Journal of Legal, Ethical and Regulatory Issues (Print ISSN: 1544-0036; Online ISSN: 1544-0044)


Regulatory Regime of Medicine in Malaysia

Author(s): Nurul Hayati Bohari, Abdul Samad Abdul Ghani

Different countries practise different regulatory regimes and structure of medicine. Thus, before any improvement is made on the regulation, people should first understand the regulatory regime of medicine with regard to medicine governance and regulation. Medicine governance is integral to health, economic, and socio-political sustainability. The management of medicine governance is complex, involving various regulations and requiring coordination across a range of professional bodies and relevant stakeholders so as to safeguard public interest. Therefore, this paper aims to identify the current regulatory regime of medicine regulatory enforcement in Malaysia as a developing country and analytically investigates it from the perspective of the responsive regulation theory. The method of analysis for this study involved library search of statutory laws or regulations, books, and annual reports produced by the relevant agencies. This study examined the regulatory regime, structure and classification of the regulatee groups in relation to the regulatory enforcement framework of Malaysia. Analytically, it was found that the current regulatory structure is inadequate where the composition of authorities is prone to represent public services and this significantly leads to inadequate representation and compliance from the regulatees. It is therefore suggested that future research examines the regulatory enforcement of medicine in Malaysia through the perspectives of the regulatees and the users to gain a more comprehensive understanding of the issue.

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