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Global

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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

COVID-19 Vaccines: Regulatory Consortium Addresses Way Forward With Immunobridging Studies

Drug regulators from five countries have outlined their joint expectations on the data companies must submit for the approval of next-generation COVID-19 vaccines if they opt for immunobridging studies instead of large-scale efficacy trials. 

International Clinical Trials

Coronavirus Notebook: Nobel Laureates Press Germany To Back Vaccine IP Waiver

The EU vaunts its vaccine donations and starts building resilience against future health threats, and the UK MHRA says Moderna can be used as a booster dose. Aviptadil has received scientific advice from the MHRA for its potential use as a treatment for COVID-19 patients.

Europe International

WHO Urges Pause On COVID-19 Booster Shots

The pharmaceutical industry group, IFPMA, believes that a massive scale-up in manufacturing means booster shots will not necessarily “exacerbate inequities”.

International Coronavirus COVID-19

Global Pharma Guidance Tracker – August 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

US FDA Signals New COVID-19 Vaccines Could Be Authorized With Just Immunogenicity Studies

As FDA lowers some expectations on timing of booster shots, agencys outgoing vaccine chief says second-generation COVID vaccines may be authorized without efficacy studies. Marion Gruber's conclusion was supported by many of her international regulatory peers during a WHO meeting.

Coronavirus COVID-19 Vaccines

Real-World Data: ‘Don’t Take Your Foot Off The Gas’

It is possible to maintain the current focus on the use of real-world data in drug development by finding simple solutions to existing challenges, argues an expert at a US-based RWD platform.

Real-World Evidence Clinical Trials

International Regulators Explain Work-Sharing Scheme For Biosimilars

New guidance from the ACCESS Consortium of regulators from five countries explains how biosimilar drug sponsors can apply for an internationally-coordinated review of new products.

Biosimilars Review Pathway

Pharma Pushes For Better Understanding Of Virtual Inspection Tools

As the international association of pharmaceutical inspectorates (PIC/S) draws up its strategic priorities for next five years, the pharmaceutical industry suggests it should share experience on virtual inspections and clarify how various inspection tools can work effectively together.

Manufacturing Compliance

Global Agencies Seek Clearer Steer On AI In Drug Development & Regulation

Regulators’ experiences and two hypothetical case studies form the basis of a set of recommendations on the use of artificial intelligence in areas such as safety signal detection and improving decision making, which have just been published by the International Coalition of Medicines Regulatory Authorities.

International Artificial Intelligence
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