Ensuring patient safety and drug manufacturing quality through partnership with European Union regulators

11 July 2019 - The Mutual Recognition Agreement with the European Union allows FDA to more effectively deploy our inspectional resources ...

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Guido Rasi elected chair of International Coalition of Medicines Regulatory Authorities

8 July 2019 - The International Coalition of Medicines Regulatory Authorities has elected EMA’s Executive Director Guido Rasi as its ...

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International work-sharing Initiative - niraparib (Zejula)

1 July 2019 - The TGA has approved a new drug for the treatment of some ovarian, fallopian tube, or ...

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Incorporating patient preferences in non-inferiority trials

24 June 2019 - Non-inferiority trials imply a trade-off between a loss in efficacy of a standard treatment in exchange for ...

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

11 June 2019 - On 10 June 2019, Luxembourg and the Netherlands were included into the mutual recognition agreement between ...

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Strengthening engagement between EMA and general practitioners

6 June 2019 - EMA and the two major organisations representing general practitioners (GPs) and family physicians in Europe – ...

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Campaign wants patients to have more influence on PBS

3 June 2019 - Australian patients should be given greater say in the medicines that receive government reimbursement as consumers ...

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EMA facilitates early engagement with medicine developers to combat antimicrobial resistance

24 May 2019 - As of today, EMA is opening up the early dialogue available through its Innovation Task Force ...

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Health Technology Assessment Consumer Consultative Committee March 2019 meeting communiqué

20 May 2019 - A communiqué from the March 2019 meeting of the HTA Consumer Consultative Committee has been published. ...

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Health Canada approves new drug to treat metastatic breast cancer through international and domestic joint reviews

9 April 2019 - Canadians want improved access to the most recent and innovative treatment options for themselves and their ...

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International work-sharing initiative - abemaciclib (Verzenio)

9 April 2019 - Abemaciclib (Verzenio) is the second medicine to be registered on the Australian Register of Therapeutic Goods ...

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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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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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