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Biosimilars in Chile
The regulatory body in charge of approving
medicines is the National Medicines Agency (ANAMED), which is part of the Public Health Institute of Chile (ISP), under the Ministry of Health.

Biosimilars in Latin America
The regulations for biosimilars vary
considerably from one country to
another, but in general the trend is an
increase in the regulatory standards for their health registration.

Colombian Health System
The main objective is to regulate the essential public health service and create conditions of access for the entire resident population of the country, at all levels of care.

Biosimilars in Mexico
The regulatory body for the approval of
medicines in Mexico is the Federal Commission for Protection Against Health Risks (COFEPRIS)

Oppotunities for orphan drugs in Latin America
There are ample opportunities for the entry of orphan drugs into the region. The size of the Latin American orphan drug market was USD 14.17 billion in 2021 and it is estimated that it will increase by 7.38% by 2026. Based on the type of drug, the biological sector dominates the orphan drug market for Latin America

Health System in Ecuador
The Ministry of Public Health (MSP) offers health care services to the entire population.