Marketing Authorisation

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…
Marketing Authorisation Holder GMP-related Responsibilities

Marketing Authorisation Holder GMP-related Responsibilities

Our Regulatory Affairs team have produced this article with the aim of summarising the key elements of the EMA Reflection Paper and the GMP-related responsibilities that apply to Marketing Authorisation Holders. The article also aims to assist our clients in…
Clinical Development Practices & Regulations

Clinical Development Practices & Regulations

Clinical Development Practices and Regulations are the main focus for our Q2 Industry Update. We also include important information about COVID-19, expertly compiled by Christina Hägglund, QA Manager, S-cubed Ltd. Read all the latest regulatory news here. You can download…
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…