FDA, EMA officials discuss impediments to cell and gene therapies

17 May 2022 - The US FDA's top biologics regulator said the use of a “playbook” or platform approach ...

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MHRA approves faricimab through international work-sharing initiative

17 May 2022 - It is the first treatment approved by the UK regulator that has been made possible through the ...

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European collaboration on health technology assessment: looking backward and forward

19 April 2022 - The establishment of health technology assessment has been an important topic in Europe for many years. ...

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Europe’s new HTA system spurs more debate, concern

12 April 2022 - Fresh round of discussions around health technology assessment. ...

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EMA and the EUnetHTA 21 consortium set priorities for their collaboration

12 April 2022 - The EMA and the European Network for Health Technology Assessment (EUnetHTA) 21 consortium have published a joint ...

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European medicines regulatory network adopts EU common standard for electronic product information

22 February 2022 - The European Medicines Regulatory Network has adopted a Common Standard for the electronic product information on medicines ...

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Mentoring as a potential means to assist consumer representatives contribute effectively to the assessment of health technologies in Australia: a pragmatic review

7 February 2022 - This project was implemented on behalf of the Health Technology Assessment Consumer Consultative Committee to explore training ...

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Health technology assessment of paediatric medicines: European landscape, challenges and opportunities inside the conect4children project

28 January 2022 - This article aims at describing the most relevant elements of the drug development process in the paediatric ...

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Building a model of health technology assessment co-operation: lessons learned from EUnetHTA joint action 3

28 January 2022 - The European Network for Health Technology Assessment (EUnetHTA) was established in 2006. During its final project phase ...

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Global regulators discuss path towards regulatory alignment on response to Omicron variant

13 January 2022 - On 12 January, regulators from around the world discussed the global regulatory response to the COVID-19 Omicron ...

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Health technology assessment: European Commission welcomes the adoption of new rules to improve access to innovative technologies

13 December 2021 - Today, the Regulation on Health Technology Assessment, a deliverable of the EU Pharmaceutical Strategy, has been adopted.  ...

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EU regulation passed: G-BA works on European HTA assessment

14 December 2021 -  Today the EU Parliament passed the EU-HTA regulation for a joint health technology assessment, which includes, ...

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Access Consortium statement on COVID-19 medicines

14 December 2021 - Vaccines have played a critical role in fighting the COVID-19 pandemic. However, medicines can still play ...

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ACCC helps to protect Australians against medicine shortages caused by COVID-19

10 December 2021 - Medicine shortages from the COVID-19 pandemic will continue to be actively managed by Medicines Australia and ...

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International regulators stress continued need for COVID-19 therapeutics

11 December 2021 - EMA has endorsed a statement by the International Coalition of Medicines Regulatory Authorities that urges all ...

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