Digital Health and Pharma 4.0 - Mark Birse

7th November 2019

Digital Health and Pharma 4.0, Mark Birse. MHRA Blog.

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Official Statistics - GMP Inspection deficiencies 2018

7th November 2019

Good manufacturing practice inspection deficiencies - Added MHRA GDP Inspection Deficiency Data 2018.

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Pharmacovigilance Risk Assessment Committee (PRAC)

7th November 2019

Meeting Highlights

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Chinese Authorities visit EMA to discuss GCP and GMP

29th October 2019

The Deputy Commissioner of the Chinese National Medical Product Administration (NMPA), Dr Chen Shifei, visited EMA on 25 October together with a delegation.

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EMA Management Board

9th October 2019

Highlights of October 2019 meeting

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MHRA Process Licensing: useful information

9th October 2019

New MHRA Blog post.

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No-deal Brexit - update to GCP, PV and GMP/GDP

9th October 2019

A line was added to the GCP, PV and GMP/GDP pages, risk-based inspection programmes will remain unchanged

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Webinars: preparing to make submissions to the MHRA after Brexit

9th October 2019

Webinars for pharmaceutical companies, clinical trial sponsors, e-cigarette producers and brokers of medicinal products about new MHRA systems you’ll need to use if there’s a no-deal Brexit.

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ICH Good Clinical Practice Guidelines (ICH E6) - Open Comment Opportunity - Deadline: 18 October 2019

7th October 2019

As a follow-up to the survey on the renovation of the ICH Good Clinical Practice Guidelines (ICH E6) conducted in August, the Clinical Trials Transformation Initiative (CTTI) has launched a new open comment opportunity which enables specific comments to be collected. Findings will be provided to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) for their consideration. Professionals involved in research for regulatory purposes are invited to provide comments as an individual or an organisation. Please complete the survey (only available in English) by 18 October 2019 using the following link: https://duke.qualtrics.com/jfe/form/SV_a2XzYMfecEgIjsx Please note that this activity is not anonymous, your name and affiliation, together with your comments, will be linked and provided to ICH. You have received this mail because you have registered in the EMA stakeholders database and subscribed to receive this kind of information. However, if you no longer wish to receive such communications from us, please send an email to StakeholdersDB@ema.europa.eu to unsubscribe. We would be grateful if you could disseminate this email to anyone else who might be interested in this information. With kind regards, Nathalie Macle Public Engagement Department Stakeholders and Communication Department stakeholdersDB@ema.europa.eu | www.ema.europa.euAs a follow-up to the survey on the renovation of the ICH Good Clinical Practice Guidelines (ICH E6) conducted in August, the Clinical Trials Transformation Initiative (CTTI) has launched a new open comment opportunity which enables specific comments to be collected. Findings will be provided to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) for their consideration. Professionals involved in research for regulatory purposes are invited to provide comments as an individual or an organisation. Please complete the survey (only available in English) by 18 October 2019 using the following link: https://duke.qualtrics.com/jfe/form/SV_a2XzYMfecEgIjsx Please note that this activity is not anonymous, your name and affiliation, together with your comments, will be linked and provided to ICH.

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MHRA Christmas 2019 Notifications

1st October 2019

MHRA have updated the Christmas 2019 notice period. Manufacturers are advised that MHRA will not be accepting notifications for clinical investigation or study amendments during the period 14 December 2019 – 1 January 2020 (inclusive). Any notifications received during this period will be processed in the new year and the 60 day assessment periods will start from 3 January 2020 for valid clinical investigation notifications. Any notifications received before 14 December 2019 will be processed as normal and there will be no interruption to the 60 day process over the Christmas period for these notifications.

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