European regulators have proposed 40 recommendations to help reduce the risk of impurities in medicines, and to ensure that regulators are better prepared to manage cases of unexpected impurities.
The recommendations aim to clarify the roles and responsibilities of the manufacturers of medicines, and to rectify guidance on controlling impurities and good manufacturing practice (GMP). The recommendations also cover the management of impurities once detected, communication with patients and healthcare professionals (HCP), and international cooperation.
The list has been created as a conclusion of an exercise drawing on lessons learnt from the recent nitrosamine contamination of various medicines. Nitrosamines are classified as probable human carcinogens. Regulators noted that nitrosamines were not previously recognised as potential impurities, when originally detected in sartan medicines.
The EU first gained awareness of their presence in some sartan medicines in mid-2018. The discovery led to swift regulatory action, including the recall of medicines and measures to stop the use of active substances from certain manufacturers. A subsequent EU review established the sources of nitrosamines and laid out new manufacturing requirements for sartans.
These recommendations created from the experience gained from the nitrosamine saga will help reduce the risk of impurities being present in other medicines and ensure that regulators are better prepared to manage cases of unexpected impurities in the future.
To view the full list of recommendations, click here.