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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

Global Pharma Guidance Tracker – March 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

Canadian HTA Consults On Improvements To Drug Review Processes

Proposals on reforming health technology assessment processes would “improve the accessibility and appropriate use of publicly funded drugs,” says Canadian health technology appraisal body, CADTH.

North America Canada

Canada Seeks To Make Decentralized Trials More Practical For Sponsors

By formally adopting a modernized definition of a clinical trial site, Health Canada is hoping to provide greater flexibility to sponsors who want to incorporate decentralized elements in their trials.

Clinical Trials Regulation

TRIPS Waiver Negotiators Reach Compromise, But Getting Consensus Is Uncertain

Proposed agreement limits waiver of certain patent rights to COVID-19 vaccines with potential to extend to COVID-19 diagnostics and therapeutics. India, South Africa, US and EU have agreed to the compromise but whether it becomes final depends on other WTO member countries.

Coronavirus COVID-19 Intellectual Property

Canada Considers Extending Readiness Inspections To Non-COVID-19 Trials

Health Canada’s early inspection program helps sponsors of COVID-19 clinical trials better identify gaps in their procedures before enrolling patients. It also provides intelligence on sites that may need to undergo a full GCP inspection later. 

Clinical Trials Compliance

Global Pharma Guidance Tracker – February 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

Need For Skilled Workforce A Key Issue In Countries Using mRNA Tech Transfer

The World Health Organization is ramping up its efforts to provide lower-income countries with the ability to produce their own biological products, such as vaccines and monoclonal antibodies. A new biomanufacturing training facility is in the works, and more recipients of mRNA technology transfer for vaccine production are being chosen.

International South Africa

Coronavirus Notebook: UK Sets Up ‘Pioneering’ Vaccines Lab, MSF Piles Pressure On TRIPS Waiver Holdouts

The UK has OKd trials of a new AI-derived combination treatment from Canadian firm Skymount Medical. Health Canada has approved Novavax’s COVID-19 vaccine, and Australia has given the go-ahead to use Moderna’s Spikevax in children aged six years and up.

Europe United Kingdom
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