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Pharmacovigilance Services in Malaysia

Adverse drug reaction (ADR) reporting is a pivotal aspect of pharmacovigilance. In Malaysia, the Drug Control authority (DCA) is responsible for carrying out these activities for the safe use of products registered with DCA. The Malaysian Adverse Drug Reaction Adverse Committee (MADRAC), an advisory body of DCA, oversees and runs the pharmacovigilance program. Currently, it is voluntary for healthcare professionals (HCPs) and mandatory for product registration holders (PRH) to report any adverse event with respect to the products. ADRs can be reported via posts, fax, email, and online reporting. Malaysia has separate forms for healthcare professionals (HCPS), product registration holders (PRH), and the general public. HCPs can report through a prepaid blue form or online reporting form, and the general public can report through Consumer Side Effect Reporting Form (ConSERF). There is a separate reporting form for parents/guardians or vaccinee for the minor adverse event following immunization namely ‘Borang Pemantauan Kesan Sampingan Ringan Selepas Pelalian’ and PRH can report through Suspect Adverse Reaction Report Form (CIOMS Form I). One of the major PV challenges in Malaysia is the underreporting of ADRs by the HCPs and public.

AAs a leading global contender, DDReg understands the significance of patient safety right from clinical trials to post-marketing surveillance of medicinal products. As part of our safety services portfolio, we provide end-to-end pharmacovigilance services in Malaysia that include adverse drug reaction reporting, signal detection & management, aggregate report writing, development of customized pharmacovigilance plans/risk management plans in accordance with the local requirements and good pharmacovigilance practices.

DDReg pharmacovigilance Services portfolio include:

ICSR Processing and Submission

  • Triage of initial and follow-up ICSRs, SUSARs,
  • Case Processing through E2B(R3) compliant databases and other relevant databases integrated with Drug dictionary (WHO DD) and MedDRA
  • Quality Check, Medical reviews
  • Submission of cases as per agency timelines
  • Maintaining ICSR Case Processing & tracking sheets
  • Reconciliation process with customers

Risk Management Plan

  • Drafting, reviewing, and maintaining RMPs and REMS while providing support through submission methods
  • Preparing customized procedures to classify safety risks and deliver tailored risk management strategies
  • Assessment of potential risks and missing information and prepare reports that recommend risk management methods
  • Implementation of supplementary measures, including Post-Authorization Safety Studies (PASS), such as developing academic materials, observational examinations, and targeted follow-up questionnaires
  • Effectively convey risks through labelling means such as Summary of Product Characteristics (SmPC) and patient information leaflet (PIL) (PIL)

Aggregate Reports

  • Periodic Safety Update Report (PSURs)
  • Development Safety Update Reports (DSURs)
  • Annual Safety Reports (ASRs)

Signal Management

  • Identification new safety signals and/or changes in risks concerning a pharmaceutical product from ICSR database, literature, aggregate reports as well as regulatory agency website monitoring.
  • Provide recommendations from signal assessments which include risk minimization approaches
  • Preparation of Signal Management Tracker, Annual Signal Reports.

Responsible person for pharmacovigilance (RPPV) Services

  • Review of PSMF, SDEA agreements, agreements with commercial partners, PV SOPs etc.
  • Review & sign off of Aggregate reports, Signal Reports and RMPs
  • Retainer services for RPPV and Deputy
  • Monthly reconciliation
  • Medical review of Signal detection ; Signal Surveillance Meetings (Quarterly)
  • Monthly Communication report/provision of compliance metrics
  • PV Quality Management System Oversight

PV Audit & Compliance

  • Review Audit and Compliance to applicable PV guidelines, regulations, Safety Data Exchange Agreements (SDEAs), SOPs (standard operating procedures) and work instructions
  • Optimize well-constructed audit plans as well as mock audits to prepare customer organizations for PV inspections conducted by respective competent authority.
  • Conduct regular gap assessments of PV staff at site location
  • Provide organizational training on safety audits and inspections
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