News Archive

EMA - Update on COVID-19 Vaccines

23rd February 2021

EMA Update on COVID-19 Vaccines

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EMA - public stakeholders meeting on the approval, safety monitoring and impact of COVID-19 vaccines in the EU

23rd February 2021

There is a third EMA public stakeholder meeting on the approval, safety monitoring and impact of COVID-19 vaccines in the EU to be held virtually on 26 March 2021 from 13:00 to 15:15 CET.

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MHRA - registration on the MHRA Submissions Portal

23rd February 2021

How to apply for marketing authorisation via this new procedure. MHRA have updated how to receive a 5 digit company number.

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EMA - Q&A - post-authorisation procedural advice for users of the centralised procedure

17th February 2021

Questions and answers are being updated continuously and will be marked by “NEW” or “Rev.” with the relevant date upon publication. This guidance document addresses a number of questions which marketing authorisation holders (MAHs) may have on post-authorisation procedures. It provides an overview of the Agency’s position on issues, which are typically addressed in discussions or meetings with MAHs in the post-authorisation phase

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HMA - CMDh - Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP

17th February 2021

The below Practical Guidance aims to provide procedural and practical guidance regarding submission of changes. It addresses the implications of the withdrawal agreement and the transition period provided for therein.

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MHRA - Guidance on pharmacovigilance requirements for UK authorised products from 1 January 2021

12th February 2021

MHRA have been working hard to provide the guidance you need to become familiar with the pharmacovigilance requirements for UK marketing authorisation holders (MAH) which are set out in a revised legal framework.

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Clinical Trials Information System (CTIS): training programme

11th February 2021

Training is available from the European Medicines Agency (EMA) on how to use the Clinical Trials Information System (CTIS) ahead of its planned launch. EMA’s training resources are tailored for clinical trial sponsors and staff of the European Union (EU) Member States, European Commission and other organisations who will use the system. The training materials aim to help users comply with their obligations under the Clinical Trial Regulation (Regulation (EU) No 536/2014), which apply once the CTIS goes live. More information on the CTIS and the Clinical Trial Regulation is available on Clinical Trial Regulation.

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EMA - Draft Toolbox for Consultation

5th February 2021

The European Medicines Agency has published for public consultation a draft toolbox guidance on scientific elements and regulatory tools to support quality data packages for PRIME marketing authorisation applications.

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EMA - GVP Guidelines for Consultation

5th February 2021

Guideline on good pharmacovigilance practices (GVP) - Module XVI – Risk minimisation measures: selection of tools and effectiveness indicators (Rev 3) and Guideline on good pharmacovigilance practices (GVP) - Module XVI Addendum II – Methods for effectiveness evaluation

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MHRA Blog Post: Reference Safety Information (RSI) for Clinical Trials- Part III

5th February 2021

Since RSI blog posts part I and II were released, the MHRA GCP inspectorate has continued to see non-compliance in this key aspect of pharmacovigilance. Whilst additional guidance was released by the Heads of Medicines Agencies, Clinical Trials Facilitation and co-ordination Group (CTFG), we are still seeing unreported suspected unexpected serious adverse reactions (SUSARs) and absence of adequate risk mitigation measures due to incorrect use of the RSI.

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