The specific process of nmpa registration application is as follows:
1. Preparation stage
Determine the type of application: Determine the applicable registration classification according to the type of drug and its use, for example, registration of new drugs, registration of generic drugs and so on. Prepare technical documents: According to the type of application, prepare complete technical documents, including drug quality data, clinical trial data, manufacturing process and quality control information.
2. Submit registration application
Submit the registration application form and relevant technical documents to NMPA within the time specified by NMPA in China. Payment of registration fees: Pay the relevant registration fees in accordance with the regulations.
3. Evaluation stage
Acceptance: nmpa will conduct preliminary acceptance of the submitted registration application and check the completeness and compliance of the application documents. Technical Review: nmpa will conduct a technical review of the application documents, including assessment and review of drug quality, efficacy, safety and other aspects. Clinical Review: The nmpa will conduct a review of the clinical trial data to ensure that the efficacy and safety of the drug meets the requirements.
4. Approval Decision
Based on the results of the review and the applicant's response, the NMPA will make an approval decision on whether to approve the registration application. If the registration application is approved, the NMPA will issue a notice of approval and list the registered drug in the Drug Registry.
5. Issuance Stage
Issuance of Certificate of Registration: NMPA will issue a certificate of registration to the applicant, proving that the drug has been approved for registration by NMPA in China.
Meaning of NMPA:
NMPA is the abbreviation of State Drug Administration of China (SDA), which is mainly responsible for the supervision and management of medicines, medical devices and other medical supplies. nmpa's responsibilities include formulating the relevant regulations and standards of medicines, medical devices and other medical supplies, supervising the production, sale and use of medical supplies, and ensuring the safety of public medicines. The nmpa's responsibilities include formulating regulations and standards related to medicines, medical devices and other medical supplies, regulating the production, sale and use of medical supplies, and safeguarding the safety and rights of the public.
Through nmpa certification, manufacturers can ensure that their products comply with China's regulatory requirements and standards, and obtain the legal qualification to sell in the Chinese market. nmpa certification is an important step to enter the Chinese medical device market. According to the Medical Device Manufacturing Supervision and Management Measures issued by the NMPA, a medical device manufacturer's license is required to start a Class II and Class III medical device manufacturing business in China.