TGA international engagement strategy 2021-2025

26 July 2021 - The TGA's International Engagement Strategy 2021-2025 describes how working with our international regulatory counterparts will benefit Australians ...

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Fit for purpose real world data assessments in oncology: a call for cross stakeholder collaboration

21 July 2021 - Real world evidence remains a promising frontier in evidence generation to support improved health related patient outcomes. ...

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How to integrate evidence from patient preference studies into health technology assessment: a critical review and recommendations

15 July 2021 - Health technology assessment agencies vary in their use of quantitative patient preference data and the extent to ...

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International regulators work towards alignment on development and authorisation of second generation COVID-19 vaccines

16 July 2021 - Regulatory convergence is critical for expediting and streamlining global development and authorisation of new or modified COVID-19 ...

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MHRA outlines two year delivery plan with ‘patient first’ focus

6 July 2021 - The UK’s Medicines and Healthcare products Regulatory Agency has revealed its new delivery plan, outlining its ...

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MHRA releases guidance in collaboration with Health Canada to improve patient safety in clinical trials through improving the quality of Development Safety Update Reports

6 July 2021 - The Medicines and Healthcare products Regulatory Agency and Health Canada have published guidance to improve the safety ...

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Australia-Canada-Singapore-Switzerland-United Kingdom (Access) Consortium

22 June 2021 - The TGA is a member of the Access consortium along with Health Canada, Health Sciences Authority of ...

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Advancing international collaboration on COVID-19 real world evidence and observational studies

4 June 2021 - Medicines regulators from around the world discussed the importance of global collaboration and information sharing in relation ...

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HumanFirst joins the FDA, HHS and more than 20 organisations and leading health companies to launch the Digital Health Measurement Collaborative Community

3 June 2021 - Digital Health Measurement Experts will work together to develop best practices and streamline health measurement using digital ...

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EMA and EUnetHTA take stock of their co-operation

1 June 2021 - The EMA and the European Network for Health Technology Assessment (EUnetHTA) have published a report on ...

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New EU health innovation rules edge closer

29 May 2021 - Three years after the original proposal, the European Union’s game changing Health Technology Assessment dossier has ...

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Leading real world data and analytics organisations form industry coalition to advance policies to support regulatory use of real world evidence

19 May 2021 - RWE Alliance Launched by Aetion, Flatiron Health, IQVIA, Syapse, and Tempus. ...

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The pharma industry needs to measure patient experience from the patients’ perspectives

10 May 2021 - The relationship between clinical outcomes and the patient experience — the sum of all of interactions ...

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US, EU regulators discuss tailoring biosimilar approvals

11 May 2021 - A tailored approach to biosimilar approvals is conceived as the next big leap for regulatory advancement in ...

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The Government and Medicines Australia jointly agree to finalise patient centric strategic agreement after the Budget

8 May 2021 - Medicines Australia has been working closely with the Minister and his Department since last year to ...

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