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International regulatory news in brief

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This post covers international regulatory news in brief. It will be updated on an ad hoc basis. For ease of navigation, a tab has been added for each region (below). Click on the respective tab to view the news for…

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  • 25 May 2022
  • CMDh updates, European Union

CMDh and other updates – April 2022

EU flag

Last updated: 25 May 2022 Updates are detailed at the end of this post. Report and minutes from the CMDh meeting held on 20-21 April 2022 The following four items (i – iv) are included in the report and minutes…

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  • 25 May 2022
  • COVID-19

COVID-19 vaccines and treatments, regulatory status at a glance (3 of 3)

The table below shows the COVID-19 vaccines and treatments regulatory status at a glance. It is updated on an ad hoc basis. Regulatory status from 14 April 2022 is covered. On mobile, the table is best viewed by scrolling sideways.…

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  • 24 May 2022
  • Guidance for industry, US FDA

US FDA issued guidance for industry, April – June 2022

On mobile, the table below is best viewed by scrolling sideways. Title of guidance Type and level of guidance About the guidance Source Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases –…

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  • 24 May 2022
  • European Union, Medical Devices, Medical Devices Coordination Group

MDCG updates: April – June 2022

The Medical Device Coordination Group (MDCG) has published the following updates: Guidance No About the guidance MDCG 2022-9 Summary of safety and performance Template Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the IVDR) requires that the manufacturer shall…

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  • 24 May 2022
  • COVID-19, News in brief

Pandemic related news in brief (including vaccines, drugs, trials, side effects etc.)

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23 May Three shots of low-dose vaccine generates ‘strong immune response’ in kids under 5, says Pfizer Pfizer and BioNTech said they will ask the US FDA to authorise a three-shot regimen of their Covid-19 vaccine for children under five…

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  • 23 May 2022
  • Important dates in regulatory calendar

Some important regulatory dates in the calendar

Last updated: 23 May 2022 Some Important dates in the calendar, from a regulatory perspective, are provided in the tables below. This post will be updated on an ad hoc basis. On mobile, the tables are best viewed by scrolling…

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  • 23 May 2022
  • CMDh updates, European Union

CMDh and other updates – May 2022

EU flag

Pharmaceutical committee meeting of 11 May The 99th meeting of the committee was held on 11 May. Whilst a summary record of the meeting is not yet available, it is worthwhile viewing the agenda and the document for discussion. The…

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  • 17 May 2022
  • Clinical trials

An information resource for the EU Clinical Trials Regulation

Inage of healthcare professional and patient

This post is an attempt to provide an information resource for the Clinical Trials Regulation (EU) no 536/2014 (CTR). The information provided is by no means exhaustive. Click on the ‘+’ sign next to each heading to access the information…

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  • 11 May 2022
  • European Medicines Agency, Paediatric Investigation Plans

EU Paediatric Investigation Plans (PIPs), the basics

This post is an attempt to provide basic information about paediatric investigation plans (PIPs) in the EU. The information provided is by no means exhaustive. Click on the ‘+’ sign next to each heading to access the information under each…

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  • 3 May 2022
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