What is the process for obtaining approval via Form MD-23?
After submitting Form MD-22, the CDSCO reviews the application to ensure compliance with regulatory requirements. If the application meets all criteria, the authority issues Form MD-23, granting permission to commence the clinical investigation. This approval indicates that the proposed study adheres to ethical standards and regulatory guidelines.
Timely and accurate submission of Form MD-22, followed by the issuance of Form MD-23, ensures that the clinical trial can proceed without unnecessary delays. Understanding the requirements and preparing comprehensive applications can expedite the approval process.
For more detailed information, you can refer to CliniExperts' overview of Forms MD-22 and MD-23.
