Nitrosamines Risk Evaluation: deadline extended due to coronavirus spreading.
by PQE Group
As indicated in our insight news, the European Medicines Regulatory Network agreed to proceed with the extension of the Step 1 (risk evaluation) deadline of Nitrosamines impurities risk evaluation, formely already extended to October 1st, 2020, to the new dates of March 1st and July 1st according to the type of medicinal products as following:
- March 31st for Chemical medicines.
- July 1st for Biological medicines.
Deadline extended due to covid-19 spreading.
The decision to extend the deadlines (2) to March 31st 2021 (Chemical Products), and July 1st (Biological Products), after the first extension to October 1st 2020 (1), and originally scheduled on March 26th 2020,
was taken after considering the reports on challenges encountered by several pharmaceutical companies trying to meet the original deadline, due to the severe restrictions put on by local authorities to fight the spreading of sars-cov-2, covid-19 disease.
EMRN encourages companies to complete Step 1 in advance, and take actions.
However, according to EMRN the deadline should not be considered as a reason to procrastinate Risk Evaluation, and generally the Nitrosamines risk containment: whenever possible, the European Medicines Regulatory network still encourages marketing authorization holders to complete the Step 1 and to submit the evaluation outcome before the extended deadline; for same reason, national authorities still should be as soon as nitrosamine impurities are found, and generally, marketing authorization holders should assess immediate risk to patients, and take necessary actions to avoid their exposure to Nitrosamines impurities with no delay.
Want to know more?
PQE Supports Marketing Authorization Holders, Manufacturers of API and Manufacturers of Finished products.Our experts have significant expertise with the quality risk management principles (ICH Q9 guideline) and principles of assessment and control of mutagenic impurities in pharmaceuticals (ICH M7 guideline): we provide full support on Risk Evaluation, Risk Management and Regulatory Requirements (ICH Q9 & ICH M7 guidelines).
Check out Regulatory and Compliance Services, and contact our team to request a meeting with our experts.