Transfer of marketing authorisation: questions and answers – EMA
https://www.ema.europa.eu/en/human-regulatory/post-authorisation/transfer-marketing-authorisation-questions-answers
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.
New product information wording – Extracts from Pharmacovigilance Risk Assessment Committee (PRAC) recommendations on signals
https://www.ema.europa.eu/en/documents/prac-recommendation/new-product-information-wording-extracts-prac-recommendations-signals-adopted-6-9-july-2020-prac_en.pdf
List of European Union reference dates and frequency of submission of periodic safety update reports
https://www.ema.europa.eu/documents/other/list-european-union-reference-dates-frequency-submission-periodic-safety-update-reports_en.xls
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 July 2020
EMA’s human medicines committee (CHMP) recommended eleven medicines for approval at its July 2020 meeting.
ANSM pharmacovigilance risk-analysis questionnaire
The ANSM has sent to the Local QPPVs a pharmacovigilance risk-analysis questionnaire to prioritise PV inspections. Pharma companies should complete it by 30th Sep 2020.
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 July 2020
At its monthly meeting, EMA’s safety committee (PRAC) carried out its broad range of responsibilities, which cover all aspects of the risk management of the use of medicines.
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.
Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry
This guidance provides information on how the FDA defines the types of changes to approved risk evaluation and mitigation strategies (REMS), how application holders should submit changes to an approved REMS, and how the FDA will process submissions from application…