Europe – Treatments and vaccines for COVID-19
Update: On 3 July 2020, the European Commission granted a conditional marketing authorisation for remdesivir, for the treatment of COVID-19 in adults and adolescents from 12 years of...
Europe – Guidance for medicine developers and companies on COVID-19
EMA encourages developers of potential vaccines or treatments for COVID-19 to contact EMA as soon as possible to discuss their strategy for evidence-generation.
They should email their...
Europe – Clinical Trials Information System (CTIS) highlights – June 2020
The implementation of the Clinical Trial Regulation (Regulation (EU) No 536/2014) (CTR) will bring a major change in the authorisation, conduct, supervision and reporting...
Europe – ICH guideline M7 on assessment and control of DNA reactive (mutagenic) impurities...
Since the ICH M7 Guideline was finalized, worldwide experience with implementation of the recommendations for DNA reactive (mutagenic) impurities has given rise to requests...
International – Ethnic Differences, Regulatory Policies, and COVID-19
The ICH E5 guideline “Ethnic factors in the acceptability of foreign clinical data” and E17 guideline “General principles for planning and design of multi-regional clinical trials” present harmonized...
International – Global Electronic Labeling Initiatives: Updates from Japan, Canada, Europe, US, and Asia
Electronic labeling is the focus of many ongoing initiatives across regions. E-labeling can deliver the latest labeling information immediately and in an efficient and...
International – Improving Access to CAR T Therapy: It’s Not Just Payment
The development of chimeric antigen receptor (CAR) T therapy for patients with advanced hematological malignancies represents one of the greatest successes in bringing basic...
USA – A compilation of FDA COVID-19-related guidelines
From the beginning of the coronavirus (COVID-19) pandemic, FDA actively provided guidance to members of the drug and biologic industries, including sponsors, investigators, pharmacies,...
Europe – International regulators provide guiding principles for COVID-19 clinical trials
EMA has endorsed a joint statement on prioritisation of COVID-19 clinical trials published by the International Coalition of Medicines Regulatory Authorities (ICMRA). Medicines regulators from around...
Europe – EU agencies clarify pharmacovigilance expectations amid COVID-19
In an update to their joint questions and answers document on regulatory expectations for medicinal products amid the coronavirus disease (COVID-19) pandemic, the European...
