Quality Systems

Articles

Find links to pertinent regulatory and standard setting resources, guidance documents, and guidelines.

Resources, Guidelines, and Guidance Documents

Connect with pharmaceutical and healthcare regulatory authorities around the world via this directory.

Regulatory and Standard Setting Organizations

The UK's MHRA has joined the Australia-Canada-Singapore-Switzerland (ACSS) Consortium of regulators.

MHRA Joins the Australia-Canada-Singapore-Switzerland Consortium

The agency sent an open letter to European Ombudsman Emily O’Reilly affirming the agency’s intention to apply the same standards to the evaluation of COVID-19 treatments as it does to other medicines.

EMA Confirms Standards for COVID-19 Treatment Evaluations

Felicity Thomas is Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

A comprehensive rewrite of Annex 1 has been proposed and aims to organize and structure requirements in 10 specific sections.

Unlocking the Key Changes to Annex 1

Sean Milmo is a freelance writer based in Essex, UK.

Regulatory bodies are adapting to new ways of working to cope with the impact of COVID-19.

Regulating with Flexibility: The Pandemic Effect

The European Medicines Agency has started a rolling review of AstraZeneca’s COVID-19 vaccine.

Regulatory Review of COVID-19 Vaccine Begins in Europe

Symbiosis has successfully completed a scheduled inspection by MHRA.

Symbiosis Successfully Completes MHRA Audit Inspection

ISPE has released new guidance on the cleaning validation lifecycle, written by a group of experts and reviewed by regulators and practitioners.

ISPE Releases Cleaning Validation Guide

The agency’s human medicines committee is endorsing the use of dexamethasone in COVID-19 patients requiring oxygen therapy.

Regulatory/GMP Compliance, Europe