Regulatory affairs play a crucial role in the pharmaceutical industry as they ensure the safety and efficacy of medicines for human use. The regulatory authorities of different countries have different requirements for the development, registration, and post-approval of pharmaceutical products. To ensure a consistent and harmonized approach to the regulatory affairs of pharmaceuticals, global organizations such as the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) have been established. The ICH brings together regulatory authorities and the pharmaceutical industry from around the world to develop and implement guidelines and standards that support the development of safe and effective medicines.1

The regulatory requirements of the countries under the MIST (Mexico, Indonesia, South Korea, and Turkey) and BRICS (Brazil, Russia, India, China, and South Africa) are different from those of ICH countries (Australia, Brazil, Canada, China, European Union, India, Japan, Russia, South Africa, South Korea, Singapore, Switzerland, Taiwan, United Kingdom, United States). These countries have their own unique regulations and guidelines, which may vary in terms of stringency, documentation requirements, and the length of the approval process. As a result, it is important for pharmaceutical companies to understand the specific requirements of each country to ensure a smooth and efficient regulatory process.2

In this study regulatory dossier requirements of MIST and BRICS countries with those of ICH countries are reviewed and compared. The comparison will provide an insight into the similarities and differences between the requirements of the different regions and help pharmaceutical companies to better understand the regulatory landscape in each country.

MIST countries have made significant progress in recent years in terms of regulatory reform and harmonization, but there is still a long way to go before they can be considered fully harmonized with ICH guidelines. In many MIST countries, there is still a lack of clarity and consistency in the regulatory requirements, which can result in longer approval times and higher costs for pharmaceutical companies.3

On the other hand, the BRICS countries have some of the largest pharmaceutical markets in the world and are of strategic importance to the pharmaceutical industry. In recent years, the BRICS countries have made significant efforts to improve their regulatory systems and harmonize their requirements with those of ICH. However, there are still significant differences between the regulations in each country, which can make it challenging for pharmaceutical companies to navigate the regulatory landscape. Understanding the specific requirements and challenges of each country can help companies to develop a successful regulatory strategy, reduce the risk of regulatory delays and costs, and ultimately bring safe and effective medicines to patients more quickly.4