For the pharmaceutical sector, key topics identified by IGZ include:

  • IGZ gives priority to inspections concerning recent market introductions of new medicinal products, by assessing companies' marketing plans;
  • IGZ visits pharmaceutical industry-sponsored conferences and trainings;
  • IGZ starts conversations with management of pharmaceutical companies concerning companies' compliance procedures and the way they ensure compliance with pharmaceutical advertising rules (which include rules on financial interactions with healthcare professionals and healthcare organisations);
  • Increase in supply shortage of medicinal products;
  • Increase in named patient supply of medicinal products for which no marketing authorisation has been granted;
  • Continuation, under strict conditions, of IGZ's policy to not take enforcement actions against collegial delivery of pharmacy compounded medicinal products from one pharmacy to another, despite this being contrary to EU pharmaceutical law; and
  • Increase in pharmacy compounding in hospital pharmacies and higher intensity of inspections related to GMP in hospital pharmacies.
For the medical devices sector, key topics identified by IGZ include:
  • Re-inspection of all notified bodies in the EU during the next 3 years, by the Joint Assessment Team consisting of inspectors from the EU Member States together with the European Commission;
  • Disclosure of Field Safety Corrective Actions;
  • IGZ visits Authorised Representatives established in the Netherlands that represent manufacturers of medical devices established outside of the EU;
  • IGZ will research the risks of 3D-printing; and
  • Continuous focus on e-Health, including information exchange and data security.
Other, more general topics include:
  • As of 2017, IGZ will publish more inspection reports due to a legislative change that was adopted in 2016.
  • In 2017, IGZ will merge with the Inspectorate for Youth Care (Inspectie voor de Jeugdzorg).
  • IGZ has identified 4 general risk themes for its inspection and enforcement activities in 2017: (i) network healthcare in a changing health sector, (ii) good governance, (iii) medication safety and (iv) malfunctioning healthcare professionals.