(Source: https://pltfrm.com.cn)
The registration and approval process for launching drugs in China can be complex and involves several steps. The process is overseen by the China National Medical Products Administration (NMPA). Here is an overview of the typical registration and approval process:
1.Preclinical Research and Development:
Before entering the Chinese market, pharmaceutical companies typically conduct preclinical research and development to gather data on the drug’s safety and efficacy.
2.Clinical Trials:
Conduct clinical trials in China to provide evidence of the drug’s safety and efficacy in the Chinese population.
Clinical trial data must be submitted to the NMPA as part of the registration dossier.
3.New Drug Application (NDA):
Prepare a New Drug Application (NDA) dossier that includes comprehensive information about the drug, including preclinical and clinical data, manufacturing processes, and quality control.
The NDA dossier must comply with Chinese regulatory requirements.
4.Submission to the NMPA:
Submit the NDA dossier to the NMPA for review and approval.
The NMPA reviews the dossier for data integrity, compliance with regulations, and safety and efficacy.
5.Review Process:
The NMPA conducts a review of the NDA dossier, which includes technical reviews, safety assessments, and efficacy evaluations.
The review process may involve multiple cycles of questions, clarifications, and additional data requests from the NMPA.
6.Onsite Inspections:
The NMPA may conduct onsite inspections of manufacturing facilities to ensure compliance with Good Manufacturing Practices (GMP).
7.Approval Decision:
If the NMPA is satisfied with the data and documentation, they will grant approval for the drug to be marketed in China.
If any issues or deficiencies are identified, the applicant must address them to the satisfaction of the NMPA before approval is granted.
8.National Reimbursement Drug List (NRDL):
For drugs intended to be included in the National Reimbursement Drug List (NRDL), a separate negotiation and pricing approval process may be required.
9.Post-Marketing Surveillance:
After approval, the drug must undergo post-marketing surveillance to monitor safety and efficacy in real-world conditions.
Adverse drug reactions (ADRs) must be reported to the NMPA’s Center for Adverse Drug Reactions Monitoring (CADRMP).
10.Pharmacovigilance:
Pharmaceutical companies are required to establish pharmacovigilance systems to monitor and report adverse drug reactions.
11.Annual Reports:
Annual reports on the drug’s safety and efficacy must be submitted to the NMPA.
12.Renewal and Variations:
Drugs in China require periodic renewal of their registration. Any variations to the drug, such as changes in formulation or manufacturing site, require approval.
It’s important to note that the registration and approval process can vary depending on the type of drug (e.g., new chemical entity, generic drug, biologic) and its intended use. The timeline for approval can also vary, with some drugs taking several years to gain approval in China.
Pharmaceutical companies planning to launch drugs in China should work closely with regulatory experts and legal counsel to navigate the regulatory requirements and ensure compliance with Chinese regulations.
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