Promoting Collaboration of Regulators and Patients in Improving Drug Safety and Regulatory Decision Making

Pharmacovigilance involves a continuous process of evaluating, monitoring and communicating the safety profile of a medicine throughout its life cycle. This process involves a range of stakeholders, including national regulatory authorities, industry, health organisations, healthcare providers and patients. Although patients are the end users of medicines and experts in their medical conditions, patient involvement is still nascent in the Asia-Pacific region. While there are positive examples and encouraging trends, several key challenges currently hinder systemic patient involvement in drug safety and regulatory decision making. Systemic issues such as a lack of formalised frameworks or platforms, underdeveloped communication and information exchange channels, and paternalistic health systems constrain greater patient involvement and collaborative regulator-patient activities. Addressing these challenges will greatly advance collaboration among regulators, patients, and patient advocates to enhance drug safety and regulatory decision making.