Internationale Regulierung der Gentechnik. Praktische Erfahrungen in Japan, den USA und Europa

The study analyses practical experiences with the respective national laws and regulations for containded use and deliberate release of genetic engineered organisms in the USA, Japan, France, Great Britain, the Netherlands and Germany. For each country the approval procedures were investigated with respect to institutions involved, number of applications received and approvals given/refused, time and manpower requirements until approval of application is attained, costs, confidentiality and involvement of the public, alignment of regulation to present state of the art in science and technology, special problems and events. From the international experiences it can be concluded that the approval procedures will be most efficient if the following requirements are met: flexible interpretation of law or regulation, quick alignment of regulation to the dynamic development in science and technology, intensive cooperation and communication between applicant and competent authority, making hel p (forms, computer programmes, examples etc.) available to the applicants.