Saturday, 26 November 2022, 10:34 PM
Site: EUPATI Open Classroom
Course: EUPATI Open Classroom (EUPATI Open Classroom)
Glossary: Glossary
N

National Cancer Institute

Part of the US National Institutes of Health. http://www.cancer.gov/"

National Competent Authority

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.

National Health Service

British health care system. http://www.nhs.uk/"

National Human Genome Research Institute

Part of the US National Institutes of Health. https://www.genome.gov/"

National Institute for Biological Standards and Control

British agency for standardisation and control of biological medicines. http://www.nibsc.org/"

National Institutes of Health

US medical research agency. http://www.nih.gov/"

National Procedure (NP)

Independent national procedures are strictly limited to medicines which are to be authorised and marketed in only one Member State (MS). This procedure is nowadays rarely followed for new products.

National Research Ethics Service

National Research Ethics Service

New Drug Application

A New Drug Application (NDA) is a document submitted to the Food and Drug Administration (FDA) to request authorisation to market a medical product in the United States. The information in the NDA must allow the FDA to make the following judgements (quoted from FDA website):

- 'Whether the drug is safe and effective in its proposed use(s), and whether the benefits of the drug outweigh the risks
- Whether the drug's proposed labelling (package insert) is appropriate, and what it should contain.
- Whether the methods used in manufacturing the drug and the controls used to maintain the drug's quality are adequate to preserve the drug's identity, strength, quality, and purity.'

The NDA must include information about the medicine's ingredients, outcomes of the animal and clinical studies, how it behaves in the body, and how it is manufactured and packaged.

New Molecular Entity

New Molecular Entities (NMEs) are compounds that emerge from the process of medicine discovery, that are not a version or derivative of an existing, previously investigated/approved substance. They have promising activity against a particular target thought to be important in a disease, however, little is known about the efficacy, safety, toxicity, pharmacokinetics and metabolism in humans. A full development programme of non-clinical and clinical trials must be performed to evaluate the potential of an NCE to become a medicinal product.