EU regulators outline approach to nitrosamine impurities in human medicines

In September 2019, the European Medicines Agency (EMA) initiated a referral of Article 5(3) of Regulation (EC) No 726/2004 (relating to the authorisation of medicinal products for human use). The EMA has now released a document detailing its approach to implementing the outcome of this referral.

The referral to the Committee for Medicinal Products for Human Use (CHMP) was triggered by the EMA’s executive director requesting the Committee to conduct a scientific evaluation on the presence of nitrosamine impurities in human medicines containing chemically synthesised active pharmaceutical ingredients (APIs). Following the review, the CHMP’s two main outcomes were:

  • General guidance to manufacturers on dealing with the presence of N-nitrosamines in all human medicinal products.
  • A request for marketing authorisation holders (MAHs) to expand their review of medicines to also include biologicals.

Thereafter, a dedicated meeting was held by the European Medicines Regulatory Network (EMRN) to harmonise the approach for implementing the outcomes of the CHMP’s review. This meeting identified key success factors for the implementation of the CHMP opinion:

  • As simple an implementation as possible from an organisational perspective
  • As efficient an implementation as possible from an organisational perspective
  • Alignment within the EMRN and maintenance of this throughout the implementation phase
  • A dedicated transparency and communication approach.

Click here to access the recently published document which provides clear details on the harmonised approach.

It is intended to be read in conjunction with the CHMP assessment report on the referral which can be found here, and also with a Q&A document for MAHs which can be found here.