Guidance for industry to prevent and mitigate medicine shortages

17 May 2023 - EMA has published recommendations for industry on good practices to ensure continuity in the supply of ...

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Facilitating decentralised clinical trials in the EU

19 December 2022 - The European Commission, the Heads of Medicines Agencies and the EMA have published recommendations that aim to ...

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EMA pilot offers enhanced support to academic and non-profit developers of advanced therapy medicinal products

29 September 2022 - EMA is launching a pilot to support the translation of basic research developments into medicines that could ...

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EMA finalises companion diagnostic guidance

7 July 2022 - The EMA) has finalised guidance on companion diagnostics, addressing procedural aspects to facilitate consultation between EMA ...

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EMA guidance supports development of new antibiotics

24 May 2022 - As part of its efforts to support a global approach to the development of new antimicrobial medicines, ...

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Adapting COVID-19 vaccines to SARS-CoV-2 variants: guidance for vaccine manufacturers

25 February 2021 - EMA has issued guidance outlining the requirements for manufacturers planning to modify their COVID-19 vaccines in ...

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New toolbox available for EMA's PRIME designees

2 February 2021 - The European Medicines Agency has released a draft guidance to assist drug developers using its Priority ...

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EMA close to finalising guidance for advanced therapies

16 September 2020 - The European Medicines Agency is on the verge of releasing revised guidance for advanced therapy medicinal ...

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International regulators provide guiding principles for COVID-19 clinical trials

1 July 2020 - EMA has endorsed a joint statement on prioritisation of COVID-19 clinical trials published by the International ...

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Global regulators map out data requirements for phase 1 COVID-19 vaccine trials

24 March 2020 - Global regulators have published a report today presenting the outcomes of a workshop on COVID-19 vaccine ...

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Beyond “Intent‐to‐treat” and “Per protocol”: improving assessment of treatment effects in clinical trials through the specification of an estimand

27 December 2019 - There is a key problem in randomised clinical trials as outcomes can be distorted due to ...

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EMA offers edits on FDA draft guidance on biosimilars

29 August 2019 - Although regulators rarely offer public comments on another regulator’s guidance, the European Medicines Agency (EMA) late ...

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Consultation on draft guideline on quality requirements for medical devices in combination products

3 June 2019 - EMA has released a draft guideline on the quality requirements for medical devices in human medicines ...

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Minimal residual disease as a surrogate outcome for product development for multiple myeloma: comparing FDA and EMA guidances

8 April 2019 - This article discusses the need to update regulatory science to include the use of minimal residual disease ...

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Revised guideline aims to strengthen global approach to development of new antibacterial medicines

14 January 2019 - EMA has published a PDF revision of its guideline on the evaluation of human medicines ...

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