In last years, Latin America has become one of the regions which many pharmaceutical industries are focusing their projects, considering the population, the requirements, the economy.

However, Latin America is made up of several countries and, regarding the registration of medicinal products, these countries do not follow the same legislation and do not have the same requirements and submission processes.

During this webinar with Milena Barrozo and Alessandra Rolim, Regulatory Affairs Consultants at Vita Regulatory Affairs Consulting, we will be discussing the main requirements for Marketing Authorization of Medicinal Products in some countries from this region. We will provide viewers with an understanding of these general requirements, along with practical advice.

1. Introduction to Latin America

• Countries to be covered during the training and general characteristics 

• Regulation development in the region: diverse regulations, constant updates 

• National Regulatory Authorities (NRA) 

• PAHO Reference NRAs 

• NRAs in global harmonization initiatives (ICH, ICMRA, PIC/s) 

2. Brazil

3. Colombia

4. México

5. Argentina

6. Peru

(For each country, a general approach regarding Health Authority, Legal Framework, GMP Certifications, Marketing Authorization, General Pharmaceutical Evaluation Requirements).