News Archive

Medical Devices Notified Bodies Remote Auditing Survey

26th January 2021

Thanks to EUSurvey, the European Commission's tool, all Medical Devices Notified Bodies (n=54) received on September 28th, 2020, an invitation to the survey 'Notified Body Experience with Remote Auditing'. The survey was closed on October 29th. At that time, 37 Notified Bodies responded to the survey.

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EMA - SME and academia Clinical Trials Information System (CTIS) two-part training webinar

20th January 2021

The way clinical trials are conducted in the EU will undergo a major change when the Clinical Trial Regulation (Regulation (EU) No 536/2014) comes into application. The Regulation harmonises the assessment and supervision processes for clinical trials throughout the EU, via a Clinical Trials Information System (CTIS). CTIS will contain the centralised EU portal and database for clinical trials foreseen by the Regulation and will be used by clinical trial sponsors as a single entry point in the EU to obtain approval for clinical trials based on applications and for monitoring clinical trials during their life cycle, including the submission of summary of results.

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EMA - webinar for industry on OMS and RMS

20th January 2021

EMA is organising an webinar for industry on its Organisations Management Service (OMS) and Referentials Management Service (RMS) activities, on 03/02/2021 and 04/02/2021. While it is a general webinar, it will provide relevant information to sponsor organisations that will be using CTIS in future.

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New guidance and information for industry from the MHRA

4th January 2021

The transition period for the United Kingdom's departure from the EU is over and new guidance on a matter of topics has been released by the MHRA.

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EMA - Strategy to 2025

22nd December 2020

The strategy details how the European medicines regulatory network can continue to enable the supply of safe and effective medicines that meet patients’ needs in the face of challenges posed by ever-accelerating developments in science, medicine, digital technologies, globalisation as well as emerging health threats, such as the COVID-19 pandemic.

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GDP for APIs - New ECA/PQG Guide

22nd December 2020

The new 'Guidance on interpretation and implementation' of the ECA Foundation and the PQG of the CQI

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MHRA - Qualifications of suppliers and customers online: reliable or fake news?

22nd December 2020

A blog post by Emanuela Krasteva and Peter Brown, 21 December 2020

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EMA - Joint strategy sets direction for EMA and EU medicines regulatory agencies to 2025

15th December 2020

EMA and the Heads of Medicines Agencies (HMA) have published their joint strategy for the next five years, following its recent adoption by the HMA and EMA Management Board.

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