Guidance on Remote GCP Inspections During the COVID-19 Pandemic
On 10 June 2020 the EMA announced that guidance is available for inspectors on how to initiate and conduct remote inspections to verify compliance with GCP standards during the COVID-19 pandemic.
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EMA Annual Report 2019 Published
On 15 June 2020 the EMA released its annual report highlighting the most significant achievements in 2019.
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European Medicines Agency Post-authorisation Procedural Advice for Users of the Centralised Procedure
On 18 May 2020 the EMA updated the questions and answers on extensions of marketing authorisations.
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Summary of Stakeholder Engagement to Support the Development of ICH E6(R3)
On 18 May 2020 the ICH announced the availability of the summary of the E6(3) stakeholder engagement approach.
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EMA Updates EudraVigilance Registration Manual
On 18 May 2020 the EMA updated the EudraVigilance registration manual.
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