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What post-market monitoring mechanisms are in place to ensure the ongoing safety and efficacy of medicinal products after marketing authorisation has been granted?
The primary post-market obligations for a marketing authorisation holder include:
- pharmacovigilance, especially monitoring and reporting adverse drug reactions;
- monitoring and evaluating the manufacturing process, quality, stability, efficacy and adverse drug reactions of a new drug during the new drug monitoring period;
- product quality control and compliance with good manufacturing practices;
- product recall;
- renewal of marketing authorisation upon expiry;
- amendment of marketing authorisation to reflect changes in the product licence; and
- conduct of Phase IV clinical studies as required by the China Food and Drug Administration (CFDA). Phase IV trials can be imposed as part of the marketing authorisation if the CFDA finds it necessary to confirm further the safety and efficacy of a new drug through post-market studies on a much larger population.
The application for marketing authorisation renewal can be rejected if the therapeutic efficacy is uncertain or if serious adverse drug reactions or other factors harmful to human health are found during drug safety re-evaluation by the CFDA.
In addition, granted marketing authorisations can be revoked under the following circumstances:
- The holder asks to annul its marketing authorisation before expiry.
- The drug manufacturing permit is revoked.
- Serious adverse drug reactions or other hazards to human health are found to be associated with a drug.
- The holder fails to meet the requirements for marketing or the Phase IV clinical trial requirements as imposed by the CFDA.
- Serious mislabelling of a drug is identified.
Post-market drug safety re-evaluation by the CFDA may also lead to mandatory changes to the granted marketing authorisations (eg, to modify the package insert of a drug or to switch an over-the-counter drug to a new prescription drug classification).
What data protection issues should be considered when conducting pharmacovigilance activities?
Patient data obtained during adverse events reporting and monitoring must remain confidential. Medical records in both physical and electronic format must be exclusively maintained and used by healthcare professionals at medical institutions and can be revealed to relevant third parties only under exceptional circumstances.
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