Published online by Cambridge University Press: 23 December 2021
The construction of governance frameworks for new health technologies is a complex process for most countries, particularly for developing countries. They must grapple with ‘old’ structures and ways of doing things while striving to plant the seeds of the ‘new’, which will put them on a higher level to promote science as well as access to new drugs and treatments. To achieve these goals, international collaboration is a key element. Argentina issued a regulation for advanced therapy medicinal products at the end of 2018. This chapter describes the objectives and actors involved in that process. It focuses on how internal tensions regarding whether to regulate were solved, considering the regulatory harmonisation process promoted by the European Medicines Agency and the US Food and Drug Administration, and the self-regulatory diversification promoted by China and other countries. Special mention is made of the importance of identifying social values and constructing a vision to guide the exercise of ‘foresight’ in law, which resulted in the design and implementation of the new regulation and governance of the system.