DDReg Pharma

Pharmacovigilance Services in Philippines

Every side-effect that is reported improves the safety profile of the medicinal product or medical devices. Food and Drug Administration (FDA) of the Philippines-Pharmacovigilance section is the National Pharmacovigilance Centre that oversees reporting of suspected adverse drug reactions (ADRs) from various sources including, manufacturers, healthcare professionals, consumers, hospitals, and various public health programs. Adverse events (AE) can be reported by HCPs, other health professionals, consumers, and manufacturers via the “Online Adverse Drug Reactions Reporting” form by completing the form online or by downloading the form, filling in the details, and sending it via email or mail to the FDA. ADRs can also be reported via telephone. Once the reports are submitted, the reports are entered into the national database and follow-ups are initiated for any incomplete information. The Philippines FDA then evaluates the reports for any new risks to consider any need for action and take appropriate measures. Moreover, the use of traditional medicine is on a higher level in the Philippines, therefore most of the AEs are missed, and under-reported due to uncertainty.

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 Philippines 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
Other PV Services
PV Audit & Compliance
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