2nd Quarterly Update 2009

This quarter two USA companies called for our support to initiate a clinical study in the Netherlands. While CRO’s usually are well-equipped to design and finalize the trial protocols, creating the appropriate supply chain to all investigational centers is quite a different story. Such a supply chain from the USA to EU-investigational centers will have to include an EU-import license for investigational products as well as a QP-release of the batches to be used in the clinical study. While these issues already might discourage you to consider starting a trial, things get even worse when opioids are involved for which additional regulations are applicable. Fortunately, we know the way out of this regulatory labyrinth.

Yet another USA company called upon us to take over the compliance responsibilities for their promotional materials. This still is an issue of medicinal products which exclusively is regulated by the national authorities of the EU member states. In addition, at least in the Netherlands, promotional activities regarding medicinal products (and including gifts and hospitalities towards prescribers) have a high profile and are frequently subject to newspaper articles, parliamentary debates as well as protests from patient/consumer organizations. In addition, major changes to the current regulations regarding such promotional activities are in preparation in our country. Easy to understand that an increasing number of foreign companies gratefully outsource these compliance checks to us.

Occasionally we are asked to produce non-clinical or clinical overviews to be included in EU- of non-EU marketing authorization applications and this quarter we did produce one for a French company. This particular product contained an antibiotic developed in the late forties. Fascinating it is, to describe the investigational routes which were followed in those days for active ingredients. A compound developed in 1949, clinically applied in 1950 and the results published in 1951 in a landmark article which still holds as a pivotal study in 2009! And in the absence of a Pediatric Investigational Programs or a Risk Management Plan the authors easily injected the compound in a 2-months old baby, intrathecally……..

It made me think, how many of those valuable compounds originating from the forties or fifties from the late century we would have available on the market if current regulations applied in those days? Fat chance we would have the corticosteroids around…….