Medicines are widely tested worldwide. There are dozens of laboratories in Europe that form a network of official control laboratories. They test many different medicines every year.
Medicines
The pharmaceuticals market is a European market. Medicines used by Dutch patients are just as used in other European countries. In the report following the possible paracetamol contamination you can read more about this here.
Drug research
Research into the quality of medicines starts with the companies. They test their medicines. And if something is not right, a drug will not be marketed. The inspection services come to the companies to check whether companies are carrying out these checks properly, and whether the companies intervene properly if something is wrong from the analyzes of a medicine.
Pollution
It is good to understand that detecting a pollution is not easy. A medicine cannot simply be put into a device, which then analyzes what it contains. A specific pollution must be sought. This is only possible if you know exactly which pollutants can arise.
It was not known until 2018 that NDMA could develop during the production of sartans, ranitidine and metformin. Since the discovery of NDMA in valsartan and other sartans, all kinds of medicines have been tested worldwide for the presence of NDMA. In this search, the contaminants in ranitidine and metformin were also discovered.
Network of laboratories
Quality assurance does not stop with the manufacturers. In Europe there are dozens of laboratories such as the RIVM, together they form the network of official control laboratories.
RIVM has its own responsibility in this. Within this network, many hundreds of products are sampled every year and tested whether they meet the quality requirements.
The IGJ receives reports of all these studies, both from RIVM and from the other laboratories. The picture that these reports provide has been consistent for years: the vast majority of tested medicines fully meet the quality requirements.
In numbers: approximately 1,400 medicines were tested in 2019 (of which more than 200 veterinary medicines). 96 percent of them met the quality specifications. (Source: EDQM annual report 2019, who coordinates this program)
System works
These annually recurring studies into the quality of medicines by independent official laboratories, and the consistent picture that these studies provide, give the IGJ the confidence that the system of quality assurance of medicines is working.
That does not mean that nothing never goes wrong. And if so, then we can intervene. But this does mean that the confidence we have in the quality of medicines used by Dutch patients is justified.
On Thursday evening, September 10, the television program Zembla paid attention to the topic of medicine contamination. In this broadcast an image was sketched that almost no medicines are tested to see whether they meet the quality requirements. The inspectorate does not consider this image justified.
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