DDReg Pharma

Pharmacovigilance Services in Indonesia

Indonesia is one of the nations with an evolving pharmacovigilance system that ensures drug safety to ensure patient safety. The food and drug control Agency (Badan POM) is the National Centre of Pharmacovigilance in Indonesia that oversees the safety, efficacy, and quality of drugs from pre-clinical to post-marketing surveillance. It is also involved in making guidelines, work plans, and policies and looks after collecting, evaluating, and assessing the benefit-risk ratio of ongoing drugs of the adverse drug reaction report received. Adverse event reporting in Indonesia is voluntary and can be reported by healthcare professionals in hospitals, private practice physicians, public health centres, pharmacists by submitting the Yellow form, and consumers/patients by reporting through an online adverse event reporting form. It is mandatory for marketing authorization holders (MAH) and manufacturers to report any adverse event that occurred by filling out and submitting the Council for International Organizations of Medical Sciences (CIOMS) form. Also, it is compulsory for pharmaceutical companies to have designated pharmacovigilance units with a pharmacovigilance responsible person.

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 Indonesia 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
Send us a Message