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Ian Schofield

Edinburgh, U.K
Ian Schofield has been writing on issues affecting the pharmaceutical and biotech industry since the mid-1980s, specialising in EU and global policy and regulatory affairs.  As well as writing, editing and commissioning articles for Pharma Intelligence, Ian works for the Ask the Analyst service, providing tailor-made answers to questions posed directly by clients. He has a degree in modern languages from the University of Bath. Outside the realm of work, Ian plays guitar in a traditional music group and also enjoys a touch of cycling and gardening. He lives by the seaside about three miles from the centre of Edinburgh.

Latest From Ian Schofield

EU Targets Generics, Inspection Shortfalls & Environmental Assessments

As the European Commission prepares to publish its proposals for overhauling the EU pharmaceutical legislation at the end of the year, member states have been discussing a range of technical and legal issues such as the scope of the centralized approval procedure, the use of electronic product information and the shortage of inspection capacities.

Europe Regulation

EMA Reviewing Bavarian Nordic’s Imvanex For Vaccination Against Monkeypox

EU member state authorities have been told they can use Jynneos, the US version of Bavarian Nordic’s smallpox vaccine, for the prevention of monkeypox. The bloc is also buying some 110,000 doses of the vaccine, with deliveries expected to begin shortly.

Europe Drug Review

EU Bodies Agree Clearer Rules On Joint Procurement Of Vaccines & Treatments

The new regulation on cross-border threats to health is the final part of the European Health Union, along with strengthened roles for the European Medicines Agency and the European Centre for Disease Prevention and Control. Its aim is to ensure collective EU action on preparedness, surveillance, risk assessment, and early warning and response in the event of health emergencies.

Europe Regulation

International Regulators Plan Roadmap For Collaborative RWE Studies

Experiences during the COVID-19 pandemic are expected to help identify future opportunities for regulatory cooperation on real-world evidence and avoid divergent decision-making for products including advanced therapies and personalized medicines.

Coronavirus COVID-19 International

EMA Assessing Variant-Adapted Spikevax, Probes Heart Inflammation With Nuvaxovid

A rolling review of an adapted version of Moderna’s COVID-19 vaccine Spikevax aimed at variants of SARS-CoV-2 has begun at the European Medicines Agency. The EMA has also given an update on its latest vaccine safety reviews, including reports of heavy menstrual bleeding with Spikevax and Comirnaty.

Europe Coronavirus COVID-19

WTO Decision On Access To COVID-19 Vaccines: A Waiver In Name Only?

R&D-based companies have denounced what they see as a dangerous and unjustified attack on intellectual property after the World Trade Organization’s ministerial conference finally adopted a decision on an IP waiver for COVID-19 vaccines. NGOs, by contrast, say the decision amounts to little more than a limited exception to existing rules on the compulsory licensing of medicines.

International Coronavirus COVID-19
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