DDReg Pharma

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.

As 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
Risk Management Plan
Aggregate Reports
Signal Management
Responsible person for pharmacovigilance (RPPV) Services
PV Audit & Compliance
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