MHRA Updates and Global Alignment for Product Recalls Defective medicinal products are under sharper regulatory scrutiny than ever. In early 2026, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) released an updated Guide to Defective Medicinal Products, signalling a refreshed emphasis on rapid defect detection, structured investigations, and decisive recall process. In Australia,…
How external safety bulletins can strengthen your internal quality system Regulators routinely publish a wide range of external safety communications including alerts, advisories, recall notices, and safety roundups. Many organisations treat these communications as background noise but, in reality, these publications are a powerful and underused resource. They contain a wealth of regulatory signals about…
Navigating the 2024 UK Post-Market Surveillance Amendments for Medical Devices In a significant step toward strengthening patient safety and aligning with global best practices, the UK government introduced the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (S.I. 2024/1368). These regulations, which amend the UK Medical Devices Regulations ,2002, came into force on…
On 01 September 2020, the Medicines and Healthcare products Regulatory Agency (MHRA) published new guidance on how medical devices will be regulated in the UK from 01 January 2021, following the UK departure from the European Union. What does this mean for Australian based medical device manufacturers wishing to place their device on the UK…
How is the pharmaceutical manufacturing industry around the world expected to continue production during the COVID-19 pandemic? What control measures should be in place to help prevent or mitigate the potential adverse effects of COVID-19 on the safety and quality of products? In April 2020, the UK Medicines and Healthcare products Regulatory Agency (MHRA) published…
The Medicines and Healthcare Products Regulatory Agency (MHRA) is an executive agency of the Department of Health in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are acceptably safe. It is the equivalent of the TGA (Therapeutic Goods Administration) here in Australia. Both administer compliance matters in Good…
In July 2016, the MHRA released a draft document for consultation entitled MHRA GxP Data Integrity Definitions and Guidance for Industry. As the name suggests, it is a glossary of DI terms where the definitions are further explained with some context to aid in applying the existing regulations available. This is an update to their…
Brexit causes questions to arise as to the future of the EMA, located in Canary Wharf, London and also about MHRA’s continued contribution to the regulatory control of drugs in the European Union (EU) following the recent Brexit, referendum in which the UK voted to leave the EU. The reality is probably that nothing will…
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