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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.

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.

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.

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.

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.

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.

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.

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.

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

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.

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.

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.