Category Archives: 2015

Obtain Free Access to a Vital Regulatory Resource for Pharmaceutical and Other Professionals

The EDQM (or in full, the European Directorate for the Quality of Medicines & HealthCare) maintains the Standard Terms Database, which holds the official European list of terms and definitions for describing Pharmaceutical Dose Forms, Routes and Methods of Administration, Containers, Closures and Administration Devices.

Standard Terms are to be used in the Marketing Authorisation Application, the Summary of Product Characteristics (SmPC), and in labelling and electronic communications.

They are currently provided in the Database in 33 languages from around the world: Albanian, Bosnian, Bulgarian, Chinese, Croatian, Czech, Danish, Dutch, English, Estonian, Finnish, French, German, Greek, Hungarian, Icelandic, Italian, Kazakh, Latvian, Lithuanian, Macedonian, Maltese, Norwegian, Polish, Portuguese, Romanian, Serbian, Slovak, Slovene, Spanish, Swedish, Turkish and Ukrainian.

The Database content includes combinations of terms, for example to describe where two or more items are packaged together, or where a pharmaceutical dose form and a container are described using a single term. The Database also contains patient-friendly terms, which are generally shorter terms that, where justified and authorised by the competent authority, may be used on certain labels where space is limited.

Originally a printed publication, from 1 January 2016, all approved Standard Terms and their definitions and translations can be found online in the Standard Terms database maintained by EDQM.

The database requires a registration, but is open and free for all users. The registration takes place on the EQDM website. If you do not already have an account you can set one up for free. Start by searching for or use your browser to search for “EDQM HelpDesk Publications Registration”.

Once you are registered select the free access link for the Standard Terms Database, complete details as necessary and your password will be emailed to you by the EDQM.


An interesting legal result regarding off-label use; one to watch

Article from Reuters

A U.S. judge on Friday barred the U.S. Food and Drug Administration from stopping Irish drugmaker Amarin Corp from promoting its fish oil drug for off-label uses, saying the company is protected by the First Amendment.
The pharmaceutical industry has been watching this case because it is one of the first to raise a First Amendment argument in defense of promoting drugs for uses the FDA has not approved. Shares of Amarin rose 12 percent on Nasdaq.
The order by U.S. District Judge Paul Engelmayer in Manhattan means Amarin can promote its Vascepa pill to doctors for off-label use as long as it does so truthfully.