News Archive

Notice to sponsors on validation and qualification of computerised systems used in clinical trials

1st May 2020

Note: This notice should be read in conjunction with Q8 and Q9 from the good clinical practice (GCP) Q&As published on the EMA website: https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-clinicalpractice/qa-good-clinical-practice-gcp

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Coronavirus: EC issues guidance to mitigate clinical trial disruption

28th April 2020

Today, the European Commission has published guidance to ensure that clinical trials can continue taking place in the EU during the COVID-19 pandemic.....

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Delayed implementation of MDR

27th April 2020

The European Parliament and Council have approved a proposal to delay the full implementation of the Medical Device Regulation 2017/745 (MDR) for one year to 26 May 2021. This means that the full applicability of the MDR will fall outside of the transition period agreed with the EU.

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MRC Regulatory Support Centre COVID-19 Bulletin

27th April 2020

The COVID-19 pandemic has significantly impacted health research as it has every aspect of our lives. In this bulletin we pull together information about the special research governance arrangements currently in place to help tackle the pandemic. Many of these arrangements will be temporary.

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Exceptional GMP flexibilities for medicines manufacturers during the coronavirus (COVID-19) outbreak

22nd April 2020

These temporary good manufacturing practice (GMP) flexibilities will be allowed to address the current exceptional circumstances

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EMA - Update to guidance on regulatory expectations in the context of COVID-19 pandemic

20th April 2020

The European Commission, EMA and the national competent authorities have agreed a series of measures to mitigate the impact of disruptions caused by COVID-19 on the conduct of inspections of manufacturing facilities or other sites relevant for medicinal products in the European Union.

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Pharmacovigilance Inspection Metrics April 2018 to March 2019

20th April 2020

The MHRA GPvP inspectorate recently published their latest inspection metrics for the period from April 2018 to March 2019. The full metrics report is available on GOV.UK.

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MedDRA Version 23.0 Update to be Produced

15th April 2020

The ICH MedDRA Management Committee has decided to provide the new COVID-19 terms within the MedDRA dictionary in a very expedited fashion, given the current very exceptional time with the COVID-19 pandemic demanding flexible approaches to ensure that any scientific and medical information from the COVID-19 outbreak can be captured, shared and analysed appropriately.

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Guidance on regulatory requirements in the context of the COVID-19 pandemic

14th April 2020

The European Commission, EMA and the European medicines regulatory network have developed a question-and-answer (Q&A) document to provide guidance to stakeholders on adaptations to the regulatory framework to address challenges arising from the COVID-19 pandemic, with a particular focus on crucial medicines for use in COVID-19 patients.

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MHRA New opportunities to submitting your proposals for test kits, even when your proposals don't meet our specifications.

14th April 2020

Guidance on coronavirus (COVID-19) tests and testing kits - updated with new opportunities to submitting your proposals for test kits, even when your proposals don't meet our specifications.

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