European Medicines Agency releases new draft good pharmacovigilance practice guidance on pregnancy prevention programmes…
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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…
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…
What you need to know about the GVP Paediatric Guideline
The Good Pharmacovigilance Practice (GVP) Guideline ‘Product- or Population-Specific Considerations IV: Paediatric…
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 medicinal…
MHRA e-Submission Update in preparation for Brexit
The Medicines and Healthcare products Regulatory Agency (MHRA) have released guidance on how to make regulatory…
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…
Brexit and Pharmacovigilance considerations: UK Draft contingency legislation released
The UK government has released draft legislation amending the regulation of authorised Medicinal Products, Medical Devices…
‘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…
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 medicinal…