What is OTC Drug Product Registration?
Over-the-counter or OTC drugs are safe to use medicines that do not require prescriptions across the globe. OTC drugs are developed under the New Drug Application (NDA) Process or the OTC Monograph Process. The review of OTC by the US Food and Drug Administration (FDA) is handled by the Centre for Drug Evaluation and Research (CDER).
Who needs OTC Drug Product Registration?
- If you are a sponsor seeking to market its product OTC, either as a new NDA or as a switch from your prescription product.
- An OTC Drug Product is classified based on its intended use. If your drug product has claims on its labelling and its ingredients have a well-known therapeutic use, you will need to register your OTC drug product.
What is the process for OTC Drug Product Registration?
- You will apply to the Division of Nonprescription Drug Products (DNDP) in the Office of Drug Evaluation IV.
- The DNDP will oversee the drug development, the review and regulatory action on Investigational New Drugs (INDs).
- The DNDP will then obtain input from the specific subject matter review division (SSMRD) during the development process.
- Once the sponsor submits an NDA, DNDP reviews the consumer studies, the post marketing safety data, the OTC labelling, and any other regulatory issues.
How can Perfect Pharmaceuticals Consultants help?
We at Perfect Pharmaceuticals Consultants can help you in the preparation and submission of your files for OTC Drug Product Registration. With an experience of more than 20 years, we know the exact process and can make it a smooth one for you. Click on the <button> now to get your OTC drug product registered hassle-free.