Below buttons/boxes can be selected from the menu bars of the "Guide to Drug Regulatory Affairs":

Under "Structure/Contents" you will find all the chapters of the "Guide to Drug Regulatory Affairs" displayed in a tree structure. The chapter levels are displayed or hidden, respectively, by a click on the + symbol. All the levels are shown by a click on "Extend Chapter". Select a particular chapter by a click on the name of that chapter.

By a click on the respective arrow button below the selected chapterís title you can go to the next or previous chapter. Alternatively, you can click on the title of the respective chapter.

Sources and literature references in a chapter appear as consecutive numbers in blue colour, e.g. (1). By a click on a number the corresponding source or literature reference at the end of that particular chapter is displayed.

Sources and literature references shown in blue colour are linked to corresponding sites on the Internet.Sources and literature references shown in black colour are not linked.

Your last work:
If you click on this button, the screen content will be displayed that was displayed prior to the last logging off; e.g., if you had selected chapter A prior to logging off, a click will get you again to this chapter.

If you have selected no other setting, you are in the full text search mode. To obtain the  most appropriate search results it is recommended to put all or some of your terms between quotation marks, so the search will be on the entire phrase between quotes.

Click on "Advanced search" for changing the setting. Three different options are available:

Full text:
The entire content is searched for the entered search term(s).

The stored keywords of the chapters are searched for the entered search term(s).

The titles of the chapters are searched for the entered search term(s).

In addition, "Advanced search" enables you to restrict your search to the four main chapters of the Guide. Combinations are possible. E.g. only Part A or only Part B + C etc.

The three previous searches are displayed under "You searched for". By a click on this button you will get the particular results again.

The term(s) you searched for will appear highlighted in yellow in the chapterís text.

The search function is based on "phonetic search"; i.e., if you make a typing error or the term you have entered does not yield a result, alternatives will appear automatically in the "Did you mean" box. You can activate them by clicking on them.

General remarks:
To ensure optimum presentation quality a minimum screen resolution of 1024x768 pixels is required.

Questions or suggestions are always welcome at

Edited by

Brigitte Friese
Barbara Jentges
Usfeya Muazzam

With special contri-
butions by
Sven Harmsen,
Susanne Keitel, Chris
Oldenhof, Klaus
Olejniczak, Henrike
Potthast, Joachim A.
Schwarz, and Barbara

Special contributions
related to Switzer-
land by
Dorothee Heer and
Thomas A. Keller

With a foreword by
Susanne Keitel