UK Marketing Authorisation Holders (MAH) should be reviewing their manufacturing processes to identify and diminish any risk of the presence of nitrosamine impurities in their medicines.
Nitrosamines have been found to hold carcinogenic properties, and have recently been discovered in common generic medicines across the world, such as ranitidine, losartan and metformin. This has led to global regulatory authorities to encourage all MAH’s and manufacturers of active pharmaceutical ingredients (API) to conduct reviews of their manufacturing processes.
The UK Medicines and Health Regulatory Authority (MHRA) have recently published a new guidance detailing the precautionary steps to be taken to submit a risk evaluation of manufacturing procedures, in accordance with the Committee for Medicinal Products for Human Use (CHMP) opinion under Article 5 (3) of Regulation (EC) No. 726/2004. MAHs should consider the API and finished product manufacturing process, as well as arrangements for prevention of nitrosamine formation and contamination.
For all products licensed in the UK under national, mutual recognition (MRP), and de-centralised (DCP) procedures, MAHs should follow the steps outlined in the guidance. Step 1 requires the submission of one of two templates provided in the guidance; one for “no risk” or one for “risk identified”. These should be submitted via the MHRA portal or the Common European Submission Portal (CESP), as appropriate.
Step 2 involves submission of either a “no nitrosamine detected” or a “nitrosamine detected” form, which can be accessed on the Co-ordination Group for Mutual Recognition and De-centralised Procedures – Human (CMDh) website.
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