QVigilance Blog & Regulatory Updates

  • EU Regulation
  • Brexit News
  • Brexit Updates
  • PSMF

Updated guidance on QPPV and PSMF requirements from 01 Jan 2021

The United Kingdom (UK) formally left the European Union (EU) on 31 January 2020, since then, there has been a ...

  • Brexit News
  • Brexit Updates

UK Government publishes updated pharmacovigilance guidance for UK medicines

The United Kingdom (UK) formally left the European Union (EU) on 31 January 2020 and since that time has been in a ...

  • Pharmacovigilance Blog
  • GVP

What you need to know about the GVP Paediatric Guideline

The Good Pharmacovigilance Practice (GVP) Guideline 'Product- or Population-Specific Considerations IV: Paediatric ...

  • Pharmacovigilance Blog

A Guide to the US FDA Safety Requirements for Pharmacovigilance

To ensure a smooth transition from the pre-authorisation to the post-authorisation phase of the life-cycle of a ...

  • Brexit News

MHRA e-Submission Update in preparation for Brexit

The Medicines and Healthcare products Regulatory Agency (MHRA) have released guidance on how to make regulatory ...

  • Regulatory Intelligence

Health Canada: Discontinuation of Acknowledgement Letters for Regulatory Activities

On 30th Jan 2019, Health Canada issued a notice that effective from 01st April 2019, it will discontinue issuing ...

  • Pharmacovigilance Blog
  • Brexit News

Brexit and Pharmacovigilance considerations: UK Draft contingency legislation released

The UK government has released draft legislation amending the regulation of authorised Medicinal Products, Medical ...

  • Regulatory Intelligence

‘No deal’ Brexit regulatory advice on medicines, devices and clinical trials

In this 'Brexit News' close-up our Regulatory Intelligence team will provide a commentary and updates on recent British ...

  • Pharmacovigilance Blog

Pharmacovigilance in the European Union (EU): Preparing for Authorisation of your Medicinal Product

To ensure a smooth transition from the pre-authorisation to the post-authorisation phase of the life-cycle of a ...