It was in 1969 that side effects ought to be reported to the ‘Institut für Arzneimittelwesen’ (IfAr) in Berlin. Therefore, a special blank was provided. The reports arriving were collected and evaluated by the IfAr. Although the number of incoming reports had initially been increasing, the overall willingness to report ADR must be characterized as relatively moderate. As a consequence, public appeals were placed in several medical and pharmaceutical journals in order to call attention to this problem. Nevertheless, these and other measures such as an obligation to report, which was established in 1981, did not succeed. Under the circumstances, decisions on withdrawal of drugs or other restrictive measures were in many cases made with consideration of international experience.

A crucial board deliberating on adverse drug reactions was the ‘Zentraler Gutachterausschuss für Arzneimittelverkehr’ (ZGA) which was already officially legitimized in 1949 when a directive came into force regulating the circulation of medicinal products. Members of the ZGA were clinicians, pharmacologists, pharmacists and also representatives from industry. Among other things, their essential function consisted in counselling the Ministry of Health regarding decisions on the registration or deletion of drugs.

In the second half of the 1970ies occurrences of lactic acidosis increased on the therapy with biguanides, buformin and phenformin in particular. This lead to discussions about the safety of these kind of drugs – also in the GDR where reports of lactic acidosis have not existed until October 1977. For instance considering this affair, the ZGA was asked to make a statement. On the contrary, Arupex liquidum®, a drug against head louses, is an example for a modified benefit-risk assessment based on ADR reports having arrived at the IfAr.