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Regulatory submissions are essential in the pharmaceutical and biotech sectors as they play a key role in introducing new therapies to the market and maintaining compliance. Companies in the United States (US) and the European Union (EU) must have a thorough understanding of the different types of submissions mandated by Regulatory authorities. These submissions, ranging from clinical trial applications to post-approval commitments, serve distinct purposes in the process of drug development and approval. The purpose of this blog post is to offer a thorough examination of the typical varieties of Regulatory submissions in the United States and European Union, as well as a summarized table for easy reference.
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1. Clinical Trial Applications
are presented to Regulatory bodies to start clinical trials for experimental medications in human subjects. In the United States, the Food and Drug Administration (FDA) mandates the submission of an Investigational New Drug (IND) application. Conversely, in the European Union, the application is referred to as a Clinical Trial Application (CTA) and is submitted to the appropriate national Regulatory authority or ethics committee.
2. Chemistry, Manufacturing, and Controls (CMC) Information Amendments
CMC information amendments are changes made to the data related to the chemistry, manufacturing, and control of a drug product that is included in an IND or marketing application. These amendments are necessary to provide Regulatory agencies with the most current information on the quality and consistency of the drug product.
3. Marketing Applications
Marketing applications are filed to obtain permission to sell a drug product. In the United States, these applications consist of New Drug Applications (NDAs) for pharmaceuticals and Biologics License Applications (BLAs) for biologics. In the European Union, Marketing Authorization Applications (MAAs) are submitted to the European Medicines Agency (EMA) for centralized approval or to national competent authorities for decentralized or mutual recognition processes.
4. Applications for Modifications of Submissions
Requests for changes to previously submitted applications or the addition of requested data are made through applications for modifications. Such changes could involve adjustments to the clinical trial protocol, manufacturing process, or labeling in response to Regulatory agencies' requirements.
5. Availing Contract Services
Pharmaceutical companies can use contract services to delegate specific tasks related to drug development and Regulatory activities, like managing clinical trials, providing Regulatory support, and manufacturing services. Although not a conventional Regulatory submission, utilizing contract services is vital for the drug development process as a whole.
6. Responses to Agency Inquiries During the Review
Regulatory agencies frequently ask for more information or clarification during the review of submissions, prompting companies to respond promptly and thoroughly to address any concerns and facilitate the process.
7. Post-Approval Commitment Submissions
Post-approval submissions consist of meeting Regulatory requirements that were agreed upon when the marketing authorization was approved. These commitments might involve carrying out studies after the product has been marketed, providing safety reports at regular intervals, or putting into place plans to manage risks and oversee the safety and effectiveness of the drug after approval.
Tabular Summary of Regulatory Submissions
| Regulatory Submission | US | EU |
| Clinical Trial Applications | Investigational New Drug (IND) | Clinical Trial Application (CTA) |
| Chemistry, Manufacturing, and | CMC Information Amendments | CMC Information Amendments |
| Marketing Applications | New Drug Application (NDA) | Marketing Authorization Application (MAA) or National Procedure |
| Biologics License Application (BLA) | (Decentralized/Mutual Recognition) | |
| Applications for Modifications of Submissions | Modifications to IND or NDA | Modifications to CTA or MAA |
| Availing Contract Services | Outsourcing various aspects of drug development and Regulatory activities | Similar outsourcing practices, no specific Regulatory submission required |
| Responses to Agency Inquiries | Providing additional information or clarification | Providing additional information or clarification |
| During the Review | as requested by Regulatory agencies | as requested by Regulatory agencies |
| Post-Approval Commitment Submissions | Fulfilling Regulatory obligations post-approval | Fulfilling Regulatory obligations post-approval |
Understanding the nuances of Regulatory submissions and navigating the complex Regulatory landscape in the US and EU are critical for companies seeking to bring new therapies to market and maintain compliance throughout the product lifecycle. By effectively managing Regulatory submissions and ensuring timely and accurate responses to Regulatory agencies, companies can expedite the approval process and bring innovative treatments to patients in need. A seasoned Regulatory partner like Freyr can assist in adhering to the Regulatory requirements to achieve successful outcomes in the US and EU markets as Regulatory submissions play a pivotal role in the drug development and approval process.
