Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Global

Set Alert for Global

Continuous Manufacturing Guidance From US FDA Aims For Wider Industry Adoption

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.’

Manufacturing Guidance Documents

ICH Emphasizes Need For Quality In Clinical Trials

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. 

Clinical Trials Regulation

EU Ups The Ante On Opposition To COVID-19 IP Waiver

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.

International Europe

Under The Shadow Of Drug Price Reform, US Tax Policies Still Challenge Pharma

Congress is considering legislation that would reverse some of the Trump administration's friendly corporate tax policies, presenting another challenge to the biopharmaceutical industry.

Politics Sales & Earnings

ICH Q9 Revision Delayed By Three Months Due To COVID; Focus Spans Risk Assessments, Shortages

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.

Manufacturing Quality

Global Pharma Guidance Tracker – September 2021

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.

Guidance Documents Regulation

Medicines Patent Pool Welcomes WHO’s Updated Essential Medicines List

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.

International Market Access

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.

Europe United Kingdom

Coronavirus Notebook: WHO Backs MAb Combo, EMA Assessing Moderna Booster Jab

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.

Europe International

EU Joint Regulatory Assessment Project Bears Fruit In COVID-19

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.

Europe Regulation

Regulatory Reliance Behind The Success Of African COVID-19 Vaccine Approvals

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.

International Regulation

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.

Europe International
See All
UsernamePublicRestriction

Register