Nitrosamines

EMA Publishes Updated Guidance on Nitrosamines Impurities

EMA Publishes Updated Guidance on Nitrosamines Impurities

EMA Publishes a New Question and Answer Document for Marketing Authorisation Holders on the CHMP Opinion for the Article 5(3) referral on Nitrosamine Impurities in Human Medicinal Products (EMA/409815/2020) The European Medicines Agency (EMA) have published a new ‘question and…
Nitrosamine Risk Evaluation for Marketing Authorisation Holders

Nitrosamine Risk Evaluation for Marketing Authorisation Holders

UPDATE: Latest news from MHRA The deadline for provision of the step 1 responses has been extended for an additional 6 months to 1 October 2020. This deadline is subject to review in light of the ongoing Coronavirus (COVID-19) outbreak…
MAH Nitrosamine Risk Evaluation update – 1 month to go

MAH Nitrosamine Risk Evaluation update – 1 month to go

A reminder that the Risk Evaluations for the potential for nitrosamine contamination need to be submitted by 26 March 2020. What you need to know The national regulatory agencies may have some differences in their requirements for submitting the outcome…
Nitrosamine MAH Risk Assessment – Two Months to Go

Nitrosamine MAH Risk Assessment – Two Months to Go

Human medicinal product licences to be reviewed for the presence of Nitrosamine Impurities On 26 September 2019 the European Medicines Agency requested that, as a matter of precaution, all Marketing Authorisation Holders (MAH) should perform a risk evaluation for all…
Nitrosamines, TOPRA, Drug Development News

Nitrosamines, TOPRA, Drug Development News

Industry Insights for Q4 - 2019 Our latest regulatory updates for the final quarter of the year covers news from the FDA, EMA, important news about nitrosamines impurities, and much more. Christina Hägglund compiles the latest regulatory updates from around…