As coronavirus roils region, EU device body adamant about steps to hit MDR deadline

Europe – EU Regulatory Roundup

MHRA Approves Adapted CPAP Device for COVID-19, Shares Design Specifications The United Kingdom’s Medicines and Healthcare and products Regulatory Agency (MHRA) has approved an adapted...
New Council of Europe resolution to promote pharmaceutical care in Europe

Europe – Products and extemporaneous preparation of paediatric formulations that may be useful in...

During the COVID-19 pandemic caused by SARS-CoV-2, clinical trials aimed at demonstrating the safety and efficacy of established active substances in this new indication...
Advice for Management of Clinical trials in relation to Coronavirus

UK – MHRA regulatory flexibilities resulting from coronavirus (COVID-19)

We are working closely with the Department of Health and Social Care (DHSC) and other healthcare partners and stakeholders to rapidly develop a package...
NICE pushes Doptelet for pre-surgery liver disease treatment

UK – NICE publishes second set of rapid COVID-19 guidelines

The National Institute for Health and Care Excellence (NICE) has published its second set of rapid guidelines to cover the provision of radiotherapy services...
Clinical Trial Regulation : Update

Europe – Amended European Union recommendations for the seasonal influenza vaccine composition for the...

The meeting of the Ad hoc Influenza Working Group of the Biologics Working Party (BWP) was convened in order to recommend the virus strains...

Europe – EMA : COVID-19: chloroquine and hydroxychloroquine only to be used in clinical...

Chloroquine and hydroxychloroquine, two medicines currently authorised for malaria and certain autoimmune diseases, are being investigated worldwide for their potential to treat coronavirus disease (COVID-19)....

Europe – EMA : Explanatory note on general fees payable

General, non-pharmacovigilance fees payable to EMA by applicants and marketing-authorisation holders are increasing by 1.6% on 1 April 2020. Full details of the new fee levels...
Note on EU implementation of ICH Q12 (guideline on technical and regulatory considerations for pharmaceutical product lifecycle management)

Europe – ICH guideline S11 on nonclinical safety testing in support of development of...

The purpose of this document is to recommend international standards for, and promote harmonisation of, the nonclinical safety assessments to support the development of...
Converting Centrally Authorised Products (CAPs) to UK Marketing Authorisations (MAs) in a no-deal Brexit, 'grandfathering' and managing lifecycle changes

Europe – MHRA Blocks 135 Drugs From Parallel Export

As drug shortage questions and increasing demands loom amid the coronvirus pandemic, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) this month added...

Europe – Advancing regulatory science in the EU – new strategy adopted

EMA has published its Regulatory Science Strategy to 2025  today. The strategy provides a plan for advancing regulatory science over the next five years, covering...