From their meeting in March, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights. Read more “Highlights from the March CHMP meeting 2020”
Category: Medicinal product
UK calls for mutual recognition of GMP certificates in Brexit negotiations
After the end of the Brexit transition period, UK officials are seeking provisions to facilitate trade in medicinal products between the UK and EU, proposing that each side recognise good manufacturing practice (GMP) certificated issues by each other. Read more “UK calls for mutual recognition of GMP certificates in Brexit negotiations”
Highlights from the February CHMP meeting 2020
From their meeting in February, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights. Read more “Highlights from the February CHMP meeting 2020”
Are you aware that the ICH M9 guidance on BCS based bio-waivers will take effect in July?
The new guidelines provide recommendations to support the biopharmaceutics classification of drug substances and the Biopharmaceutics Classification System (BCS) based bio-waiver approach. Read more “Are you aware that the ICH M9 guidance on BCS based bio-waivers will take effect in July?”
UK government introduces post-Brexit medicines and medical device bill
In a post-Brexit overhaul, the UK government has introduced a human and veterinary medicines, clinical trials and medical devices bill, which could alter the regulatory framework at the end of the transition period. Read more “UK government introduces post-Brexit medicines and medical device bill”
FDA issues emergency use authorisation for their first 2019 novel coronavirus diagnostic
The Centres for Disease Control and Prevention’s (CDC) 2019-nCov Real-Time RT-PCR Diagnostic Panel has been approved for use across the US. Read more “FDA issues emergency use authorisation for their first 2019 novel coronavirus diagnostic”
Highlights from the January CHMP meeting 2020
From their meeting in January, The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights. Read more “Highlights from the January CHMP meeting 2020”
A harmonised approach to electronic product information (ePI)
In 2017, the European Commission (EC) identified electronic product information (ePI) as a means of improving how EU citizens access information about medicines. They have now released a set of principles to harmonise this approach. Read more “A harmonised approach to electronic product information (ePI)”
Clinical and in-vitro studies for potential drug-drug interactions
The US Food and Drug Administration (FDA) have finalised two guidances which provide recommendations to drug developers on how to evaluate drug-drug interactions (DDI) for investigational new drugs (IND), through in-vitro and clinical studies. Read more “Clinical and in-vitro studies for potential drug-drug interactions”
WHO warns that lack of new antibiotic drug development is threatening the fight against drug-resistant bacteria
“The threat of antimicrobial resistance has never been more immediate and the need for solutions more urgent.” Read more “WHO warns that lack of new antibiotic drug development is threatening the fight against drug-resistant bacteria”