Number of individuals needed to be treated for some specified period in order that one person would have one harmful event.

Medication errors with high potential for causing harm but did not (cancelled before reaching a patient or reaching the patient but who did not have

Regulatory authority within a country with the clinical and scientific expertise to collect, analyze and advise on drug safety.

ClinicalTrials.gov identifier – The unique identification code given to each clinical study upon registration at ClinicalTrials.gov. The format is “NCT” followed by an 8-digit number

A material or a composition that has not been previously used in an approved drug product in the US (i.e. not listed in FDA Inactive

In general, a submission that uses the eCTD folder structure and file naming conventions but does not include an XML backbone.

Node extensions are a way of providing extended organisational information in the eCTD. The node extension should be visualised as an extra heading in the

The vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. Source: New Drug

[EMA] A medicine authorised in a Member State in accordance with its national authorisation procedure. Source: Nationally Authorised Product

[EMA] A medicines regulatory authority in a European Union Member State. Source: National Competent Authority