2nd Quarterly Update 2011

Radiopharmaceuticals not very often appear in these updates but this quarter they did as we performed a GMP-audit in a nuclear pharmacy to establish their compliance with the GMP-Z guidelines. GMP-Z is a typical Dutch “invention” and combines the regular EU-GMP rules with requirements for aseptic compounding in hospital pharmacies. Z stands for Ziekenhuis meaning hospital. Such aseptic compounding in hospital includes the preparation of oncolytics, total parenteral nutrition solutions as well as radiopharmaceutical preparations. Radiopharmaceutical preparations usually include labeling procedures for small molecules, peptides or cells and are being used on nuclear medicine departments in hospitals. Interestingly, in the early eighties of the last century nuclear medicine was expected to become extinct for environmental reasons but went through a remarkably recovery due to the introduction of various short-lived new isotopes for positron emission technology like 18F, or various rare metals for labeling of proteins like 177Lu.

More extinction in the pharmaceutical domain is expected when it comes to parallel import. Once price harmonization between all European member states has become reality, this phenomenon will no longer be a viable business model. But that might still take a number of decades if it ever will occur. And so we supported a Dutch parallel importing company and guided it through an inspectorate audit and the preceding preparation with a favorable outcome. On the fly we introduced and trained a new Qualified Person for this company, so they now are fully reorganized and back on their feet again to survive those decades to come.

OTC companies on the other hand will never get extinct but will presumably have a prosperous future due to the  continuous flow of OTC switches, i.e. Rx medicines getting reclassified as OTC medicines if they have obtained a track record demonstrating safety. This quarter we got requests from two such companies for regulatory management of their complete portfolio. This includes not only the classical regulatory life cycle management such as variations and renewals but it also includes pharmacovigilance responsibilities as OTC companies only recently have appeared on the radar of pharmacovigilance Inspectorates.