Introduction to Marketing Authorization Regulations in Latin America

Mar. 16th, 2023

Milena Barrozo / Alessandra Rolim


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.


  • 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)
  • Brazil
  • Colombia
  • México
  • Argentina
  • Peru

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


Date Time (GMT +8) World Clock Language
2023-03-16 21:00 ~ 22:00 Porto Alegre: 10:00-11:00
Lisbon: 13:00-14:00
London: 13:00-14:00
New York: 9:00-10:00


Milena Barrozo

Regulatory Affairs Consultant, Co-founder, and Director at Vita Regulatory Affairs Consulting

Milena is based in Brazil. Since 2007 is working in the pharmaceutical industry field such as quality assurance, quality control, and, mainly, regulatory affairs. National and international experience. She has been responsible for the CTD training and pilot projects in several Brazilian Pharmaceutical Industries, as well as training and projects in Europe. Industrial Pharmacist with MBA degree in Business Management; post-graduation in Regulatory Affairs; Personal and Professional Coach; Master’s degree in Regulation and Evaluation of Medicines and Health Products for Europe.

Alessandra Rolim

Regulatory Affairs Consultant at Vita Regulatory Affairs Consulting

Alessandra is based in Brazil. Since 2004, Alessandra has been working in regulatory affairs, for pharmaceutical and cosmetic industries, in Brazil and other Latin American countries, responsible for marketing authorization and post-approval strategies and processes. She holds degrees as a Pharmacist and is in a specialization course in Business Administration.

Contact Us

If you have any questions about this webinar, please feel free to contact us:

Tel: +86 (0)571 8710 3829