According to our sources, the SAMR is now soliciting opinions from provincial authorities on the revision of Administrative Measures for FSMP Registration. Compared to the version released in 2016[1], here are the main revisions.
Main Revisions
Stricter registration review requirements
Requirements for production
Specified legal basis for sampling inspection
Stringent supervision requirements
10 situations in which a registration application will be rejected are detailed:
Application or product not compliant with Food Safety Law and related laws and regulations
Failed to comply with the national standards of FSMP and corresponding technique requirements
The statements/information in the application materials are falsified.
Application material and supporting data cannot substantiate product safety and/or lacks sufficient evidence to support clinical efficacy.
Applicants fail to confirm the onsite inspection before the deadline, refuse or do not cooperate in the onsite inspection and sampling inspection
The information on production facilities etc. in the application materials do not correspond to the actual situation verified during onsite inspection. Or applicants fail to or refuse to rectify problems raised by officials during the onsite inspection.
Unqualified product examination report. The examination result shows the determination methods used are not scientific
Applicants fail to submit supplementary materials before the deadline, or the supplementary materials submitted are still noncompliant.
Applicants have violated laws severely and are listed in the credit blacklist
Others
Regulations about the renewal of the registration
The same recipe cannot be used to apply for products with different product names. It is also not permitted to use the same name to register different FSMP recipes.
Strongest punishment and accountability requirements
Applicants involved in crimes will be brought to public security bureaus for further investigation of criminal liabilities.
Application from applicants that are listed in the credit blacklist will be rejected. For those that have obtained the certificate already, the certificate will be revoked.
SAMR at the provincial level shall assist the onsite inspection conducted by the national level SAMR authority. Besides, all the experts, authorities that have participated in the registration review shall be responsible for their opinions or report.
Implementing the principle of "streamlining administration, delegating powers, and improving regulation and services" reform
Applicants are encouraged to carry out research and development activities together with universities and scientific research institutions.
30 days will be given for applicants to prepare for onsite inspection.
Inspection authorities shall complete the onsite inspection of clinical trials within 30 days, 10 days shorter than before.
The alteration of manufacturers’ names and their addresses will be verified and approved onsite.
Ensure the legal force of E-certificates.
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