Periosteal stripping ion NMPA domestic registration certificate"and so on"It usually refers to the process of comparing the relevant documents of a drug or medical device that has been approved or registered abroad with the domestic registration requirements to verify that it complies with domestic regulations and standards.
Specifically, the purpose of the comparison is to confirm whether the foreign approval documents or registration certificates submitted by the applicant are in compliance with the relevant provisions of the NMPA, so as to simplify the registration approval process while meeting the domestic requirements. This approach helps to avoid duplicate clinical trials and tedious testing, and improves the efficiency of the registration process.
Equivalence pairs typically require the following steps:
Confirm the completeness of the foreign registration information: Ensure that the foreign registration certificate and documents submitted are complete and accurate.
Comparison of domestic and foreign requirements: Compare foreign registration requirements with relevant regulations and standards of China's NMPA to ensure that foreign registration documents cover all the requirements of domestic registration.
Determine equivalence: Verify that the foreign registration certificate is equivalent to the registration requirements of China, i.e., whether it has a comparable level of technology and regulations.
Provide necessary additional information: If there are discrepancies or deficiencies, additional information may need to be provided or adjustments may be made to meet domestic requirements.
Submission of Comparison Report: The results of the comparison are submitted to the NMPA in the form of a report as part of the application for registration.
Equivalence helps to speed up the process of registering products in the Chinese market, but it is necessary to ensure the quality, completeness and compliance of foreign registration documents. This process is usually initiated at an early stage of the registration application to ensure a smooth follow-up process.