Pharmaceutical Regulatory Database of South American Countries

This database offers organized regulations intelligence information about the different countries within South America regarding their pharmaceutical product approval structure, the various drug regulatory agencies, and frameworks for granting marketing authorization. It collects the key parameters of drug regulations, including approval pathways, clinical trial contents and requirements, pharmacovigilance requirements, GMP standards, and international harmonization status into one cohesive comparative format. The purpose of this dataset is to help regulatory affairs professionals evaluate the feasibility of entering the market of a certain country, fulfil the specific compliance requirements for that specific country, as well as compare the regulatory level of maturity, transparency, and efficiency between jurisdictions.