EMA to provide new guidance on avoiding nitrosamine impurities in human medicines

After various animal studies were conducted, nitrosamines have been classified as “probable human carcinogens”.

In 2018, they were detected in commonly prescribed blood pressure medicines called ‘sartans’, for example losartan, irbesartan, candesartan, leading to product recalls and a European Union (EU) review. The Therapeutic Goods Administration (TGA) of the Department of Health of Australia are also investigating potential contamination of these blood pressure medicines. Furthermore, nitrosamines have been found in a common diabetic medication pioglitazone, and batches of ranitidine. Consequently, an EU-wide review of ranitidine has now been initiated.

The European Medicines Agency (EMA) would like to emphasise that marketing authorisation holders and sponsors are responsible for their products meeting the regulations. They are responsible for ensuring the quality of each batch of their product, including that the quality of the active substance and other excipients is satisfactory, thereby reducing the risk of contamination with nitrosamines.

The TGA have mirrored the EMA and advised sponsors to:

  • “take measures to avoid the presence of N-nitroso impurities in their medicines”.
  • “implement rigorous testing of their medicines to identify the presence of any N-nitroso impurities”.

They will allow 2 years, from 13th September 2019 to 13th September 2021 for sponsors to review and adjust their processes and testing methods. If any nitrosamine compounds are found during this period the TGA will have to be notified promptly, after which further action will be taken.

To read more about the EMA’s guidance on the threat of nitrosamine compounds in human medicines, click here.

For more information on the TGA’s response, click here.