PHARMA REGULATION IN BRAZIL: A REGULATORY VIEW
V. THOYAJAKSHA
Regulatory Affairs Group, Department of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Mysuru - 570015, Karnataka, India.
K. S. DEEKSHA
Regulatory Affairs Group, Department of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Mysuru - 570015, Karnataka, India.
V. BALAMURALIDHARA *
Regulatory Affairs Group, Department of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Mysuru - 570015, Karnataka, India.
M. P. GOWRAV
Regulatory Affairs Group, Department of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Mysuru - 570015, Karnataka, India.
D. THANUSH
Regulatory Affairs Group, Department of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Mysuru - 570015, Karnataka, India.
*Author to whom correspondence should be addressed.
Abstract
Brazil, which has the most people of any country in South America, just overtook India to become the country with the second-largest pharmaceutical sector in the entire globe. The National Health Surveillance Agency of Brazil, also known as Agência Nacional de Vigilancia Sanitária (ANVISA), was established in 1999 with the primary goal of protecting and enhancing Brazilian public health surveillance of pharmaceutical products and services. Its acronym, ANVISA, is an acronym for the name of the agency. The Brazilian Health Surveillance Agency, also known as ANVISA and housed inside the Ministry of Health, is responsible for supplying the pharmaceutical sectors with the necessary regulatory procedures and documentation. ANVISA's mission is to achieve public legitimacy as a key component of the Brazilian Unified Health System by developing a health monitoring organisation that possesses the agility, modernity, and transparency necessary to act as a national and international benchmark. This goal will be accomplished by developing a health monitoring organisation that possesses these characteristics. ANVISA is in charge of managing the registration and licencing processes for pharmaceutical laboratories and other types of businesses involved in the production of pharmaceuticals. The purpose of this research is to acquire an in-depth comprehension of the requirements imposed by the Ministry of Health of Brazil on pharmaceuticals, biological products, medical devices, and clinical trials.
Keywords: Registration, drugs, medical devices, clinical trial, ANVISA, regulatory requirements