7 Common Questions About IND Application

Inquiry

Submitting an Investigational New Drug (IND) application is an important milestone in the process of new drug development, marking the transition from laboratory research to human clinical trials. Submitting an IND application requires careful planning and strict compliance with regulatory requirements, especially for first-time applicants, which poses significant challenges. Proregulations will address the seven common questions frequently received regarding how to submit an IND application in a timely and structurally sound manner.

1. What is the Structure of the Common Technical Document (CTD)?

The CTD consists of the following five modules:

Module 1: Administrative and prescription information required by local regulatory authorities for the IND application.

Module 2: Summarization and overview of quality, non-clinical data, and clinical data.

Module 3: Information related to the quality of drug raw materials and drug preparations, including manufacturing process information.

Module 4: Non-clinical research reports, including toxicology, pharmacology, and pharmacokinetic evaluations. Some studies require the provision of the complete dataset in the Standard for Exchange of Nonclinical Data (SEND).

Module 5: Clinical research data, including completed clinical research reports, study protocols, 1572 forms, resumes of researchers, and supporting clinical publications.

Submission method

The FDA requires sponsors (except academic institutions) to provide the IND application in eCTD format through the Electronic Submission Gateway (ESG).

2. What Are the Purposes and Values of the Pre-IND Meeting?

The sponsor can apply for a Pre-IND meeting before submitting the IND application to obtain FDA's feedback on the proposed development strategy, thereby minimizing the possibility of clinical trial suspension.

Timing of the Pre-IND Meeting

(1) The timing of the meeting will vary depending on the development plan. Generally, the sponsor needs to arrange this meeting 3 to 9 months before submitting the IND application.

(2) The FDA usually responds within 21 days after receiving the request for the Pre-IND meeting and arranges the meeting within 60 days.

(3) The sponsor needs to submit a briefing document 30 days before the meeting, listing their specific questions. In some cases, the FDA may also provide a written response instead of holding a meeting.

During the Pre-IND meeting, the sponsor may request the FDA to provide feedback on the following topics:

Potential issues with the drug raw materials, drug formulations or recipes to be used in humans
Acceptability of the clinical trial design
The sufficiency of preclinical studies, including toxicological studies
Potential pharmacokinetic issues and dose limitations
Clinical safety monitoring-related issues

(4) After the meeting, the FDA will provide any final opinions within 30 days.

3. Can Overseas Data be Included in the IND Application?

Usually, if overseas research meets the following requirements of GCP, the FDA will accept it to support the IND or marketing application.

Qualified researchers
Independent ethics committee review
Appropriate monitoring
Appropriate informed consent
Use of appropriate drug products

These overseas research data must be considered applicable to the American population and American medical practice. For example, overseas research uses companion diagnostics or comparison drugs, and these drugs need to obtain the same approval for their use in the United States. In addition, the sponsor should ensure that the FDA can verify the effectiveness of overseas research through on-site inspections (if necessary).

4. Which FDA Center Reviews Applications for Combined Products?

The review and regulation of combination products will be assigned to the appropriate FDA center based on the product's Primary Mode of Action (PMOA) - defined as the single mode of action that provides the most significant therapeutic effect.

Drug-based combination products: Such as metered-dose inhalers or auto-injectors, are primarily reviewed by CDER.

Biological products-based combination products: CBER is responsible for the review.

Medical device-based combination products: CDRH is responsible for the review.

5. What Are the Manufacturing Requirements in IND?

The FDA adopts a phased approach to GMP. For the first stage of research, the FDA's review focuses on CMC information to ensure the safety of the products used by the participants in the proposed clinical trial.

Specific requirements include:

Clear written procedures, methods and norms
Fully controlled equipment and production conditions
Accurate and consistent data from the production process, including analytical methods, release tests and stability tests
For injectable products, proof of compatibility with intravenous infusion bags and tubes is required
Proof of consistent stability of the drug during the trial

6. How Long is the Regulatory Period for IND Submissions?

Planning Phase

Day 0: Initiate a meeting to identify all module elements and generate a schedule/tracking tool.
Day 30: Define plan for regulatory interactions and conduct Pre-IND meeting.

Execution Phase

Day 45: Begin IND development, build Modules 1-5, and conduct rolling release and regulatory review of modules.
6 to 9 months: Conduct IND submissions.

Maintenance Phase

IND Submission: Maintenance of the IND begins after the IND is submitted
30 days after IND Submission: The FDA will complete the review within 30 days and issue either an IND submission or an IND submission. The FDA will complete the review within 30 days and issue either a notice that the research can continue or a letter requesting a clinical pause.

In order to streamline the submission process, sponsors should take a structured and systematic approach to documenting their discoveries and development work from day one.

We recommend that sponsors start with the end goal in mind (IND submission) and document the milestones required for each application as they are completed, rather than trying to prepare all the necessary documents at once during IND development.

7. Are There Ways to Expedite Regulatory Review or Approval?

FDA currently offers five pathways to expedite drug development:

Orphan designation
Fast track
Breakthrough therapy
Priority review
Accelerated approval

Our Services

Proregulations specializes in providing comprehensive IND application support services to our clients, aiming to ensure that every step of the new drug research and development process complies with the strict requirements of the FDA, thereby increasing the success rate of IND applications and accelerating product launch.

Regulatory interpretation and consultation
Regulatory training
IND application strategy planning
Qualification assessment of accelerated approval routes
Pre-IND meeting preparation and application
CTD document writing, pre-review and submission
eCTD format review
FDA agent

Proregulations has rich experience in IND application and project management, dedicated to simplifying the IND application process for customers and accelerating the process of new drugs from the laboratory to the market. If you are interested in our services, please contact us.