Key Updates In New Version Of China GMP Compared With Old Version
2022-04-12
On March 22, 2022, NMPA published the updated version of China GMP (Good Manufacturing Practice) and GSP (Good Supply Practice). The new GMP and GSP will take effective since May 1st, 2022. BradyKnows QA team made assessment and summarized key updates in new version of China GMP compared with old version as below:
1.Fully implement the medical device registrant filing entity system, and strictly implement the main responsibility of the enterprise. The following impacts are mainly aimed at enterprises that entrust production.
Allow the entrusted production enterprise to apply for the production license with the registration certificate of the registrant.
Abolish the restriction of entrusted production filing and the restriction that only one enterprise can be entrusted to produce the same product at the same period.
Clarify the responsibilities and obligations of both the registrant and the entrusted manufacturer, stipulate that the registrant is responsible for the quality and safety of medical devices, and the entrusted manufacturer is responsible for the production behavior. The registrant is responsible for listing release.
Clarify the registrant’s inspection responsibilities, inspection methods, results handling, investigation and evidence collection and other regulatory requirements in the case of cross-provincial entrusted production.
2.Simplify relevant application materials and procedural requirements. The following impacts are mainly aimed at production enterprises.
Abolish the “copy of business license” required to apply for a medical device production license and apply for Class I medical device production filing.
The review time limit for medical device production license applications has been adjusted from 30 working days to 20 working days.
If the medical device filing entity produces the Class I medical device by itself, it can go through the production filing together with the product filing.
3.Enrich and improve supervision means, improve operability, and solve practical problems in supervision.
Establish a medical device reporting system. Four forms of reporting, annual report, production product variety report, production condition change report and re-production report are stipulated; as perspective of self-inspection report system, for import medical device registrants and filing entities, their legal agent shall submit self-inspection report to local NMPA at the location of legal agent before March 31 of the following year.
Diversify inspection methods: supervision inspection, key inspection, follow-up inspection, causal inspection and special inspection and other forms of supervision and inspection.
Refine and clarify information disclosure and responsibility interview system: If medical device registrants, filing entities and entrusted manufacturers fail to take effective measures to eliminate the existing medical device quality and safety risks, the drug regulatory department may conduct a responsibility interview on the registrant, filing party, the legal representative of the entrusted production enterprise.
Strengthen the informatization construction of medical device production supervision.
4.Strengthen risk management and increase penalties for illegal acts.
If it is clear that the medical device produced causes harm to the human body or there is evidence that it may endanger human health, the drug supervision and administration department may take emergency control measures to suspend production, import, operation and use;
If the registrant, filing entity and legal agent of imported medical devices refuse, obstruct, delay, or evade the overseas inspection organized by NMPA, resulting in the inability to carry out the inspection work and the inability to confirm the effective operation of the quality management system, and there are evidences to prove those able to cause human body, NMPA can punish them in accordance with regulations.
Increase the penalties for illegal acts and increase the corresponding penalty requirements according to the needs of supervision.
Clarify credit files and the punishment system for dishonesty, require the establishment of credit files, and implement punishments for dishonesty according to the actual situation.
