It is recognized worldwide that the regulation of medicines is part of the
essential function of public health and it is the primary State responsibility of every
country. It is a public policy that restricts private-sector activities in order to attain
social goals set by the State. It includes the legal, administrative and technical measures,
which governments take to ensure the safety, efficacy and quality of medicines, as
well as the relevance and accuracy of product information. Medicines Regulatory
Authorities (MRAs) are essential to ensure a strict regulation of the manufacture, trade and
use of medicines in order to protect public health. A legal framework is required
for the MRA, in order to guarantee independent testing and assessment of the quality, efficacy and safety of medicines as well as adequate staff and infrastructure...