Other Countries

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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.

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

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. 

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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.

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.

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.

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. 

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.

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.

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.