About Vigilance and Compliance Branch
The Vigilance and Compliance Branch functions to manage and address any potential safety and quality issues that could arise from the use of health products marketed in Singapore, including western medicines, medical devices, Chinese Proprietary Medicines and cosmetic products. This is achieved through various post-market surveillance activities that maintain vigilance for safety issues and ensure product registrants comply with their responsibilities.
The purpose of post market surveillance is to ensure the benefits of health products continue to outweigh the potential risks after the product has been approved for use. The process of post market surveillance involves the process of monitoring and detecting safety issues as well as evaluating and managing risks. This involves identifying issues that could affect the safety, quality and efficacy of health products and communicating the relevant information to the relevant stakeholders, including health professionals and the public in order to address any potential risks.
Before a health product is licensed, information on its safety is limited. For medicines, the information from its clinical trial may be limited by the number and type of patients, as well as duration of the trial. As such, adverse drug reactions that are rare may not be detected prior to the medicine being licensed. In addition, little information is available on the possible drug interactions that the medicine may have with other products. With the increasing use of complementary health products, there is a potential risk for interactions between these products and patients’ own western medicine.
To assist in the monitoring and detection process, the Vigilance and Compliance Branch has in place an adverse event monitoring programme which consists of a network of local healthcare professionals, who actively report all possible adverse events to HSA. With technological developments, multiple channels for submitting adverse event reports have since been established, including by post, email, fax, or through HSA's web-based reporting portal. Adverse event may also be reported through the Critical Medication Information Store (CMIS), as part of the public hospitals’ electronic medical record initiative.
The evolution: Pharmacovigilance Branch to Vigilance and Compliance Branch
The Vigilance and Compliance Branch, initially named the Adverse Drug Reaction Monitoring Unit, was formed in 1993. Singapore joined the World Health Organisation (WHO) in 1994 as the 40th member of the WHO International Drug Monitoring Programme for international collaboration on drug safety. With the expansion in its area of surveillance to include cosmetics, complementary health products, vaccines and advanced therapeutic products, the Branch was renamed the Vigilance and Compliance Branch in 2014. Despite overseeing a wider range of health products, the underlying principles and fundamentals behind safety monitoring, risk management and risk communication remain the same and are applied to the various health products.
Activities of the Vigilance and Compliance Branch
The Vigilance and Compliance Branch consists of five core functions that conduct various post-market surveillance related activities;
- Adverse event monitoring
- Risk assessment and management
- Risk communication and regulatory research
- Environmental scanning for potential issues relating to health products’ safety, quality and efficacy
- Medical advertisement and compliance monitoring.
Adverse Event Management Unit (AEMU)
The Adverse Event Management Unit reviews adverse events related to the use of health products.
Health product related adverse events
Adverse event reports related to health products are collected and documented into HSA’s Adverse Event database for further analysis and trending to detect signals of potential safety concerns. As a member of the WHO International Drug Monitoring Programme, anonymised local AE reports are also submitted to the Uppsala Monitoring Centre (UMC) in Sweden, to be included into the global AE database. This international collaboration aims to facilitate better signal detection through the aggregation of reports from all over the world.
Common Vigilance Unit (CVU)
The Common Vigilance Unit conducts environmental scanning activities for information relating to issues that could potentially affect health products that are marketed in Singapore. In addition to its environment scanning activities, the CVU co-ordinates the measures to be taken by both the pre- and post- market divisions in response to any potential safety, quality or efficacy issues detected through environmental scanning.
Product Risk Management Unit (PRMU)
The Product Risk Management Unit assesses possible safety issues with medicines that are reported outside of Singapore. Benefit-risk assessments are conducted to determine if the issues are relevant in the context of local medical practice and whether the product continues to remain suitable for use. If necessary, risk mitigation strategies are implemented to ensure the benefits of medicines continue to outweigh the possible risks. In addition to its assessment of international safety signals, the PRMU also evaluates the potential risk of health products sold locally and were found to have failed to meet the regulatory requirements of HSA for quality and safety.
Risk Communications and Regulatory Research Unit (RCRRU)
The Risk Comms and Regulatory Research Unit communicates important information relating to safety issues and regulatory decisions to stakeholders, including healthcare professional and the public. The information is communicated through various channels including press releases, the Adverse Drug Reaction News Bulletin, Dear Healthcare Professionals Letters, Product Safety Alerts and training events.
In addition to its role as a communicator, RCRRU conducts research studies in collaboration with local hospitals to investigate possible links between genetics and the occurrence of certain adverse drug reactions, such as serious skin reactions and drug induced liver injuries.
Medical Advertisements and Compliance Monitoring Unit (MACMU)
The objective of advertisement control of health and medicinal products is to ensure that accurate and factual information about the products is disseminated and to ensure that the advertisements and sales promotion activities do not mislead consumers or induce unnecessary purchase or consumption of the products.
The Medical Advertisements and Compliance Monitoring Unit reviews and monitors the advertisements of health and medicinal products for compliance to HSA’s regulatory requirements. For more information on medical advertisements and sales promotions, please visit http://www.hsa.gov.sg/content/hsa/en/Health_Products_Regulation/
In addition to the review and monitoring of advertisements, the MACMU conducts compliance monitoring and follow-up for various product groups such as compliance to dealer licensing requirements and post-market licence conditions, to ensure that the product registrants comply with their responsibilities and that the health and medicinal products meet the specifications that were registered with HSA.
If you need further information, please contact the Vigilance and Compliance Branch.