EMA’s Nitrosamine Implementation Oversight Group

The Nitrosamine Implementation Oversight Group (NIOG) was set up by the European medicines regulatory network (EMRN) to oversee the harmonised implementation of the CHMP opinion on nitrosamines in human medicinal products.

Set up by the network under its February 2021 implementation plan, the NIOG will act as the main interface between regulators and the pharmaceutical industry when it comes to discussing regulatory and scientific developments in the field of nitrosamines. The NIOG contains representatives from the Committee for Medicinal Products for Human Use (CHMP), Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), European Directorate for the Quality of Medicines (EDQM) and European Medicines Agency (EMA).

The NIOG is an oversight group designed to have high level interactions with industry and not in-depth scientific discussions. In such meetings the NIOG will discuss priority topics and liaise with working parties to ensure the topics are appropriately discussed. Separately, working parties will meet with industry stakeholders for more in-depth discussions where the outcomes will be fed back to the NIOG to strive for international convergence. NIOG-industry interactions will be bi-annual initially whilst working party-industry interactions will be topic driven and organised in May 2021.

The first meeting of the group on 31 March 2021 set out the structure of the organisation, its work plan and operating methods. In this meeting a summary of the planned activities of the NIOG were set out:

  • Provide non-product specific oversight of the implementation of Article 5(3) with progress reported to the EMRN
  • Queries from the CMDh, CHMP members, EMA and International Partners to be included when gathering new scientific questions related to methodoly
  • Review and update existing guidance or publish new guidance
  • Support drafting guidance and training assessors
  • Address any specific issues of the call for review
  • Ensure consistent interaction with stakeholders in the pharmaceutical industry

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