When Grünenthal put Thalidomide on the market in West Germany in 1957, there was no legal public procedure in place to control or monitor the approval process of the new drug. West Germany was in fact the only country in the European Economic Community that didn’t have a national medical law.
No significant changes were made until 1976, when West-Germany passed a new medical law that for the first time introduced strict approval procedures for the introduction of new medications (coming into effect on January 1, 1978). Drug companies now needed to provide extensive documentation showing that their preparation was not only effective but also safe. On top of that, a new regulatory body was formed and equipped with the power to withdraw previously approved drugs.