International – E6(R3): ICH releases draft of overhauled GCP guideline for consultation

The International Council for Harmonisation (ICH) on Tuesday published the long-awaited draft version of its ICH E6(R3) guideline on good clinical practice (GCP) for...

USA – FDA drafts guidance on using ‘generally accepted’ knowledge to support drug approvals

The US Food and Drug Administration (FDA) on Wednesday issued draft guidance offering examples of how drug sponsors can rely on generally accepted scientific...

Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)...

Two new medicines recommended for approval EMA’s human medicines committee (CHMP) recommended two medicines for approval at its May 2023 meeting. The committee recommended granting a marketing...

Europe – EMA recommends revocation of authorisation for sickle cell disease medicine Adakveo

EMA’s human medicines committee (CHMP) has recommended revoking the marketing authorisation for Adakveo (crizanlizumab), a medicine for preventing painful crises (called vaso-occlusive crises) in patients aged...
Advice for Management of Clinical trials in relation to Coronavirus

UK – SKYCovion COVID-19 vaccine authorised by MHRA

SKYCovion, the COVID-19 vaccine developed by SK Chemicals, has today been authorised by the Medicines and Healthcare products Regulatory Agency (MHRA). It becomes the 8th...
Advice for Management of Clinical trials in relation to Coronavirus

UK – MHRA announces new recognition routes to facilitate safe access to new medicines...

New regulatory recognition routes for medicines will be established using approvals from Australia, Canada, the European Union, Japan, Switzerland, Singapore and the United States,...
Topical Drug Products for Cutaneous Application: Human Safety Assessment Guidance

USA – FDA Approves First Oral Antiviral for Treatment of COVID-19 in Adults

Today, the U.S. Food and Drug Administration approved the oral antiviral Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment...
MHRA Offers Grace Period for Device Manufacturers Dealing With Withdrawn Notified Bodies

UK – Regulatory approval of Pfizer/BioNTech vaccine for COVID-19

There are four presentations of the original COVID-19 Vaccine Pfizer/BioNTech authorised for use in Great Britain, three of which are currently available and all...
ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials

International – ICH S5 (R3) Guideline on detection of reproductive and developmental toxicity for...

The purpose of this document is to recommend international standards for, and promote harmonization of, the assessment of nonclinical developmental and reproductive toxicity (DART)...

USA – FDA Approves Prescription Nasal Spray to Reverse Opioid Overdose

Today, the U.S. Food and Drug Administration approved Opvee, the first nalmefene hydrochloride nasal spray for the emergency treatment of known or suspected opioid...

NOS PROCHAINES FORMATIONS