On April 15, China’s National Medical Products Administration (NMPA) unveiled the Inspection Guideline for Pharmacovigilance, signaling a critical step in bolstering the oversight of pharmacovigilance activities. This comprehensive guideline underscores the pivotal role of provincial drug regulatory departments and places a significant onus on marketing authorization holders (MAH) to actively engage in and uphold pharmacovigilance responsibilities.

Accestra has distilled key facets of the guideline, delving into the intricate details of routine inspections. These encompass a nuanced examination of drug characteristics, encapsulating safety attributes, adverse drug reaction (ADR) monitoring data, and the clustering of ADR events. The spotlight also falls on drugs with substantial market presence or minimal substitutes, those approved for marketing with additional safety conditions, innovative drugs, improved new drugs, and drugs tailored for specific demographics like children and pregnant women. Notably, the guideline also directs attention to drugs with high social concern.

Further, the guideline contemplates MAH characteristics, outlining considerations for those with a diverse array of drugs and a sizable sales volume. It sheds light on the inspection history of MAH, highlighting the significance of vigilance for those undergoing transformative changes in their pharmacovigilance systems due to factors such as mergers, acquisitions, or organizational restructuring. Additionally, it scrutinizes MAH entrusting production to external entities and those actively conducting pharmacovigilance activities.

Supplementing routine inspections are additional factors such as an assessment of previous drugs and any circumstances deemed necessary by the supervisory authority for further investigation. This comprehensive approach aims to fortify the pharmacovigilance landscape and ensure a thorough examination of potential risks.

Moving into the realm of for-cause inspections, the guideline meticulously delineates factors triggering such scrutiny. Late, concealed, or missing reports of ADR, indications of potential safety risks from ADR monitoring, and failures in identifying, evaluating, controlling, or communicating relevant risks are key considerations. Non-compliance with reporting obligations to the drug regulatory authority following the suspension of drug production, sales, use, or recall is highlighted, as is the failure to conduct post-marketing safety research and implement required pharmacovigilance plans. Additionally, inadequacies in providing relevant pharmacovigilance materials or discrepancies in meeting specified requirements may necessitate for-cause inspections.

The inspection process, as outlined in the guideline, provides flexibility through on-site and remote inspection modalities. On-site inspections involve inspectors physically visiting venues where MAH conducts pharmacovigilance activities, while remote inspections leverage technology such as video calls. The guideline empowers the inspection group to determine the need for on-site or remote inspections and may require MAHs to submit relevant information within specified timeframes.

Risk levels of defects are categorized into three tiers—severe, major, and common. The guideline incorporates a dynamic approach, with repeated defects potentially leading to an escalation in defect levels. The inspection itself comprises an exhaustive checklist of 100 items, encompassing 12 severe defects (marked as “**”), 40 major defects (marked as “*”), and 48 common defects.

Evaluation standards add another layer of rigor to the process, concluding with one of three outcomes: “requirements met,” “requirements basically met,” or “fail to meet requirements.” The meticulous criteria for a “requirements met” conclusion involve the absence of severe or major defects and a count of 0-9 common defects. Conversely, a “fail to meet requirements” determination occurs under specific circumstances, such as the discovery of one or more severe defects, the absence of severe defects but the identification of 10 or more major defects, or the absence of severe defects but 0-9 major defects with a total defect count of 25 or more. All other scenarios fall under the “requirements basically met” category.

In essence, this guideline marks a substantial stride in elevating the standards of pharmacovigilance inspections, providing a robust framework to safeguard public health and reinforce the integrity of the pharmaceutical landscape in China.

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