphan Drug Designation (ODD) Application: Prepare and submit applications for orphan drug status.

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1. Definition and Background

Investigational New Drug (IND): Refers to new drugs that have not yet received marketing approval and are undergoing various stages of clinical investigation.

Prior to IND submission, applicants may request a Pre-IND meeting to seek FDA guidance on multidisciplinary issues. The Pre-IND meeting is not mandatory, and the decision to meet with FDA rests solely with the applicant.

2. Applicable Registration Scope

·New indications, dosage forms, routes of administration, or patient populations for approved drugs

·New combination therapies involving two or more drugs

·New formulations or salt/ester base modifications of originator drugs

·Off-label uses beyond bioequivalence studies (subject to risk assessment)

3. Basic Registration Requirements

·CMC Information: Chemistry, Manufacturing, and Controls data for both drug substance and product, including manufacturing process, stability, and quality standards

·Clinical Protocol: Detailed study design, subject protection measures, and safety monitoring

·Forms: Must include FDA Form 1571 (Application Form) and Form 3674 (Certification of Compliance with Clinical Trials)

4. Registration Process

1) Pre-IND Meeting (Optional but Recommended):

·Submit meeting request (including question list and background materials);

·FDA determines within 21 days whether to hold the meeting;

·Aims to optimize study design and reduce clinical hold risks.

2)IND Submission:

·Prepare complete IND package (Modules 1-5 covering CMC, toxicology, clinical protocol, etc.)

·Submit via electronic portals (e.g., ESG - Electronic Submissions Gateway)

3)FDA Review (30-Day Period):

·FDA evaluates safety data; if no objections, clinical trials may proceed

·If safety deficiencies exist, FDA may issue a "Clinical Hold" requiring supplemental data

4)Ongoing Maintenance:

Submit periodic safety reports, protocol amendments, and annual reports to maintain "active" IND status

5. Regulatory Basis

·Federal Food, Drug, and Cosmetic Act (FD&C Act): Establishes regulatory framework for new drugs;

·21 CFR 312: Specifies IND content, format, and review procedures;

FDA Guidance Documents:

·Content and Format of INDs for Phase 1 Studies

·IND Meetings for Human Drugs and Biologics

·ICH Guidelines: International technical requirements (e.g., Q-Series quality standards)