FDA.

The Food and Drug Administration is responsible for protecting the public health by ensuring
the safety, efficacy, and security of human and veterinary drugs, biological products, and
medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products
that emit radiation.
FDA also has responsibility for regulating the manufacturing, marketing, and distribution of
tobacco products to protect the public health and to reduce tobacco use by minors.
FDA is responsible for advancing the public health by helping to speed innovations that make
medical products more effective, safer, and more affordable and by helping the public get the
accurate, science-based information they need to use medical products and foods to maintain
and improve their health.
FDA also plays a significant role in the Nation's counterterrorism capability. FDA fulfills this
responsibility by ensuring the security of the food supply and by fostering development of
medical products to respond to deliberate and naturally emerging public health threats.

EMA

EMA is a decentralised agency of the European Union (EU), located in Amsterdam. It began operating in
1995. The Agency is responsible for the scientific evaluation, supervision and safety monitoring of
medicines developed by pharmaceutical companies for use in the EU. EMA protects public and animal
health in the EU Member States, as well as the countries of the European Economic Area (EEA), by
ensuring that all medicines available on the EU market are safe, effective and of high quality. 1. What we
do The mission of the EMA is to foster scientific excellence in the evaluation and supervision of
medicines, for the benefit of public and animal health in the EU. Facilitate development and access to
medicines. EMA is committed to enabling timely patient access to new medicines, and plays a vital role
in supporting medicine development for the benefit of patients. The Agency uses a wide range of
regulatory mechanisms to achieve these aims, which are continuously reviewed and improved. For more
information, see: • support for early access; • scientific advice and protocol assistance; • paediatric
procedures; • scientific support for advanced-therapy medicines; • orphan designation of medicines for
rare diseases; • scientific guidelines on requirements for the quality, safety and efficacy testing of
medicines; • the Innovation Task Force, a forum for early dialogue with applicants. EMA also plays a role
in supporting research and innovation in the pharmaceutical sector and promotes innovation and
development of new medicines by European micro-, small- and mediumsized-enterprises. Who does
initial research on medicines? The initial research on medicines is usually done by pharmaceutical and
biotechnology companies – some big companies develop many medicines, while others are small
companies who may only be researching one or two. Doctors and academics also perform research, and
may get together to research either new medicines or new uses of old medicines. Such researchers,
either in public institutions or private companies, investigate vast numbers of substances for their
potential as medicines each year. However, only a small proportion of the compounds investigated will
ever be promising enough to progress to further development Did you know...? Developers of
innovative treatments can discuss the scientific, legal and regulatory aspects of their medicine with EMA
early in the development through the Innovation Task Force. In 2018, 9 of 22 such requests for early
discussions came from university-based or academic groups. How are potential new medicines tested?
Potential new medicines are tested first in the laboratory and then in human vol.