English Abstract Whenever a drug is approved for marketing, this does
not ensure that a drug will be safe in subsequent prescribing practice: no
effective drug is totally safe. The approval merely means that, at the time
of approval, no hazards unacceptable to the regulatory agency have been
identified. Because of the inherent shortcomings of preapproval research,
postmarketing surveillance (PMS) is crucial for providing additional
information that cannot realistically be collected before approval of the
drug. Only by implementing a responsive and responsible PMS system can
serious adverse drug events and unknown beneficial effects, if they exist,
be detected in a timely fashion. Before setting up new PMS systems, one
must have insight into the present PMS activities in the Netherlands and the
interests of the parties involved. These aspects are discussed in this
report. From this inventory it has become clear that there is no sole
system, rather different activities are complementary to each other in
providing the information needed by the different parties involved. The
report concludes with proposals for the organizational structures of future
PMS activities.