Europe – EMA finalises opinion on presence of nitrosamines in medicines
EMA’s human medicines committee (CHMP) has issued an opinion requiring companies to take measures to limit the presence of nitrosamines in human medicines as...
International – International regulators align positions on phase 3 COVID-19 vaccine trials
Medicines regulatory authorities from around the world have published a report today highlighting the outcomes of the second workshop on COVID-19 vaccine development that was convened...
UK – NICE backing for Takeda’s Adcetris for rare lymphoma
The decision allows NHS funding for the drug alongside cyclophosphamide, doxorubicin and prednisone (CHP), giving patients access to the first new front-line treatment option...
Europe – Launch of public consultation on joint network strategy to 2025
EMA and the Heads of Medicines Agencies (HMA) have developed a joint strategy for the next five years that is released for a two-month public consultation today. The...
UK – Britain closes in on £500m COVID-19 vaccine deal with Sanofi/GSK
Last month, French drugmaker Sanofi said that it expects to start clinical testing of its experimental coronavirus vaccine in September, several months earlier than planned. The...
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...
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...
