Regulatory Strategies and Requirements for Registration of Innovator Drug Products Entering Latam Contries: Mexico, Peru, Equador and Chile

Abstract

The LATAM region i.e. Latin America region is considered as one of the most emerging markets in the pharmaceutical sector. The emerging market landscape provides ample opportunities for potential manufacturers to explore various pharmaceutical product categories such as innovator products, API, Generics, Dietary supplements, Diagnostics, Biological products, drug device combinations, and more into this region. According to statistical studies and reports, the pharmaceutical sector is projected to reach a revenue of USD $44.06 billion dollars in 2024. The major driven force behind increasing the demand are dynamic improvements in regulatory requirements, attraction of foreign manufacturers, giant pharmaceutical companies in terms of investments, efforts to achieve harmonization with established standards developed by major developed countries like World Health Organization, International Council for Harmonization of Technical Requirements of Pharmaceuticals for Human Use, United States Food & Drug Administration, European Medicines Agency, Medicines and Healthcare products Regulatory Agency, Therapeutic Goods Administration and many more. The government's proactive measures to improve the availability of high-quality pharmaceutical products also contribute to the enhancement of patient safety. This project primarily focuses on successfully navigating the regulatory requirements and potential challenges associated with initiating the registration procedures for Innovator drug products in countries such as Mexico, Peru, Ecuador, and Chile. Following Brazil, which is the most developed market in the LATAM region, the other countries in this region are classified as semi-regulated markets in the pharmaceutical sector. Despite being semi-regulated, these countries still have several deficiencies in the entire process, ranging from the registration of pharmaceutical products to their approval and commercialization in the market, lack of harmonization in eCTD dossier submission as still many countries in LATAM regions are demanded the paper based CTD submissions. This study also contributes to the understanding of the roles & responsibilities of regulatory authorities, their hierarchical structure, established guidance documents, and regulations in Mexico, Peru, Ecuador, and Chile. The project work begins with introduction to regulatory authorities and their established guidance documents along with regulatory requirements for medicinal products in Mexico, Peru, Ecuador, and Chile. The study provides a detailed analysis of the registration process which includes the steps involved in the online application for sanitary health registration, application fees for registration, the essential documents and data required by regulatory authorities, the procedures for document evaluation and approval, labeling requirements for medicinal products, the stability studies requirements, and the bioequivalence studies requirements, which are vary depending on the climatic zone condition of the countries. In conclusion, this thesis helps to understand the importance of navigating the complex regulatory environment in Mexico, Peru, Ecuador and Chile. By consistently evolving and making dynamic changes in regulatory policies and alignment with established xpglobal standards, these markets have the potential to become regulated pharmaceutical market like Brazil in the Latin American region.