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Global

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Pandemic Treaty: WHO To Broadcast Videos Of Stakeholders ‘Wishlists’

Hundreds of videos have been sent in by people interested in contributing to the future pandemic treaty proposed by the World Health Organization.

Coronavirus COVID-19 Regulation

International Trial Organizations Address Reporting Of Unforeseen Disruptions

Drawing on lessons learnt from unprecedented interruptions to clinical trials over the past few years due to such things as the pandemic and the war in Ukraine, new advice has been issued on adjustments needed in clinical study reports to document these disruptions. 

Clinical Trials Regulation

How Decentralized Clinical Trials Are Delivering Time And Cost Efficiencies

A modeling study, an analysis of a dozen clinical trials and a survey of 400 clinical trial executives all show how using decentralized elements in trials can result in faster, less expensive and more engaging research.

International Europe

EU, US & Japan Welcome India In ‘Critical’ Pharmacopeial Harmonization Move

The Indian Pharmacopoeia Commission was the only applicant that made the grade for entry in a pilot program that was launched to assess countries that want to join the EU, US and Japan as full members of the 33-year-old Pharmacopoeial Discussion Group.

India Quality

Sterile Drug GMPs: CCS Tool Could Help Bridge Compliance Gaps As Annex 1 Revisions Take Effect

Experts who led PDA’s interactions with EU, PIC/s and WHO authorities on first-ever comprehensive revision of sterile drug product manufacturing guidance recently shared insights on implementation priorities with the Pink Sheet.

Manufacturing Quality

New Consortium Pledges To Boost Supply Of COVID-19 Antivirals In LMICs

Pfizer is donating 100,000 doses of its COVID-19 antiviral product, Paxlovid, to kick-start test-and-treat programs in lower income countries that will eventually use generic versions of the product.

International Middle East and Africa

Faricimab & Asciminib Are First Products To Be Approved By All Access Consortium Regulators

A therapy for wet age-related macular degeneration and a new drug for leukemia have become the first two products to be approved by all countries involved in the international Access Consortium.

International Approvals

Global Coalition Develops Consistent Terminology To Support Decentralized Trials

As regulatory agencies around the globe work on initiatives to support decentralized clinical trials, the Decentralized Trials & Research Alliance says a shared language is needed to facilitate the global adoption of such trials.

International Clinical Trials

Global Pharma Guidance Tracker – August 2022

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

New Global Venture Offers Free Access To Promising Antimalarial Compounds

With resistance to insecticides growing, new medicines are urgently needed to tackle diseases transmitted by mosquitoes, such as malaria and dengue, particularly in lower- and middle-income countries.

Infectious Diseases Research & Development

WHO Steps Up Drive To Build Local Drug & Vaccine Production In Lower-Income Countries

The COVID-19 pandemic has underlined the need for less well-resourced countries to improve access to medicines, vaccines, medical devices and other health products by building their own production capacities.

International Vaccines

ICH Finalizes Guide To Cutting Down On Rat Carcinogenicity Studies

An ICH guideline describes the “weight of evidence” criteria that in some cases may provide an adequate assessment of human carcinogenicity risk without the need for data from a two-year rat carcinogenicity study.

International Drug Safety
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