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The broad and multifaceted problem of global health law and global health governance has been attracting increasing attention in the last few decades. The global community has failed to establish international legal regime that deals comprehensively with the'technological revolution'. The latter has posed complex questions to regions of the world with widely differing cultural perspectives. At the same time, an increasing number of governmental and non-state actors have become significantly involved in the sector. They use legal, political, and other forms of decision-making that result in regulatory instruments of contrasting normative status. Law created in this heterogeneous environment has been said to be fragmented, inconsistent, and exacerbating uncertainties. Therefore, claims have been made that a centralised and institutionalised system would help address the problems of transparency, legitimacy and efficiency. Nevertheless, little scholarly consideration is paid to the normative status of international biomedical law. This paper explores whether formalisation and" constitutionalisation" of biomedical law are indeed inevitable for its establishment as a separate regulatory regime. It does so by analysing the proliferation of biomedical law in light of two the theory of fragmentation and the theory of global legal pluralism. Investigating the problem in this way helps determine the theoretical framework and methodology of future studies of biomedical law at the international level. This in turn should help its future development in a more consistent and harmonised manner.