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Drug Sponsors Invited To Trial Pre-Submission Meetings With South African Agency

The South African Health Products Regulatory Authority is planning to introduce meetings with drug sponsors that can help identify and resolve potential shortcomings in marketing applications before they are submitted for evaluation.

South Africa Regulation

Africa Vaccine Supplies To Rise After ‘Worst Pandemic Week Ever’

Despite an alarming surge in coronavirus cases across the African continent, there are hopes of a substantial rise in vaccine supplies in the coming months.

Middle East and Africa Coronavirus COVID-19

Global Pharma Guidance Tracker – June 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

Coronavirus Notebook: Vaccine Safety Study Kicks Off In UK, Govt Plans Booster Vaccination For Most Vulnerable

A new international task force has used its first meeting to call for more access to COVID-19 vaccines and therapies in developing countries, and the World Bank and other finance institutions are putting money into South African firm Aspen Pharmacare to boost the production of vaccines.

Europe United Kingdom

COVID-19 Causes Further Delay To Canada’s Controversial Pricing Reforms

A delay to implementing drug pricing reforms is an opportunity for Canadian authorities to come up with better proposals, say industry representatives, while authorities remain adamant that action is necessary to lower prices.

North America Canada

New Alliance Urges Countries To Ratify Treaty On African Medicines Agency

Stakeholders are making a concerted effort to get the new agency off the ground, saying it will not only reduce drug approval times but help to drive industrial and economic growth in Africa. The European Medicines Agency is offering to share its experience in regulatory collaboration and network building.

Middle East and Africa Regulation

Canadian Government Slammed Over 'Intransigence' On Compulsory Licensing

The Canadian government has come under fire for failing to take the necessary steps that would allow a Canadian company to produce generic versions of COVID-19 vaccines.

North America Canada

Coronavirus Notebook: EMA OKs More Vaccine Production Plants, WHO Sounds Alert Over Africa

Vaxzevria should not be given to people who have had capillary leak syndrome, the EU regulator says. The G7 leaders have made big pledges on vaccine donations, and international regulatory bodies have issued a guide to shoring up confidence in vaccination.

Coronavirus COVID-19 Vaccines

Tech Transfer Deals See Argentina And Serbia Produce COVID Vaccine

The Russian Direct Investment Fund says it has 20 technology transfer and production agreements in place in 13 countries across the world.

Europe Serbia

Global Pharma Guidance Tracker – May 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

Coronavirus Notebook: COVAX Exceeds Vaccine Funding Target, Canada OKs Mix-And-Match Dosing

In a sign of growing support for more equitable vaccine distribution, many donors have pledged either money or doses to lower-income economies. The World Health Organization has granted emergency use listing to another Chinese vaccine, and Russia’s Sputnik V is to be produced in Bahrain for the MENA region.

International Europe

Drug Importation: Biden Response To PhRMA Suit Highlights Infeasibility Of Trump-Era Rule

Biden administration asks court to dismiss PhRMA’s lawsuit against Trump-era pathway for drug importation from Canada because FDA has not yet cleared any Section 804 Importation Programs (SIPs). The brief outlines the high hurdles to getting a SIP approved and Canada’s opposition to the programs. It's not clear if the Biden team plans another more feasible route to drug importation.

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