FDA submissions – FDA Guidelines and catalogue

By Harry   09/20/2021

  Category: Other Blogs

Whenever a new molecule or a generic drug has to be sold in the market, it first needs to be registered with the regulatory agency. Further, when we submit the documentation part for the investigational new drug or new drug application or generic drug, it must be submitted in a particular format. There are set guidelines established by the different agencies and protocols whereby the documents must be submitted. This is known as Dossier. If we discuss it more, it has 5 modules.

In earlier days, those documents were submitted in a hard copy manner. The internet system was not so advanced; hence online submissions were not there. But with the advancement of technology, the dossiers had started being submitted online through the regulatory agency’s portal. When the dossier was earlier submitted offline, it was submitted in the CTD format, also known as Common Technical Document format.

With the advancement of technology, the CTD is now converted into the ECTD (Electronic Common Technical Document). This ECTD is submitted to the regulatory agencies or the FDA submission, and certain protocols are applied during the submission of ECTDs.

Short overview of FDA

The FDA or the Food and Drug Administration is responsible for safeguarding public health by assuring medicines for humans and veterinary use, ensuring the efficacy of biotechnological goods for human use, and monitoring radiation-emitting items sold in this country.

The study data

When we talk about the non-clinical or clinical study reports, the data is about the person to undergo clinical trials. It includes information about the demography, details of the medical treatment, the description of the participant’s progress, and other relevant information. Non-clinical research data is a term used to describe the information collected in previous experiments on animals.

Types of submissions to the regulatory agencies

These sorts of applications are subject to all future submissions, including revisions and additions.

The FDA submission and the other regulatory agencies have established a network seeing the current modernization circumstances; they have established a general framework that allows you to submit your study data. The FDA is instituting new requirements for data standards that will be applied to most studied data submitted to the FDA, Centre for Drug Evaluation and Research (CDER).

Data Standard Catalogue

The FDA and other agencies set up the Data Standard Catalogue, and this Catalogue comprises of the study data standards which were developed a part of the collaboration between the FDA and CDISC (Clinical Data Interchange Standard Consortium) to ensure the data about the clinical and nonclinical studies may go to the FDA in a set pattern which all companies and the standards will follow have been established to ensure uniformity in the submission through different manufacturers, and it can be reviewed easily.

It was decided, the Sponsors whose studies were started after Dec 17, 2106, must submit data formats supported by FDA and listed in the FDA Data Standard Catalogue. This applies to NDAs, BLAs, and subsequent submissions to these types of applications.