National Competent Authority [NCA]

A National Competent Authority – or regulatory authority – has the power to grant marketing authorisations for medicinal products in its territory.

National competent authorities are organisations that have the legally delegated or invested authority, or power to perform a designated function, normally monitoring compliance with the national statutes and regulations.

Efficacy and safety of medicines
Medicines must balance efficacy and safety, benefits and risks. The efficacy and safety of a medicinal product are tested thoroughly during its development, and carefully monitored after the product enters the market.
Research Ethics Committees (REC)
Research Ethics Committees (RECs) evaluate the ethical acceptability of research before participants can be enrolled in a study. RECs are highly regulated, neutral bodies which operate according to standard operating procedures in order to protect the health and safety of human participants of clinical trials, among other things.
Making a medicine. Step 7: Phase II – Proof of concept
Phase II clinical studies, or proof of concept studies, begin to test the effect of a medicine on the target disease in humans. These studies are usually run as double-blinded, randomised studies in multiple sites.
Making a medicine. Step 6: Phase I – Proof of mechanism
Phase I clinical studies, or proof of mechanism studies, test the safety of a medicine in humans. Usually, these studies are carried out in healthy human volunteers.
Marketing authorisation
Before a medicinal product can be marketed and sold, a marketing authorisation must be obtained from the relevent National Competent Authorities. The marketing authorisation application process can take one of two paths - the decentralised procedure, or the centralised procedure. In some cases in Europe, the centralised procedure is mandatory.

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National Competent Authority [NCA]

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