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COVID-19: regulatory implications for the UK and European life sciences industry
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.
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Regulatory responses to the COVID-19 coronavirus
European Pharmaceutical Review brings you the latest updates from regulatory bodies across the globe in response to the COVID-19 coronavirus.
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MHRA issues FMD over HMS Wholesale Limited products
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.
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CMA launches COVID-19 taskforce to combat drug price hikes
In the UK, the CMA has announced it will establish a taskforce to handle businesses that exploit the COVID-19 outbreak and inflate drug prices.
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UK bans parallel exporting of crucial medicines to help COVID-19 patients
The UK government has announced that the parallel export of certain essential medicines is banned, to preserve drugs for the treatment of coronavirus patients.
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MEDICRIME – tackling falsified medicines in Europe
In 2014, medicines were stolen from Italian hospitals and resold across Europe. The authors of a new report highlight the flaws in regulations that handed the perpetrators insufficient sanctions and explain why MEDICRIME provides a better regulatory framework.
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Global operation identifies 34,000 falsifed coronavirus medicines
Operation Pangea has revealed a large number of falsified coronavirus treatments, while the MHRA has seized 871,616 doses of other unlicensed medicines.
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Court rules against Mallinckrodt ARD LLC in Medicaid rebates lawsuit
The US District Court of Columbia has upheld the decision to alter rebate calculations and left Mallinckrodt with a retroactive liability of $650 million.
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Limiting antibiotic manufacturing discharge in Indian wastewater
During the manufacture of antibiotics, residues can contaminate the environment through wastewater, leading to antimicrobial resistance. However, a new government initiative in India aims to prevent this by regulating effluent.
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CMA levels over £3.4m in fines for competition law breaches
The UK’s Competition and Markets Authority (CMA) has fined four companies in because of anti-competitive practices in the supply of nortriptyline.
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India to restrict 10 percent of medicine exports due to coronavirus
According to reports, the Indian government has said that 26 active pharmaceutical ingredients and medicines will be under export restrictions due to the impact of COVID-19.
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India to hold pharma companies responsible for drug quality after reforms
Amendments to regulations in India will make pharmaceutical companies accountable for the quality and safety of medicines, alongside manufacturers.
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Blowing the whistle: tackling misconduct in the life sciences sector
A survey by the Internal Investigations Forum has highlighted vast differences in the quantity and quality of complaint reports globally and that companies need to nurture trust to improve internal relations. Here, Gary Giampetruzzi, Thomas Hauser and Jenny Pu provide an analysis of the results, including where there are areas…
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ABPI responds to UK points-based immigration system
The ABPI has outlined how the new immigration system in the UK will affect life science workers and businesses, emphasising the need for regular reviews to remain competitive.
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The importance of labelling compliance for pharma
Bart Vansteenkiste explains why it is important to validate pharmaceutical labelling compliance to ensure good manufacturing practice.
