Duration of clinical development (from initiation of studies in humans to receipt of Marketing Authorisation), subdivided into clinical trial and regulatory approval periods by the date of Marketing Authorisation Application.
5 This period was further subdivided by the date of Marketing Authorisation Application (MAA, regulatory submission or 'filing') into periods representing clinical trials (prior to filing) and subsequent regulatory approval.
Table 1 summarises when the products were originally licensed, the date of the latest authorisation and the date of the most recent substantive change to the SPC.
To avoid potential bias due to time-related differences in the probability of getting authorisation, for each authorised product, a random sample of up to two designated products from the same time period (120 days before to 120 days after) as the designation date of the authorised product was selected.
The follow-up period would be defined from the authorisation date of the specialty licence until the date of failure or censoring.
For each prescription, the following information is available at the regional level: patient code (which is anonymised before any subsequent use), date of prescription, drug substance, marketing authorisation code (indicating the specific tiotropium formulation, ie, Handihaler or Respimat), number of packages.
In this way it has parallels with the EMA's adaptive licensing pilot, but this EU-wide initialsoe also has the potential to bring forward the date of a drugs initial Marketing Authorisation, allowing first approval in highly selected patient populations based on more limited initial clinical studies.
For each product, the following information was abstracted: generic name, brand name, manufacturer, indication, date of notice of compliance (NOC marketing authorisation), type of review (priority or standard) and type of product (traditional or biological).
The Lithuanian border guards would accept our letter of authorisation.
The latter required a greater degree of authorisation than a shotgun licence, he said.
Independent watchdog Monitor has ruled James Paget University Hospitals NHS Foundation Trust at Gorleston now meets its terms of authorisation.
