About Us

ECV Editio Cantor Verlag was founded in 1948 and is a specialised publishing house situated in Southern Germany. It publishes professional journals and books dealing with all aspects of research, development, manufacturing, marketing approval and distribution of drugs.

Its professional journals and an increasing number of its professional books are available both in print and electronic versions. The publisher's products have a worldwide distribution.

ECV places a high value on reputation and quality. It maintains a network of contacts with experts in industry, authorities, associations, universities and colleges. Resident correspondents at home and abroad as well as experts who are members of the boards of its journals complete the network of specialist advisers.

Guide to Drug Regulatory Affairs

In 1998 ECV published in German it's 'Handbuch der EU-Zulassung' (Manual of Marketing Authorisation in the EU) - which was reprinted in 2002.

The idea of publishing a 'Guide to Drug Regulatory Affairs' arose from the demand for an English edition and because of the increasing complexity of the regulatory environment for placing and maintaining a medicinal product on the market. Over the following years the idea grew into a more extensive project than originally planned with the enthusiastic support of new editors. The result is a new multi-media information platform in the form of a print and online version.

The three editors are specialists in legal and regulatory affairs concerning marketing authorization for drugs in the European Union. They have cooperated with other experts in order to deal authoritatively with topics such as marketing authorization in Switzerland and highly specialized areas such as the implementation of clinical studies or aspects of pharmacovigilance.

The 'Guide to Drug Regulatory Affairs' is designed as a platform for everyday practice, which not only makes routine work easier, but also keeps the user well informed about changes in the legal and regulatory environment.


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