EMA’s human medicines committee (CHMP) recommended eight medicines for approval at its May 2020 meeting.
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
On 19 May 2020, the Commission published an amendment to Commission Implementing Regulation (EU) 920/2013.
This guidance provides recommendations to industry regarding postmarketing adverse event reporting for drugs, biologics, medical devices, combination products, and dietary supplements during a pandemic.
PRAC concludes review of new information on the known risk of breast cancer with hormone replacement therapy.
The list of medicines under additional monitoring includes medicines authorised in the European Union (EU) that are being monitored particularly closely by regulatory authorities.
Swissmedic is changing its procedure for requesting follow-up information for individual case safety reports.
EMA’s human medicines committee (CHMP) recommended eight medicines for approval at its April 2020 meeting.
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.
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.