As many lower and middle-income countries continue to scramble for COVID-19 vaccine doses, which are largely being manufactured in Europe and the U.S., their own regulatory rules may be getting in the way in some instances.
LONDON – The U.K. Medicines and Healthcare products Agency (MHRA) has embarked on wide-ranging reforms that are designed to make the most of post-Brexit regulatory flexibility while capitalizing on the ‘spirit of the pandemic,’ which has seen it rise to the occasion in supporting rapid set up of large-scale randomized clinical trials and approvals of COVID-19 vaccines.
LONDON – Moves to expand the legal remit of the European Medicines Agency (EMA) and give it more powers to deal with the COVID-19 pandemic and future health emergencies are moving to fruition, after the European Parliament and national health ministers in the European Council separately voted through the proposal.
LONDON – There has been a lukewarm reception from the industry to the latest developments in the plan to establish a European health technology assessment (HTA) agency, with concerns from pharma that member states will be able to pick and choose whether to apply joint evaluations in national reimbursement and access negotiations.
DUBLIN – In a busy week at the EMA, its Committee on Human Medicinal Products (CHMP) nodded through eight marketing applications at its June meeting. The haul included a chimeric antigen receptor T-cell (CAR T) therapy, three antibodies, including a biosimilar, and two new small-molecule drugs, as well as two generics.
The U.S. isn’t the only country tossing COVID-19 vaccines due to potential cross-contamination of the drug substances manufactured at an Emergent Biosolutions Inc. plant.
For almost two months, Brazil’s health care surveillance agency Anvisa, the European Medicines Agency, and the Directorate-General for Health and Food Safety have been sharing regulatory and confidential information as part of an effort to improve the safety and efficacy of drugs and medical devices.
For almost two months, Brazil’s health care surveillance agency Anvisa, the European Medicines Agency (EMA), and the Directorate-General for Health and Food Safety have been sharing regulatory and confidential information as part of an effort to improve the safety and efficacy of drugs and medical devices.
DUBLIN – The European Medicines Agency (EMA) has reiterated its support for Astrazeneca plc’s Vaxzervia COVID-19 vaccine, following an interim analysis of a data review, which the agency’s Committee on Human Medicinal Products (CHMP) has conducted over the past two weeks.
LONDON – The EMA’s safety committee has concluded that unusual blood clots with low blood platelets are a rare side effect of Johnson & Johnson Inc.’s COVID-19 vaccine and that a warning should be added to the label. The decision is based on all available evidence, which currently consists of eight reports from the U.S. of serious cases of thrombosis, one of which was fatal. All cases were in people under 60 years of age, and within three weeks after vaccination, the majority in women. One case occurred during the clinical trials.
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