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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