The European Medicines Agency (EMA) has laid out its COVID-19 vaccine safety monitoring plan, as it continues a rolling review of vaccine candidates. Read more “EMA lays out COVID-19 vaccine pharmacovigilance plan”
News
Highlights from the November CHMP meeting 2020
From their meeting in November, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights. Read more “Highlights from the November CHMP meeting 2020”
MHRA guidance on generating real-world evidence in clinical trials
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published draft guidance on randomised controlled trials (RCT) generating real-world evidence (RWE) to support regulatory decisions. Read more “MHRA guidance on generating real-world evidence in clinical trials”
What is the new UKNI marking for medical devices?
Find out more about the new UKNI marking for medical devices being placed on the Northern Ireland (NI) market. Read more “What is the new UKNI marking for medical devices?”
Revised guidance on ICSRs in the context of COVID-19
The European Medicines Agency (EMA) have updated their guidance on the validity and coding of Incident Case Safety Reports (ICSR) in the context of COVID-19 related terms. Read more “Revised guidance on ICSRs in the context of COVID-19”
EMA encourages companies to submit type I variations for 2020 by end of November
The European Medicines Agency (EMA) has advised marketing authorisation holders (MAH) to submit type IA and type IAIN variations for 2020 no later than Monday 30 November 2020. Read more “EMA encourages companies to submit type I variations for 2020 by end of November”
Referencing approved drug products in ANDA submissions
In a finalised guidance, the US Food and Drug Administration (FDA) has given generic drug developers further information about how to identify reference listed drugs (RLD), reference standards and abbreviated new drug application (ANDA) submissions. Read more “Referencing approved drug products in ANDA submissions”
Catch the latest updates to the MHRA transition period guidances
The Medicines and Healthcare products Regulatory Agency (MHRA) has published further guidance and updates in relation to supplying medicines and medical devices after the end of the transition period. Read more “Catch the latest updates to the MHRA transition period guidances”
EMA guidance on scientific advice and protocol assistance
The European Medicines Agency (EMA) have released a guidance document addressing a number of questions that users of the scientific advice or protocol assistance procedures may have. Read more “EMA guidance on scientific advice and protocol assistance”
UK MHRA to join the Australia-Canada-Singapore-Switzerland (ACSS) Consortium
From 01 January 2021, pharmaceutical companies that submit applications to some or all of the five countries will benefit from having their products evaluated for marketing in those countries simultaneously with reduced evaluation times. Read more “UK MHRA to join the Australia-Canada-Singapore-Switzerland (ACSS) Consortium”