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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

Global Pharma Guidance Tracker – June 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

Canada Says Reference Price Changes Could Save Payers Billions

Changes to Canada’s reference pricing system kick in on 1 July and could save billions.

North America Canada

Coronavirus Notebook: Adapted Comirnaty Vaccine Under EU Review, Sanofi & GSK Laud Next-Gen Booster

Valneva expects its vaccine candidate to be approved this month. Meanwhile, the core functions of the UK’s Vaccine Taskforce are to be transferred to the UK Health Security Agency and the Office for Life Sciences.

Europe International

Global Pharma Guidance Tracker – May 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

The Quality Lowdown: Wishing Wished-For FDA Re-Inspections Had Gone Better?

As the COVID-19 pandemic wore on, industry clamored for the US FDA to re-inspect troubled drug manufacturing plants remotely if need be to clear them for new approvals. Now FDA investigators are out in force and early returns from Sun, Aurobindo, Lupin and Sterling suggest these re-inspections will be as tough as ever.

Manufacturing Quality

Global Pharma Guidance Tracker – April 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

Biosimilars ‘Policy Salad’ Setting Back Sector, Canadian Study Says

The Ontario Drug Policy Research Network has released a new study on biosimilar uptake across Canada, where the use of biosimilars is relatively low in comparison to other OECD countries.

Biosimilars Canada

Canada Pulls Controversial Pricing Measures

Some measures aimed at reducing medicine prices in Canada have been dropped, to the relief of the pharmaceutical industry.

North America Canada

Interim Measure Offers Clarity On E-Labeling In Canada

While the Canadian regulator finalizes its policy on using electronic labeling, it has issued an interim order that explains what information companies can include in electronic platforms that are linked to a drug’s physical label. 

Canada Regulation
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