Regulatory Considerations for IND Applications
The path to getting a drug to the clinic is not always straightforward and is often filled with speed bumps and obstacles. However, this journey can be made much easier with the proper guidance. IND submissions governed by regulatory management are very important as drug safety and efficacy depend on the recognition of current Good Manufacturing Practices (GMPs).
We understand the many moving parts of the regulatory application process, and seamless alignment and integration are essential to ensuring a successful IND submission to the appropriate regulatory agency. A successful IND filing is a key milestone in your drug development journey, and it’s important you get it right to accelerate time to market.
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Make IND Regulatory Submission a Success
It is often difficult to find the best practices for IND submission success amid the chaos of preparation, as there are a lot of factors that contribute to successful IND applications. Our regulatory advisory team can help you keep track of the ever-changing regulations in various regions of the world, provide advice on legal requirements, develop a regulatory strategy for your product’s lifecycle, help interface with the relevant regulatory agencies, and assist in the preparation of required registration documents for market approval.
Frequently Asked Questions (FAQs) About IND Submissions and Filing
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What are the names of some of the regulatory agencies?
Every country has its own regulatory authority responsible for enforcing rules and regulations and issuing guidelines for drug development, licensing, registration, manufacturing, marketing, and labeling of pharmaceutical products. Some of the regulatory bodies include:
- United States: Food and Drug Administration (FDA)
- European Union: European Medicines Agency (EMA)
- United Kingdom: The Medicines and Healthcare products Regulatory Agency (MHRA)
- Canada: Health Canada (Health Products and Food Branch)
- PMDA (Japan) – Pharmaceuticals and Medical Devices Agency
- Australia: Therapeutic Goods Administration (TGA)
- Switzerland: Swissmedic
- South Korea: Ministry of Food and Drug Safety (MFDS)
- China: National Medical Products Administration (NMPA)
- India: Central Drugs Standard Control Organization (CDSCO)
- Brazil: National Health Surveillance Agency (ANVISA)
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What is required for IND filing?
Each IND filing application should include the following:
- Form FDA 1571 (IND application cover letter)
- Form FDA 1572 (Investigator’s statement)
- Form FDA 3674 (certification requirement & mandatory registration and reporting of results for applicable clinical trials through ClinicalTrials.gov.)
- Table of Contents
- Introductory Statement
- General Investigational Plan
- Investigator’s brochure
- Protocol(s): study protocol(s), investigator data, facilities data, Institutional Review Board (IRB)
- Chemistry, manufacturing, and control (CMC) data, including environmental assessment or claim for the exclusion (assuming the draft of CMC information exists)
- Nonclinical: pharmacology and toxicology data
- Clinical: previous human experience
- Additional information to support the IND filing
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What are examples of regulations governing nonclinical studies for IND Submissions?
There are several regulations governing nonclinical studies for Investigational New Drug (IND) submissions, including:
1. 21 CFR Part 58 - Good Laboratory Practice for Nonclinical Laboratory Studies: This regulation outlines the requirements for nonclinical laboratory studies, including the design, conduct, and reporting of such studies. It also covers the qualifications of personnel, the facilities, and the equipment used in nonclinical studies.
2. 21 CFR Part 312 - Investigational New Drug Application: This regulation outlines the requirements for IND submissions, including the information that must be included in an IND application, such as the results of nonclinical studies and the proposed clinical plan for the investigational drug.
3. International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines: The ICH has developed guidelines that provide guidance on the conduct of nonclinical studies and the information that should be included in an IND submission. These guidelines include:
- ICH S6: Preclinical Safety Evaluation of Biotechnology-derived Pharmaceuticals
- ICH S7A: Safety Pharmacology Studies for Human Pharmaceuticals
- ICH S7B: Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals
- ICH S8: Nonclinical Evaluation of the Potential for Phototoxicity of Human Pharmaceuticals
4. FDA guidance documents: The FDA has also developed guidance documents that provide additional information on the conduct of nonclinical studies and the information that should be included in an IND submission. These guidance documents include:
- Guidance for Industry: Preclinical Safety Evaluation of Biotechnology-derived Pharmaceuticals
- Guidance for Industry: Safety Pharmacology Studies for Human Pharmaceuticals
- Guidance for Industry: Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals
- Guidance for Industry: Nonclinical Evaluation of the Potential for Phototoxicity of Human Pharmaceuticals
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How long does an IND submission take?
Depending on the complexity of the project and the partner you choose it can take up to 18 months of preparation before starting your IND program. In light of this, it is in your best interest to get started on preparations as early as possible. Once the IND is filed, the sponsor must wait 30 calendar days before initiating any clinical trials. During this time, FDA has an opportunity to review the IND for safety to assure that research subjects will not be subjected to unreasonable risk.