The deadline for step2 for medicinal products with chemically-synthesized APIs in EMA, the 26th of September 2022, is upcoming. EMA has denied the extension for step2 in the 11th revision of guidance. On the other hand, pharmaceutical companies will request an extension of the deadline for Step2 and Step3 to FDA, according to @ASrinivasan’s post.
The reason that many people did not find nitrosamines is that they did not look for them properly. Most sponsors looked for 7-8 nitrosamines based on the preliminary comments of the regulatory organizations. Also, they assumed their APIs and DPs, which are secondary and tertiary amines will not show nitrosamines as they dont have viable source of nitrites in the products. But that is all changing. Any drug with a secondary or tertiary amine when tested is showing copious amounts of nitrosamines. So, the problem is much deeper than most of the regulatory authorities thought it was. I dont have any data to post though.
Thank you for sharing your thoughts, @ASrinivasan. Due to your repeated cation, we could understand how significant the impact of NDSRIs is in Nitrosamine risk assessment. We were somewhat more optimistic than conservative about nitrosamine contamination. It takes time to overcome this problem ideally. And we need more information about it.
