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Draft tracks ICH document, which touts the ‘efficiency, agility, and flexibility’ of continuous manufacturing while acknowledging the challenges around the developing practice, ‘particularly for products intended for commercialization internationally.’
The International Council for Harmonisation has delivered the first of a two-part project to modernize the international good clinical practice framework by finalizing changes to its primary efficacy guideline.
Leaked documents show that the European Commission has prepared a new proposal on compulsory licensing of coronavirus products to be tabled at the World Trade Organization’s Ministerial Conference next month.
Congress is considering legislation that would reverse some of the Trump administration's friendly corporate tax policies, presenting another challenge to the biopharmaceutical industry.
Extension will add training materials with goal of reducing quality defects and recalls. Revision process will also address shortage indicators related to production failures in an attempt to head off drug shortages.
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
The World Health Organization’s updated essential medicines list includes four medicines already licensed to the Medicines Patent Pool, of which two were developed through MPP licensees. The WHO’s updated list includes SGLT2 inhibitors – oral medications used to lower blood glucose levels – for which the MPP and the International Diabetes Federation have committed to improve affordable access in low- and middle-income countries.
Coronavirus Notebook: Australia ‘Recognizes’ Unapproved Vaccines, Russia Bigs Up Sputnik’s Chances At WHO
England’s NICE has given its backing to the use of Regeneron’s Ronapreve, and the UK’s new health security body is now fully up and running.
The COVID Moonshot project has received new funding for the open-source development of new candidate therapeutics, with results expected by the end of the year.
The European Medicines Agency has reported progress with a collaborative project that involves other regulators in its assessments of COVID-19 products, and with the EU Medicines for All initiative for evaluating products for non-EU markets.
Regulatory reliance and work-sharing are becoming increasingly popular as a way of avoiding duplication and speeding up drug and vaccine assessments, but while there are many benefits, regulators should also be aware of some potential pitfalls, delegates at the TOPRA annual symposium heard this week.
Coronavirus Notebook: UK Rolls Out Ronapreve To Hospitalized Patients, Drug Safety Unit Reviews mRNA Vaccine Heart Inflammation Link
Pressure is growing on richer countries to share their excess vaccine doses, and the European Parliament has passed legislation intended to strengthen the EU’s health security framework and make joint vaccine procurement more transparent.
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