Regulatory submissions in the pharmaceutical industry are categorised by development stage, product type, and regulatory authority, including INDs, NDAs, ANDAs, DMFs, and the CTD/eCTD format. The development of a pharmaceutical product, from the lab bench to the pharmacy shelf, is a long, complex, and highly regulated process. To ensure safety, efficacy, and quality, pharmaceutical companies […]
Regulatory submissions in the pharmaceutical industry are categorised by development stage, product type, and regulatory authority, including INDs, NDAs, ANDAs, DMFs, and the CTD/eCTD format.
The development of a pharmaceutical product, from the lab bench to the pharmacy shelf, is a long, complex, and highly regulated process. To ensure safety, efficacy, and quality, pharmaceutical companies must navigate through a series of regulatory submissions across the drug development lifecycle. These submissions not only provide the necessary data for approval but also establish compliance with global regulatory standards.
In this article,I will discuss the major types of regulatory submissions—IND, NDA, ANDA, DMF—and how they are compiled using standardised formats like the CTD/eCTD.
The following are the major classifications of Regulatory Submissions:
When it’s used: Preclinical to early clinical development.
An IND application is the first regulatory milestone in the drug development process. It is submitted to regulatory authorities (such as the FDA in the U.S.) before a new drug can be tested in humans.
Approval of an IND enables the sponsor to begin Phase I clinical trials.
When it’s used: Post-clinical trials, to seek marketing approval.
An NDA is submitted after all three phases of clinical trials are completed. It presents comprehensive data on the drug’s safety, efficacy, pharmacology, and manufacturing.
If the regulatory authority finds the benefit-risk profile acceptable, market authorisation is granted.
When it’s used: For generic drugs.
An ANDA is submitted to obtain approval to market a generic version of an already approved brand-name drug.
Generic drugs must meet the same quality standards as branded drugs.
When it’s used: To provide confidential manufacturing and quality information.
A DMF is a submission to the regulatory authority that contains detailed information about:
DMFs are typically referenced in NDAs, ANDAs, or other submissions, allowing third parties (e.g., API manufacturers) to protect proprietary information while supporting a sponsor’s regulatory filing.
To harmonise the drug approval process globally, regulatory submissions are now organised using the Common Technical Document (CTD) format, developed by the International Council for Harmonisation (ICH).
The electronic Common Technical Document (eCTD) is the digital version of CTD, allowing for easier submission, review, and tracking by regulatory agencies.
Each stage of drug development—from discovery to commercialisation—requires a well-defined regulatory submission tailored to the product and its development status. Understanding the purpose and content of INDs, NDAs, ANDAs, and DMFs, and presenting them in the standardised CTD/eCTD format, is essential for a successful regulatory strategy.
In an era of global drug development and digital transformation, mastering regulatory submissions is not just a compliance necessity—it’s a competitive advantage.
The regulatory submission process is a systematically organised sequence of steps for submitting comprehensive documentation to regulatory authorities, aiming to obtain product approval within the pharmaceutical industry. It requires meticulous planning, thorough preparation of documentation, and effective communication with authorities to ensure compliance with regulatory standards and to demonstrate the safety and efficacy of the product.
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