News Archive

EMA - COVID-19 Vaccines

2nd December 2020

The European Medicines Agency has published information on the development and evaluation of vaccines for COVID-19.

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EMA - Consideration on core requirements for RMPs of COVID19 vaccines

1st December 2020

Consideration on core requirements for RMPs of COVID19 vaccines coreRMP19 guidance Introduction/Background In addition to the EMA guidance on pharmacovigilance and vaccine development, the EMA will issue the “Pharmacovigilance Plan of the EU Regulatory Network for COVID-19 Vaccines” giving an overview of the monitoring activities to be carried out in the EU for COVID-19 vaccines, including the roles, responsibilities and interactions of the stakeholders involved. Further interactions between EMA, NCAs, and the vaccine manufacturers have identified the need to develop further guidance on RMP requirements for COVID-19 vaccines.

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EMA - November 2020 PRAC Highlights

1st December 2020

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 23-26 November 2020

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EMA - Pharmacovigilance Plan of the EU Regulatory Network for COVID-19 Vaccines

1st December 2020

Pharmacovigilance Plan of the EU Regulatory Network for COVID-19 Vaccines

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EMA publishes safety monitoring plan and guidance on risk management planning for COVID-19 vaccines

1st December 2020

EMA and the national competent authorities (NCAs) in EU Member States have prepared a  safety monitoring plan for COVID-19 vaccines . The plan outlines how relevant new information emerging after the authorisation and uptake of COVID-19 vaccines in the pandemic situation will be collected and promptly reviewed.

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MHRA - Guidance on pharmacovigilance procedures from 1 January 2021

1st December 2020

Content added to Section 2.2, covering the country codes and worldwide case IDs which should be used.

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MHRA - On-site access to Electronic Health Records by Sponsor representatives in clinical trials

1st December 2020

On-site access to Electronic Health Records by Sponsor representatives in clinical trials The following guidance has been jointly developed by the Heath Research Authority (HRA) and MHRA, in consultation with the Information Commissioners Office (ICO), on behalf of the UK.

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MRC Regulatory Support Centre Research Governance Survey Report

1st December 2020

MRC Regulatory Support Centre Research Governance Survey Report November 2020

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EMA organises public meeting on COVID-19 vaccines

30th November 2020

EMA will organise a public meeting on 11 December 2020 to inform European citizens about the EU regulatory processes for the approval of COVID-19 vaccines and the Agency’s role in their development, evaluation, approval and safety monitoring.

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Visit Europe from 1 January 2021

30th November 2020

As well as the actions all travellers need to take, there are extra actions if you’re travelling to the EU for business. Business travel includes activities such as travelling for meetings and conferences, providing services (even with a charity), and touring art or music.

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