Preparation and Submission of Regulatory Documents

The journey from drug development to market approval is both lengthy and challenging. During this process, the Sponsor must submit accumulated drug development data to regulatory agencies in a timely, accurate, and compliant manner. Effective communication between the Sponsor and regulatory agencies, the achievement of milestones, and ultimately, the outcome of regulatory evaluations are of paramount importance. Here are some important registration application milestones:

IND Application

The Investigational New Drug (IND) application marks the first milestone in the clinical development of a new drug. Before being used in human clinical trials, the Sponsor must provide the FDA with a series of drug data, including CMC, non-clinical, and clinical information. The FDA's review division conducts a comprehensive evaluation of the IND application in various disciplines within the subsequent 30 days to ensure the product's suitability for clinical trials. During the IND review process, the FDA may request additional information (an information request) from the applicant. Timely responses addressing the FDA's concerns and supplying necessary information are essential. Failure to meet the FDA's requirements within 30 days may result in the IND application being placed on clinical hold; conversely, the applicant can proceed with clinical trials (study may proceed) if all requirements are met.

NDA/BLA/ANDA and Post-Marketing Changes

To market a new drug in the United States, the Sponsor must formally submit a New Drug Application (NDA) or Biologics License Application (BLA) to the FDA. There are three pathways under Section 505 of the Food, Drug, and Cosmetic (FD&C) Act for new drug approval: 505(b)(1) NDA [New Molecule], 505(b)(2) NDA [New Molecule or Improved New Drug], and 505(j) ANDA [Generic Drug]. BLA, governed by both the FD&C Act and the Public Health Service (PHS) Act under Section 351, applies to biologics and includes two pathways: 351(a) BLA [New Biological Product] and 351(k) BLA [Biosimilar].

IND Maintenance

After obtaining clinical approval until the submission of the marketing application, the Sponsor needs to maintain the IND in accordance with FDA regulations. IND maintenance tasks primarily include annual reports, safety reports, protocol amendments, information amendments, and correspondence with the FDA.

FDA Meeting Briefing

Meetings serve as the primary channel for formal communication between the Sponsor and the FDA. Through these meetings, the Sponsor can gain early insights into the FDA's stance and opinions on specific issues, guiding product development and mitigating potential risks. To conduct effective meetings with the FDA, the Sponsor needs to carefully prepare meeting questions and background materials to support the discussions, known as briefing packages.

DMF Filing

Drug Master Files (DMFs) are submissions to the FDA containing detailed, confidential information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products. DMFs allow parties to reference materials without revealing the content of the DMF. DMF filing is not a statutory or regulatory requirement, and filing does not imply approval or rejection. When reviewing applications that reference DMFs (e.g., NDA, ANDA, IND, and BLA), the FDA evaluates the technical content of the DMFs.

NMPA Drug Registration

The regulatory oversight for drug market approval in China is similar to that in the United States. Different types of drugs mainly include investigational new drug applications (IND), new drug applications (NDA), generic drug applications, consistency evaluation, post-marketing changes, and re-registration applications.

What Can Humphries Do

Over the past decade, Humphries's team has successfully assisted clients in obtaining approval for over 100 IND, NDA, BLA, and ANDA applications. We have extensive experience with a wide range of products, including small-molecule drugs, antibodies and proteins, peptide drugs, nucleic acid drugs, cell and gene therapy products, live microorganism products, herbal medicines, and more. Leveraging our practical experience and efficient teamwork, Humphries can provide personalized regulatory registration solutions for various products and clients, including but not limited to the following services:

01. Meeting Document Preparation

Humphries can assist you in preparing high-quality meeting materials to better achieve the meeting's objectives. For detailed information, please seeRegulatory Agency Meetings and Communications.

02. IND Application Document Preparation

Humphries's regulatory and technical teams can review or prepare a complete set of IND submission materials and assist you in responding to regulatory agency meetings or reviewing comments.

03. Maintenance and Change Work

Humphries has established a systematic IND maintenance workflow. We are familiar with different types of maintenance work deadlines, document requirements, and review priorities, ensuring that you complete IND maintenance work on time and in compliance.

04. Marketing Application Work

Humphries's consultants have extensive experience in NDA/BLA review and submission. We can participate in the entire process of a new drug marketing application, including formulating submission strategies and plans, writing and reviewing materials from various disciplines,attending regulatory agency meetings and communications, and responding to regulatory agency comments, until milestones are achieved.

05. Project Management Work

Humphries has an experienced project management team (see Regulatory Project Management) that can efficiently coordinate your internal team. Humphries's eCTD team (see eCTD Compilation and Submission) can smoothly connect the preparation process of submission materials, ensuring that the submission goals are achieved on time and with high quality.