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Advancement of modern biotechnology has wide impact on various industries. Modern biotechnology in the past has gone unregulated but the responsible use of biotechnology is the main focus worldwide. The most important living modified organisms (LMOs) regulatory framework is the Cartagena Protocol on Biosafety. This Protocol provides guidelines for the national legal framework. This paper aimed to perform comparative studies on Malaysia Biosafety Act 2007 and the Cartagena Protocol on Biosafety. The results show that while certain clauses in the Protocol are highly similar, and some proviso in the Biosafety Act 2007 arebroader in scope, and conversely, certain clauses of the Protocol are well reflected in the Biosafety Act 2007. It is submitted that in overall perspective, Biosafety Act 2007 is consistent with the Protocol. It is concluded that Malaysia biosafety regulation system satisfies this international requirement. However, with regards to enforcement of this Act, it remains unanswered, as no precedent has been reported. Interestingly, non-compliance of some proviso in the Biosafety Act 2007 will result in criminal penalty, and its impacts on the research and development in the biotechnology industry, commercial investment from abroad and domestic markets, and international trading of LMOs as food and feed, remain to be seen.