The decision will see the European Medicines Agency (EMA) supervise the Chinese company’s manufacturing process to monitor the implementation of corrective measures.
According to the agency, this would see it monitor the company “on a regular basis and increase the frequency of inspections of the site. In addition, marketing authorisation holders for EU medicines will be required to perform additional tests on all active substances supplied by Zhejiang Huahai.”
The action arrives as part of an investigation into Zhejiang Huahai, after impurities in the valsartan active ingredient produced by the company sparked a global recall of medicines.
Initially, the product was thought to be contaminated with only N-nitrosodimethylamine (NDMA), but this later extended to include N-nitrosodiethylamine (NDEA) – both are listed by the WHO as probable carcinogens.
The EMA will take action to monitor all active substances manufactured by Zhejiang Huahai, though it noted contaminants had not been found in any of the company’s other products.
Not one company, nor one product
The scope of the overall investigation has widened rapidly since July of this year, to include more than one company and more than one ingredient.
A further company has been drawn into the investigation, due to the agency discovering NDEA contamination within Aurobindo Pharma’s production of irbesartan. As a result, the agency released a notice that irbesartan produced by the company would no longer be allowed into the EU.
It also outlined that the investigation will continue into other ‘sartans’, specifically candesartan, irbesartan, losartan, and olmesartan.
