(Source: https://pltfrm.com.cn)
In China, drug regulation and reporting of adverse reactions are governed by the China National Medical Products Administration (NMPA) and its subsidiary, the Center for Adverse Drug Reactions Monitoring (CADRMP). Here are the key requirements for drug regulation and reporting adverse reactions in China:
1.Drug Registration:
Before a pharmaceutical product can be marketed in China, it must undergo a drug registration process with the NMPA. This process involves submitting comprehensive documentation on the drug’s safety, efficacy, and quality.
Clinical trials are required to demonstrate the safety and efficacy of the drug.
2.Adverse Drug Reaction (ADR) Reporting:
Healthcare professionals, manufacturers, and consumers are required to report any adverse reactions or side effects associated with drugs to the CADRMP.
Adverse reactions can be reported through the National ADR Reporting System (NADRIS), which is an online platform managed by the CADRMP.
3.Mandatory Reporting:
Manufacturers of pharmaceutical products are required to monitor and report adverse reactions associated with their products. They must also conduct post-marketing surveillance to identify and report adverse reactions.
Healthcare institutions and healthcare professionals are obligated to report serious adverse drug reactions.
4.Reporting Timelines:
Adverse reactions should be reported as soon as possible after they are identified, especially if they are serious or unexpected.
Manufacturers are required to submit periodic safety update reports (PSURs) to the NMPA detailing the safety profile of their products.
5.Serious ADRs:
Serious adverse drug reactions must be reported within 24 hours after being identified. This includes reactions that result in death, life-threatening conditions, hospitalization, disability, and other severe outcomes.
6.Non-Serious ADRs:
Non-serious adverse drug reactions should be reported within 15 days after identification.
7.Data Collection and Evaluation:
The CADRMP collects and evaluates ADR reports to assess the safety of pharmaceutical products in the Chinese market.
Data from ADR reports can lead to regulatory actions, including label changes, warnings, or even product recalls.
8.Pharmacovigilance System:
Pharmaceutical manufacturers are required to establish a pharmacovigilance system to monitor and manage adverse reactions associated with their products.
9.International Collaboration:
China collaborates with international organizations and regulatory agencies to enhance pharmacovigilance efforts and ensure drug safety.
10.Legal Obligations:
Failure to report adverse reactions or comply with pharmacovigilance requirements can result in legal penalties for manufacturers and healthcare professionals.
It’s important for pharmaceutical companies and healthcare professionals to be aware of these regulations and reporting requirements to ensure drug safety and compliance with Chinese law. Timely and accurate reporting of adverse reactions is essential for protecting public health and ensuring the safety of pharmaceutical products in the Chinese market.
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