Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 May 2020
EMA’s human medicines committee (CHMP) recommended eight medicines for approval at its May 2020 meeting.
COVID-19: ANSM wishes to suspend clinical trials evaluating hydroxychloroquine treatment in patients as a precaution – Information Point
The ANSM was informed of the position of the scientific committee of the international Solidarity clinical trial in collaboration with the WHO on the suspension of the inclusions of new patients who had to be treated with hydroxychloroquine
Amendment to Implementing Regulation 920/2013 on the designation of notified bodies
On 19 May 2020, the Commission published an amendment to Commission Implementing Regulation (EU) 920/2013.
Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic
This guidance provides recommendations to industry regarding postmarketing adverse event reporting for drugs, biologics, medical devices, combination products, and dietary supplements during a pandemic.
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 May 2020
PRAC concludes review of new information on the known risk of breast cancer with hormone replacement therapy.
List of medicines under additional monitoring
The list of medicines under additional monitoring includes medicines authorised in the European Union (EU) that are being monitored particularly closely by regulatory authorities.
Pharmacovigilance: change in procedure for requesting follow-up information for individual case safety reports
Swissmedic is changing its procedure for requesting follow-up information for individual case safety reports.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 28-30 April 2020
EMA’s human medicines committee (CHMP) recommended eight medicines for approval at its April 2020 meeting.
International regulators pledge collective support to combat COVID-19 pandemic
EMA has endorsed a joint COVID-19 statement published today by the International Coalition of Medicines Regulatory Authorities (ICMRA) committing to a strengthening of global collaboration in the fight against coronavirus disease.
Reporting suspected side effects of medicines in patients with COVID-19
EMA and the national competent authorities are reminding patients with confirmed or suspected coronavirus disease (COVID-19) to report suspected side effects that they experience with any of the medicines they are taking.