EMA: Q&A on Nitrosamines Updated to Rev. 17

To a new one! The EMA Q&A on nitrosamine impurities has been updated again after only three weeks and is now available as Revision 17 corr. The update concerns Q&As 20, 21 and 22 and a correction of the table including the potency score calculation in example 4 for N-nitroso-l-nebivolol. It had been omitted in the previously revised version 17 and has now been re-introduced.

In a nutshell:

• Q&A 20: What are the regulatory steps taken by authorities following the identification of an N-nitrosamine exceeding the AI (Acceptable Intake)?
  Q&A 21: What is the approach to control the presence of nitrosamines until a substance-specific AI is established?
  The Q&As 20 and 21 have been amended regarding the approach to control the presence of nitrosamine while the AI is being established. It is clarified that as the AIs can be established with the new carcinogenic category approach (CPCA) the approach for a universal temporary AI (t-AI) while a formal AI is established is no longer considered necessary (we reported).
• Q&A 22: What is the approach to control the presence of N-nitrosamine exceeding the AI during CAPA implementation?
  The scope of authorised products for chronic use has been extended and the applicable limits and exemptions are clarified. Reference to chronic conditions which should not be treated for more than 10 years has been removed.
• The table including the potency score calculation in example 4 for N-nitroso-l-nebivolol on page 40 has been re-introduced. It had been omitted in a previous revision.

Source:

EMA: Website on nitrosamine impurities

EMA: Q&A for marketing authorisation holders/applicants on nitrosamine impurities