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EMA - Phasing out of extraordinary COVID-19 regulatory flexibilities

19th July 2023

EMA, the European Commission (EC) and the Heads of Medicines Agencies (HMA) are phasing out the extraordinary regulatory flexibilities for medicines put in place during the COVID-19 pandemic to help address regulatory and supply challenges arising from the pandemic. This follows the end of the COVID-19 public health emergency declared by WHO in May 2023.

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FDA - Roundup of Agency Events

19th July 2023

18th July 2023

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MHRA - Lists of products using derogations under the European Commission Directive 2022/642 Updated

19th July 2023

Lists of products using derogations under the European Commission Directive 2022/642

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MHRA - MHRA launches public consultation on reclassification of opioid-containing cough medicine

19th July 2023

Health professionals and the public have until 15 August to share their views on the potential reclassification of codeine linctus to a prescription-only medicine.

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MHRA - Thousands of unlicensed medical products seized in morning of raids in Bolton

19th July 2023

MHRA Criminal Enforcement Unit (CEU) seized a quantity of suspected unlicensed medical products following coordinated raids at three residential and six business premises in Bolton, Greater Manchester.

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EMA - Veterinary Awareness Day

10th July 2023

The EMA is organising its first-ever EMA Veterinary Awareness Day to be held on 12 and 13 September 2023.

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EMA - ACT EU: creating a better environment for clinical trials through collaboration

5th July 2023

ACT EU initiative is today organising the kick-off workshop for a new multi-stakeholder platform to improve clinical trials in the European Union (EU).

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EMA - Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)

5th July 2023

19-22 June 2023

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FDA Roundup - 30th June 2023

5th July 2023

An at-a-glance summary of news from around the agency:

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ICH - Reflection Paper on Harmonisation of RWE Terminology available for public consultation

5th July 2023

This Reflection Paper was endorsed by the Assembly in June 2023.

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