Regulatory Updates-November 2020
MHRA: Draft guidance on randomised controlled trials generating real-world evidence to support regulatory decisions Read more… Philippines FDA: Full implementation
Category: Regulatory Updates
Regulatory Updates-October 2020
Swissmedic: Changeover to electronic submission of notifications of major changes: 1 November 2020 Read more… FDA: The Use of Physiologically
Regulatory Updates-September 2020
FDA: Information about Nitrosamine Impurities in Medications Read More.. WHO: Corticosteroids for Covid-19 Read More.. MHRA post-transition period information –
Regulatory Updates-August 2020
FDA: Purple Book, lists of licensed biological products with reference product exclusivity and bio similarity or interchangeability evaluations Read More…
Regulatory Updates-July 2020
EMA: Questions and answers on regulatory expectations for medicinal products for human use during the covid-19 pandemic Read More… Swiss