Nitrosamine regulation implemented on time for many customers thanks to modular solution approach of Aenova

Starnberg, 28/06/2021

  • Aenova developed a comprehensive process and solution approach for marketing authorization holders.
  • Already within the first regulatory deadline, all risk assessments for customers could be prepared.
  • The deadline extension for biologic drugs expires July 1, 2021.

After the regulatory authorities had already become aware of products containing valsartan in July 2018, the worldwide recall of medicines containing metformin also attracted great attention just over a year ago. The reason for this was a contamination with carcinogenic nitrosamines. In a report, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) called on companies to take actions to limit the presence of nitrosamines in medicines for human use as far as possible and to ensure that the strict limits are not exceeded. This posed a particular challenge, first for API manufacturers, then for marketing authorization holders, as well as for contract manufacturers working for pharmaceutical companies. Within a short period of time, the Aenova Group, as the world's leading contract developer and manufacturer for pharmaceutical and healthcare companies, was able to implement a comprehensive, scientifically based modular solution for risk assessments, both in terms of content and process, and to execute this together with the customer companies for their products.

The first specifications of the EMA

In the interest of patient safety, marketing authorization holders were made responsible by the EMA to review their manufacturing processes, first for all products containing chemically synthesized active ingredients and later also for biological active ingredients, in order to identify and mitigate the risk of nitrosamine contamination where applicable. Similarly, strict nitrosamine limits were set for products. Furthermore, for all affected products marketing authorization holders needed to also implement appropriate control strategies and to further improve manufacturing processes where necessary.

The risk assessment of all products should be completed at the latest within six months after the publication of the "Information on Nitrosamines for Marketing Authorization Holders". Thereupon, the authorization holders were to inform the competent authorities when the risk assessment was completed. For this purpose, an initial deadline of 26.03.2020 applied. In the course of last year, this had to be extended initially until 01.10.2020, then again until 31.03.2021 due to the COVID19 pandemic, and applies to biological medicinal products until 01.07.2021. Aenova was able to complete all risk assessments for its own customers on time by the first deadline. Thanks to the flexible, modular structure of the Aenova approach, it can also be modified for biological medicinal products.

Read more in our current press release.

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