China Consults on the Draft of Good Pharmacovigilance Practices

China will implement more comprehensive and systematic pharmacovigilance requirements, such as signal detection and regular benefit-risk assessment. Pharmacovigilance also covers the monitoring and management of adverse drug events during clinical trials.
by Chris Wang/Grace Wang Mar 08, 2021

On Dec. 1, 2020, the National Medical Products Administration (NMPA) issued the draft of Good Pharmacovigilance Practices (GVP) for public comments1. Stakeholders could submit feedback to NMPA before Dec. 18, 2020.

The newly released draft was enacted in accordance with the Pharmaceutical Administration Law of the People's Republic of China2, which took effect on Dec. 1, 2019.

Highlights of the draft:

1. Who takes the main responsibility for pharmacovigilance? It stipulates the Marketing Authorization Holder (MAH) and Clinical Trial Sponsor (CTS) to assume the main responsibility of Pharmacovigilance, and requires the MAH to establish a pharmacovigilance system and carry out quality management.   

2. What to include in the pharmacovigilance? Apart from requirements for collecting, identifying, assessing, and controlling adverse drug reactions after marketing, pharmacovigilance also covers the monitoring and management of adverse drug events during clinical trials.

3. What's new? Based on Western developed countries' experience, the draft adds many new requirements, such as Signal Detection, regular Benefit-Risk Assessment, Safety Studies after Marketing Approval, Drug Risk Communication, Pharmacovigilance Plan Formulation, etc.

4. Risk Management. It pointed out that effective pharmacovigilance activities should be carried out in combination with drug varieties' safety characteristics to reduce the risk of drug use.

The new practice shows China's great progress in setting up more comprehensive and systematic pharmacovigilance systems to guard drug safety further. Hence, companies should be more aware of dealing with pharmacovigilance activities. Under the current Pharmaceutical Administration Law, pharmacovigilance is allowed to be delegated by third parties. Therefore, companies can cut their human resource costs for the pharmacovigilance team. Those with insufficient capabilities to complete the pharmacovigilance procedures can also ensure their products are up to standard with a third party's help.

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Chris Wang
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Grace Wang
ChemLinked Regulatory Analyst
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