Pharmacovigilance in China

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Pharmacovigilance in China

Pharmacovigilance in China Services

China Pharmacovigilance (PV) regulatory system opened a new chapter in 2019 when it included the new provision of“Establishing Pharmacovigilance System” in “China Drug Administration Law”. Soon after, National Medical Products Administration (NMPA) in December 2020 drafted“Good Pharmacovigilance Practice” (GVP) to clarify and standardize the obligations and responsibilities of MAHs and Sponsors in Pharmacovigilance (abbreviated as “PV”).

Accestra Consulting provides comprehensive pharmacovigilance services to ensure compliance with China Good Pharmacovigilance Practice (GVP) according to NMPA requirements for post-marketing authorization. Our services align and reference International Conference on Harmonisation (ICH), FDA and EMA standards. These services include but not limited to the following below:

Post-marketing Pharmacovigilance in China Services include:

1. China QPPV – Qualified Person for Pharmacovigilance & QMS

PV department set up to explicate the responsibilities of qualified personnel for PV
Rules formulated for PV safety committee
Standard operating procedure (SOP) customized for post-marketing PV activities

2. China ICSR management – Processing and Submission of Post-marketing Individual Case Safety Reports

Case intake and triage
Data entry including MedDRA coding
Quality control and submission to ADR center reporting system

3. Literature Screening

Searching and reviewing global literature and Chinese literature
Global/Chinese literature downloaded and generated into report
Translation of literature identified as ICSR from English to Chinese
ICSR case processing from literature

4. Preparation of Periodic Safety Update Report (PSUR)

Data collection, communication and confirmation
Searching and aggregating literature as well as processing case ICSRs
Drawing safety conclusion with preparation list and summary table of cases
Reviewing and revising PSUR by communicating with client

5. China Risk Management Plan (RMP)

Data collection, analysis and evaluation
Tailored product safety profile
Preparation of PV activities and implementation of risk minimization measures
Producing and reviewing RMP

6. Preparation of Safety Annual Report

Data processing
Generating safety annual report
Reviewing and revising safety annual report via communicating with client

7. Preparation of PV System Master Files (PSMF)

Creating initial and final draft of PSMF in compliance with the legal requirements in China once the technical guideline of PV to be released