REGULATORY DOCUMENTS IN PHARMACEUTICAL INDUSTRY

REGULATORY DOCUMENTS IN PHARMACEUTICAL INDUSTRY

Investigational New Drug Application (IND)

It is an application from a clinical research sponsor to the Food and Drug Administration (FDA) for authorization for administering an investigational drug to humans.

INDs are classified into three types:

An investigator IND is submitted by a physician who begins and investigates the clinical trial drug and manages its administration or dispensing.
Emergency Use IND allows the FDA to authorize the use of an investigational drug in an emergency situation that does not allow for the submission of an IND in compliance with 21 CFR.
Treatment INDs are submitted for investigational drugs that show promise in clinical testing for serious life-threatening illnesses.

Types of Investigational New Drug Application

IND applications must include information in three broad areas:

Animal Pharmacology and Toxicology Studies
Manufacturing Information
Clinical Protocols and Investigator Information

Wat is investigational new drug application

Three Important Componates of IND

Once the IND is submitted, the sponsor must wait 30 days before beginning any clinical trials. The FDA examines the IND for safety to ensure that research subjects are not exposed to an unwanted risk.

New Drug Application (NDA)

The NDA application formally proposes the FDA approve a novel drug for sale and marketing in the United States. The NDA contains the data collected during an Investigational New Drug (IND)'s animal research and human clinical trials.

The NDA's objectives are to give the FDA reviewer enough details to enable them to make the following major decisions.

Whether the medicine is safe and effective in its intended use(s), and whether the benefits go over its risks.
Determine whether the drug's proposed labelling meets your needs and what it should include.
Whether the drug's manufacturing processes and quality control measures are sufficient to maintain the drug's identity, strength, quality, and purity.

NDA Review Process

Biologics License Applications (BLA)

The Biologics License Application (BLA) is an application to sell or transport a biologic product into the United States.

A BLA is submitted by any legal person or company engaged in manufacturing or by a license holder who accepts ownership of products and sets up standard compliance.

The BLA contains the following:

Applicant information
Product/Manufacturing information
Pre-clinical studies
Clinical studies
Labeling

Componates of BLA

Abbreviated New Drug Application (ANDA)

An abbreviated new drug application (ANDA) was filed with the FDA for testing and potential approval of a generic medicine product. If accepted, a company can manufacture and market the generic drug product as a safe, effective, and less costly alternative to the brand-name drug it references.

A generic medicine product is one that is like an innovator drug product in terms of dosage form, strength, method of treatment, quality, performance properties, and intended application.

what is abbreviated new drug application

Generic Medicine VS Innovator Drug

Generic drug applications are known as "abbreviated" as they don't usually need to include both preclinical (animal) and clinical (human) evidence to show safety and efficacy.

Subsequent New Drug Application (SNDA)

It is also known as the Supplemental New Drug Application.

SNDA application sent to the United States Food and Drug Administration (FDA) seeking approval of a previously approved and marketed new medicine. This form is for requesting changes to an existing medicine, such as a new indication, dose regimen, or formulation.

The goal of a Subsequent New Drug Application (SNDA) is to demonstrate that a new medicine is safe and effective for its intended use. When a medicine is already approved for single use and the company wishes to expand its usage to other indications, the FDA demands an SNDA.

Supplemental New Drug Application (sNDA) | Subsequent New Drug Application

Common Technical Document (CTD)

The document compiles all Quality, Safety, and Efficacy information in a common format known as CTD - Common Technical Document. It has transformed regulatory review processes, resulting in harmonized electronic submissions and the introduction of best review practices.

The CTD is divided into five modules. Module 1 is region-specific, while Modules 2, 3, 4, and 5 are designed to be universal to all regions. In the EU, Japan, and the United States, new drug applications must be submitted in the CTD format.

5 Modules of CTD

Module 1: Gives administrative and prescription information.

Module 2: Summaries of common technical documents.

Highlights the information to be included in the dossier's quality (Module 3), nonclinical (Module 4), and clinical (Module 5).

Module 3: Quality

Defines the format and organization of the chemical, pharmaceutical, and biological data required for the application.

Module 4: Safety (nonclinical study reports)

Defines the format and organization of nonclinical (pharmaco-toxicological) data important to the application.

Module 5: Efficacy (clinical study reports)

Explains the structure and organization of the clinical data required for the application.

Electronic Common Technical Document (eCTD)

The eCTD is the standard format for filing applications, changes, supplements, and reports to the FDA.

Electronic submission criteria will be optional but recommended in the following categories:

Noncommercial INDs
Submissions for blood and its components, including source plasma
Submissions of Type III Master Files

CONCLUSION

Regulatory documents ensure that medicines are safe, effective, and of high quality throughout their development and approval processes. These frameworks, that go from IND to NDA, along with formats such as CTD and eCTD, speed up the procedure while maintaining compliance and timely access to safe medicines.

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