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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

Canada Launches ‘More Responsive’ Post-Marketing Drug Evaluation Program

Canada’s health technology appraisal body, CADTH, has launched a new program that will harness real-world evidence to provide more information and advice on the safety and effectiveness of drugs that are already approved.

North America Canada

UK & Canada Expand Scope Of Mutual Recognition Of GMP Inspections

Drug importers can benefit from the UK and Canada’s decision to recognize the outcomes of each other’s manufacturing inspections conducted in foreign jurisdictions.

United Kingdom Canada

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

How Africa Can Meet Its Daunting Production Challenge For Critical Disease Vaccines

Africa is taking steps to massively increase its vaccine production capacity and reduce its heavy dependence on other countries for supplies. Muthoni Wanyeki of the Open Society Foundations explained to the Pink Sheet how COVID-19 has highlighted the need for action and why it is important to keep up the momentum achieved so far.

Middle East and Africa South Africa

'Status Quo' Interim Pricing Guidance Now In Force In Canada

Provisional guidance on controversial pricing reforms is now in place in Canada.

North America Canada

EU, UK & Brazil Take Steps To Boost Access To Monkeypox Vaccines

Regulators in the EU and the UK are exploring the intradermal use of monkeypox vaccine as a dose-sparing measure to stretch out scarce supplies, while Brazil is to waive the registration requirements for imported vaccines and therapeutics for monkeypox.

Vaccines Infectious Diseases

Aspen Setback Illustrates Need For Africa To Build Up Vaccines Market

A coordinated effort will be needed if Africa is to increase its manufacturing capacity and ensure a market for domestically produced vaccines.

Middle East and Africa Vaccines

Latin American Countries To Coordinate Purchase Of Monkeypox Vaccine

Member states of the Pan American Health Organization have approved a resolution to combine purchasing power to buy monkeypox vaccines.

South America North America

All Eyes On Rwanda As Africa Builds Up Regulatory & Manufacturing Abilities

The small central African country has been chosen to host the planned African Medicines Agency and is also set to be a key player in medicines and vaccines manufacturing technology on the continent.

Middle East and Africa Rwanda

Global Pharma Guidance Tracker – July 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

Brazil Waters Down Compulsory Licensing Law

Companies in Brazil will not have to provide know-how and other detailed information on patents that are subject to compulsory licenses, although other provisions of a law passed last year to ease the compulsory licensing process remain in place.

Brazil Coronavirus COVID-19
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