The pharmaceutical industry is stringently regulated at the national and international level by governmental agencies, laws, directives, guidelines and recommendations which govern the manufacture, approval and marketing of drugs and other medicinal products.

Regulatory Affairs (RA) is the main contact at many pharmaceutical companies for coordinating these matters and therefore plays a key role in the success of a company.

The pharmaceutical industries in the USA, Great Britain and France has long been aware of the critical importance of regulatory affiars. Consequently, associations were long ago set up in these countries whose declared goal is to represent national interests in matters pertaining to the elaboration and implementation of new regulations and, to this end, ensure appropriate training and further training of qualified personnel.

The Society for Drug Regulatory Affairs is the first body in Germany whose purpose is to actively seek to improve and promote exchange between the industry, governmental authorities, ministries and regulatory institutes. As a competent mediator, the DGRA assumes a neutral position in these matters.

The second major function of the DGRA is to improve education in the field of drug regulatory affairs. Until now the only course of studies available was a programme in Cardiff leading to a Diploma of Regulatory affairs. Other further education course such as at the ECPM in Basel and the Witten-Herdecke University are not specifically set up with regulatory affairs in mind or do not lead to an internationally recognized degree.

The nature of regulatory affairs in daily practice has become more and more complex and multifarious in recent years. The obligation to adapt to EU legislature, the dictates of advancing globalization and the opening of new markets have all made it necessary for pharmaceutical companies to be intimately acquainted with national and international regulations governing the licensing of new drugs. This situation demands the targeted training of new employees and the further qualification of those already working in this area.

The Master of Drug Regulatory Affairs study programme is the only advanced degree offered in Germany with tutors drawn from from government bodies, institutes and pharmaceutical companies. The programme aims to explore the complex issues of regulatory affairs from various perspectives and makes them accessible to participants.

In the long term the DGRA's work will help to raise Germany's standing in the field of regulatory affairs and ensure that the national interests of the German pharmaceutical industry are better represented at the international level.