News

ACCESS Consortium guidance on updating authorised coronavirus vaccines in the wake of virus mutations

The regulatory approval of COVID-19 vaccines towards the end of 2020 and start of 2021 coincided with the detection of new SARS-CoV2 strains in the UK, South Africa and Brazil. The ACCESS consortium has released a document detailing the regulatory approach for updating authorised coronavirus vaccines to target new strains. Read more “ACCESS Consortium guidance on updating authorised coronavirus vaccines in the wake of virus mutations”

EMA publishes Version 2 of its Implementation Guide for the submission of data on medicinal products

Standards developed by the International Organization for Standardization (ISO) for the identification of medicinal products (IDMP) are being adopted by the European Medicines Agency (EMA). An Implementation Guide (which the EMA has recently updated to version 2) has been created to help stakeholders prepare for the adoption of these ISO standards. Read more “EMA publishes Version 2 of its Implementation Guide for the submission of data on medicinal products”

IMDRF publishes finalised document on IVD device classification

The International Medical Device Regulators Forum (IMDRF) has published a document on the classification of in vitro diagnostic (IVD) medical devices. It has been created with the aim of harmonising the classification of IVD devices in order to ensure a globally consistent approach to premarket approval. Read more “IMDRF publishes finalised document on IVD device classification”

What is the Safer Medicines in Pregnancy and Breastfeeding Information Consortium?

This network is formed of 16 organisations from the National Health Service (NHS), regulators, and leading third sector and charitable organisations. The aim of the consortium is to improve the dissemination of information for women who are considering pregnancy, are already pregnant or are breastfeeding. Read more “What is the Safer Medicines in Pregnancy and Breastfeeding Information Consortium?”

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. Read more “EU regulators outline approach to nitrosamine impurities in human medicines”