Work ongoing on election-delayed DAMA:
This article was originally published in Clinica
Executive Summary
The German competent authority, BfArM, which oversees pharmaceutical product registration and materio- and pharmacovigilance, has been restructured in what is seen as the first phase of changes ahead of its eventual transformation into an agency, called DAMA. The new German pharmaceutical and medical products agency, whose passage into law has, however, been delayed by the SPD's early election call, will have a high level of autonomy and a modern management structure with which to set policy for the E23bn pharmaceutical and E20bn medical technology sectors, said temporary institute head Professor Reinhard Kurth. A law enacting DAMA will have to await the next legislative period.