Our Pharmacovigilance experts actively track evolving global regulations—so you don’t have to.
To help simplify pharmacovigilance, we stay ahead of new regulations, assess their impact on current practices, and recommend actions that empower professionals to update their MAH systems, processes, and procedures to ensure consistent compliance and drug safety.
This week, we examine the latest regulatory updates in Malaysia and what they mean for your organization.
What is the focus of the NPRA Malaysia’s GVP inspections for 2023-24?
The NPRA Malaysia’s GVP inspections for the period from January 1, 2023, to December 31, 2024, focus on several key areas including the management of Adverse Drug Reactions (ADRs), collection and collation of ADR/Adverse Events Following Immunization (AEFIs), quality management systems (QMS), and ongoing safety evaluations.
What were the common deficiencies found in the management of ADRs?
The inspections revealed several deficiencies in ADR management:
- Failure to submit valid ADR reports within the required timelines
- Deficiencies in conducting and documenting follow-ups
- Failure to submit follow-up ADR reports to NPRA
- Issues in handling duplicated ADR reports
- Problems in managing and updating local ADR logs or databases, leading to missing data
What issues were identified in the collection and collation of ADR/AEFIs?
The NPRA inspections identified the following issues:
- Lack of surveillance systems for special populations (e.g., pregnant women, breastfeeding individuals)
- Deficiencies in the reconciliation procedure and in conducting reconciliation from various sources of safety data
- Problems in global and local literature screening processes
What were the findings related to the Quality Management System (QMS)?
The inspections highlighted several deficiencies in the QMS:
- Absence or delay in conducting regular audits by Marketing Authorization Holders (MAHs) of their affiliates or service providers
- Deficiencies in Safety Data Exchange Agreement (SDEA) management
- Issues in training management for both pharmacovigilance (PV) and non-PV personnel
What ongoing safety evaluation issues were noted?
The NPRA inspections found the following issues in ongoing safety evaluations:
- No procedure for Issue Related Safety Summary reports (IRSR) for generic products
- Lack of evidence of performing any signal detection activities
- Late submission of Periodic Benefit Risk Evaluation Reports (PBRER)
How can EVERSANA help address these deficiencies?
EVERSANA offers an expert-led approach to pharmacovigilance, leveraging advanced GenAI technology to deliver the highest standards of compliance and quality. By partnering with EVERSANA’s experienced PV team, MAHs can address core system gaps and ensure they remain inspection-ready.
Author
Nitin is an accomplished professional with over 20 years of experience spanning Good Vigilance Practice (GVP), Good Clinical Practice (GCP), bioanalytical science and software validation. He previously held the Senior Manager – GVP QA…