Investigating the pathways for development and registration of biologics in MIST countries

Year 2025, Volume: 29 Issue: 6, 2287 - 2297, 02.11.2025

Nidhi Kansara Hiral Dave

https://doi.org/10.12991/jrespharm.1797769

Abstract

The MIST countries refer to a group of emerging markets that are expected to experience significant economic growth and development. The acronym MIST stands for Mexico, Indonesia, South Korea and Turkey. The development and registration of biologics are overseen in Mexico by Federal Commission for Protection against Sanitary Risk, Indonesia by National Agency of Drug and Food Control, respectively, South Korea by Ministry of Food and Drug Safety while in Turkey these responsibilities fall under Turkish Medicines and Medical Devices Agency. Mexico and Indonesia, with evolving regulations, present strong investment opportunities, while South Korea and Turkey align with global standards. These countries are working to align their standards with international guidelines to facilitate global market access and ensure the high quality of biologics. This article provides a comprehensive overview on regulatory requirements for development and registration process of biologics in MIST countries. After studying the guidelines of all four countries comprehensive pathways for development and registration of biologics. The MIST countries are emerging markets advancing in biologics development and registration. Each has distinct regulatory frameworks tailored to encourage biologics and biosimilars, driven by unmet medical needs and chronic disease prevalence. Collectively, these countries are poised to shape the future of biologics in emerging markets.

Keywords

Biologics , Indonesia , Mexico , MIST countries , Registration , Regulatory authority , South Korea , Turkey

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