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Coronavirus Notebook: EMA Issues Guidance On Development Of Variant Vaccines, EU Leaders Urge Production Ramp-Up

 
• By Ian Schofield

A batch of AstraZeneca/Oxford University coronavirus vaccines has arrived in Ghana, the first country in the world to receive vaccines via the COVAX Facility.   

World Global Ecology International Meeting Unity Learning Concept
Global efforts are under way to boost COVID-19 vaccinations • Source: Shutterstock

The European Medicines Agency has issued guidance outlining the regulatory requirements companies will need to meet if they plan to modify their coronavirus vaccines to address new SARS-CoV-2 variants.

The guidance was published on the same day that EU heads of state and government pledged to support efforts to increase vaccine production and R&D and to adjust vaccines...

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More from Europe

US ‘Most Favored Nation’ Pricing Could be Game Changer for Drug Access In Germany

 
• By Francesca Bruce

In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.

ClinicalTrials.gov Or ISRCTN: Getting Transparency Right For UK Trials

 
• By Vibha Sharma

ISRCTN’s systems are being redesigned to facilitate compliance with upcoming requirements in the UK’s clinical trials legislation.

Spain Slashes Wait Between EU Drug Authorization And Financing Decisions

 
• By Francesca Bruce

Spanish authorities say that that timelines for drug reimbursement decisions can be improved further with the right submissions from companies.

Spain Beats England To Tevimbra Reimbursement Recommendations

 
• By Francesca Bruce

Spanish authorities have published more pricing and reimbursement reports as part of a new drive to increase transparency.

More from Geography

US ‘Most Favored Nation’ Pricing Could be Game Changer for Drug Access In Germany

 
• By Francesca Bruce

In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.

ICH Targets RWE, Rare Diseases, Biosimilars, ATMPs In New Guideline Push

 
• By Vibha Sharma

The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.

Quotable: Top Experts On Policy Hot Topics

 
• By Anabel Costa-Ferreira

The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.