Background
On September 30, 2018, China’s National Medical Products Administration (NMPA) issued the “Announcement on Direct Reporting of Adverse Drug Reactions by Marketing Authorization Holders”, outlining key requirements for Marketing Authorization Holders (MAHs) to take greater responsibility in monitoring, reporting, and managing adverse drug reactions (ADRs). This policy aims to elevate the pharmaceutical industry’s awareness of drug safety, strengthen China’s ADR monitoring framework, align with international standards such as ICH guidelines, and enhance the overall safety and risk management of pharmaceuticals in the country. This announcement sets detailed expectations for MAHs regarding ADR systems, personnel qualifications, reporting timelines, and collaboration with regulatory authorities to ensure public safety and compliance. It covers eight critical areas:
1. Adverse Reaction Monitoring System
The adverse reaction monitoring system is a comprehensive framework established by MAHs to fulfill their monitoring responsibilities effectively. The system includes:
- Specialized institutions and personnel: MAHs must establish dedicated departments with qualified staff possessing expertise in medicine, pharmacy, epidemiology, or statistics. These professionals must be capable of analyzing adverse reaction reports and assessing drug risks.
- Monitoring and management protocols: MAHs should develop mechanisms for adverse reaction reporting, information collection, risk identification, and benefit-risk assessments. Continuous monitoring ensures that drug benefits outweigh risks.
- Integration of digital tools: MAHs should utilize information technology to ensure smooth operations and meet international data transmission requirements.
2. Requirements For The Individual In Charge Of Adverse Drug Reaction Monitoring
The individual responsible for overseeing the adverse reaction monitoring system, designated by the MAH, must hold a leadership position and oversee ADR monitoring activities. This person must have:
- Extensive experience in adverse reaction monitoring.
- Familiarity with relevant regulations and policies.
- Competence in establishing and maintaining the monitoring system, ensuring sustained adherence to pharmacovigilance standards.
3. Outsourcing ADR Monitoring Activities by MAHs
MAHs may outsource ADR monitoring tasks to qualified entities such as research institutions, clinical trial organizations (CROs), pharmaceutical manufacturers or distributors, and intelligence or other qualified third party agencies. These tasks include post-marketing studies, safety data collection, literature reviews, and related activities.
Overseas MAHs are advised to appoint a single local representative to manage ADR monitoring, evaluation, and risk control for imported drugs. An entrustment agreement should be signed between both parties. The local representative must establish a robust ADR monitoring system and comply with regulatory inspections.
4. Overseas ADR Reporting: Timelines and Submission Pathways
The timeline for reporting adverse reactions for imported drugs starts from the date the overseas MAH is notified of the event.
Due to the high volume of overseas reports, submitting individual ADR forms for each case may be impractical. To address this, safety reports should be submitted using the E2B format, which streamlines data submission and ensures compliance with international standards.
5. Reporting by Healthcare Institutions and Pharmaceutical Distributors
- Healthcare institutions will continue to report adverse reactions using the existing channels and timelines.
- Until December 31, 2018, pharmaceutical distributors can report adverse reactions via current methods or directly to the MAHs.
6. Managing Health Authority Feedback on ADRs
From January 1, 2019, MAHs are required to promptly analyze and evaluate feedback reports from the National ADR Monitoring System. Upon receiving a feedback report, Individual Case Safety Reports (ICSRs) must be submitted to the MAH’s direct reporting system within the prescribed scope and timeline. Detailed submission guidelines are available on the National Center for ADR Monitoring’s official website.
7. Managing ADR Clustering Trends
MAHs must pay close attention to unusual increases in ADR reports or patterns suggesting batch-specific clustering. A clustering trend occurs when multiple ADR cases with similar clinical symptoms (e.g., chills, fever) arise within a short timeframe from the same or adjacent batches of a drug.
Upon identifying clustering trends, MAHs must promptly evaluate the cases and conduct risk investigations. If safety risks are confirmed, the MAH must immediately communicate with the provincial ADR monitoring center and implement necessary risk control measures for the affected batches.
8. Annual Report Requirements
MAHs must submit a Pharmacovigilance Annual Summary Report summarizing ADR monitoring activities for the previous year by March 31st each year. The guidelines for preparing this report are outlined in the “Interim Writing Guideline for Drug MAH Pharmacovigilance Annual Report” (NMPA, November 29, 2019), accessible on the National Center for ADR Monitoring’s website.
Contact Us
Looking for expert support with your pharmacovigilance (PV) activities in China? Whether you need a reliable local representative or an audit of your local partner, our team of seasoned professionals is here to help you navigate the complexities of PV compliance.
Contact us at info@accestra.com or visit China PV Hub for more information and to learn more about how we can support you.
Source: https://www.nmpa.gov.cn/xxgk/zhcjd/zhcjdyp/20180930174701302.html