**4. Pharmacovigilance regulatory framework of Singapore**

In 1993, Singapore created the pharmacovigilance unit (PVU) [formerly known as the Adverse Drug Reaction Monitoring Unit (ADRMU)]. In 1994, the unit became the WHO's 40th member of the WHO International Drug Monitoring Program for international drug safety cooperation. In Singapore adverse event monitoring of therapeutic products is done by their drug regulatory authority, Health Science Authority. Spontaneous Reporting of the adverse event can be done for therapeutic products, vaccines, complimentary therapeutic goods like traditional medicines, Chinese proprietary medicines, health supplements, cell tissue gene therapy products, cosmetics and medical devices as well by patients, healthcare professionals and industry to the HSA. Adverse events that are eligible to be reported are as follows:


Healthcare professionals (HCPs) can report adverse events electronically (report online or mobile-friendly e-form), or manually by filling out unique colour-coded forms and mailing them to the HSA's Vigilance and Compliance Branch, Health Product Regulation Group, or sending an email to HSA productsafety@hsa.gov.sg.


*Introductory Chapter: Pharmacovigilance Regulatory Framework of Three Asian Countries… DOI: http://dx.doi.org/10.5772/intechopen.109194*

Therapeutic product importers, distributors, retailers and registrants are all expected to disclose all serious adverse effects associated with their goods. The following information is needed for the initial report submission:


Companies must fill out the Council for International Medical Science (CIOMS)-I form and send it to HSA via online report or email to report adverse events. If any applicable additional information on the related AE is requested, follow-up reports must be submitted within 15 calendar days on any previously submitted AE report. A medicinal products manufacturer, importer or registrant must keep track of any adverse events (AEs) that occur as a result of using the product and provide those records to HSA for inspection when requested. The record must be held for at least 2 years after the medicinal product's expiration date.

Companies are required to submit a Risk Management Plan for their therapeutic products (mandatory for NDA-1 and biosimilar applications and on case to case basis as decided by Health Science Authority (HAS) for New Drug Application 2/3 (NDA2/3), Major Variation Application OR Generic Drug Application). In addition to RMP, the company has to submit a Periodic Benefit-Risk Evaluation Report (PBRER) to HAS.

HSA can guide a registrant of a therapeutic product to implement a risk management plan that includes, but is not limited to, the following to mitigate risks related to unsafe and ineffective use of therapeutic products:


In order to improve the benefit-risk balance of therapeutic goods, additional RMAs are needed for those with significant known or potential risks that involve an extra level of risk minimization. This could include, but are not limited to:


Causality assessment is done by HCPs using the following terms as per WHO UMC Causality Assessment Scale:



*TPB: Therapeutic Products Branch; VCB: Vigilance and Compliance Branch.*

#### **Table 2.**

*Summary of safety reporting requirements.*

*Introductory Chapter: Pharmacovigilance Regulatory Framework of Three Asian Countries… DOI: http://dx.doi.org/10.5772/intechopen.109194*


Data mining techniques are not disclosed by HSA on their official website. Details regarding possible local adverse effects of therapeutic drugs and medical products can be found in the HSA Adverse Case Online Database, which is based on documentation submitted to them by healthcare practitioners and businesses [6, 9, 10].

