Research suggests almost 70 percent of global clinical trials have been disrupted by enrolment suspensions caused by the COVID-19 pandemic.
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UK Medicines and Healthcare products Regulatory Agency (MHRA)
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Md Saddam Nawaz discusses four guidances released by the MHRA to help firms navigate the regulatory waters during the COVID-19 pandemic.
How modern chromatography data systems are improving regulatory compliance in pharmaceutical manufacturing
Delivering confident QA and QC in pharmaceutical manufacturing is of critical importance. This article discusses how the latest chromatography data systems are ensuring compliance with modern regulatory requirements.
Many COVID-19 patients who are admitted to intensive care in the UK, and globally, require mechanical ventilation. However, our healthcare systems are not prepared for the vast numbers of patients requiring this form of treatment. In this article, Adrian Toutoungi expounds how government and industry is working to push production…
In a Q&A with European Pharmaceutical Review, Marie Manley, Partner at Sidley Austin and Will Holmes, Associate at Sidley Austin discuss the post-Brexit landscape for Life Sciences.
The UK MHRA granted expedited acceptance for the Phase II trial of MRx-4DP0004, a live biotherapy product and targeted immunomodulatory therapy.
Teva has informed the MHRA that the GTIN number found on a batch of levofloxacin tablets is incorrect, prompting the Medicines Defect Information alert.
Marie Manley and co-authors from Sidley Austin explain the updates to regulations in the EU and UK in light of the COVID-19 coronavirus pandemic.
The MHRA and Council of Europe have both announced measures to prevent the spread of falsified or unlicensed COVID-19 medical products.
In the face of the coronavirus pandemic, restrictions and extreme situations may require changes to ongoing or upcoming clinical trials. These are the key recommendations from the EC, MHRA and FDA.
A barcode for paracetamol 250mg/5ml oral suspension displays the wrong strength when scanned, prompting the MHRA to announce the defect information.
A Class 4 falsified medicines directive (FMD) has been issued by the MHRA because medicines may have left the legal supply chain to be reintroduced later through HMS Wholesale Limited.
Operation Pangea has revealed a large number of falsified coronavirus treatments, while the MHRA has seized 871,616 doses of other unlicensed medicines.
The UK MHRA has announced that the approximately 3.5 million unlicensed erection pills seized last year are worth more than £10 million.
The UK MHRA has announced that Emerade 150 micrograms solution for injection is being recalled due to an error in one component of the auto-injector.