An EU wide approach to HTA: an irrelevant development or an opportunity not to be missed?

14 March 2019 - An EU-wide cooperation on HTA has been proposed recently by the European Commission, focusing on relative effectiveness ...

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Two additional countries to benefit from EU-US mutual recognition agreement for inspections

11 February 2019 - In February 2019, the US FDA confirmed the capability of two additional European Union Member States ...

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NICE collaborates with the Canadian Agency for Drugs and Technology in Health to offer parallel scientific advice

6 February 2019 - NICE and the Canadian Agency for Drugs and Technology in Health have launched a new collaboration to ...

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New opportunity: parallel scientific advice from CADTH and NICE

6 February 2019 - CADTH is pleased to announce a new collaboration with England’s NICE (National Institute for Health and ...

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ICER launches international collaborative to develop new methods to guide value-based pricing of potential cures

23 January 2019 - NICE in the UK and CADTH in Canada among international agencies participating; public input on key methodological ...

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Our door is open: FDA puts patients first

18 December 2018 - We believe patients are experts when it comes to their health conditions.  ...

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FDA announces pilot program with WHO to expedite review of HIV drug applications

30 November 2018 - The U.S. FDA today announced a plan to work with the WHO to pilot a process to ...

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Comparable overseas reports pathway - first registration decision

2 November 2018 - Cabozantinib (Cabometyx) is the first medicine to be registered on the Australian Register of Therapeutic Goods ...

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Update on the Australia-Canada Mutual Recognition Agreement

1 November 2018 - Common Statement regarding inclusion of Active Pharmaceutical Ingredient in Australia-Canada Mutual Recognition Agreement (as of November 1, ...

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FDA and DHS increase coordination of responses to medical device cybersecurity threats under new partnership; a part of the two agencies’ broader effort to protect patient safety

16 October 2018 - As part of the Administration’s ongoing efforts to strengthen cybersecurity in health care, the U.S. FDA ...

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Early dialogue in Europe: perspectives on value, challenges, and continuing evolution

24 September 2018 - This study aims to assess participants’ views on previous experiences, the current situation and future perspectives for ...

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Portugal to also benefit from EU-US mutual recognition agreement for inspections

20 September 2018 - Agreement now operational between 15 EU Member States and FDA. ...

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Australia unveils strategy for engaging with foreign regulators

17 September 2018 - Australia’s TGA revealed a three-part plan on Monday to operationalise its strategy on engaging international regulators ...

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TGA international engagement strategy: operations plan 2018-19

17 September 2018 - To support Australian regulatory decisions the TGA considers international reports and evaluations, monitor early warnings and ...

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Dutch, Swiss regulators forge agreement on data exchange

14 September 2018 - The heads of the Netherland’s Medicines Evaluation Board and Swissmedic have signed a memorandum of understanding ...

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