The framework changes the procedure for submitting periodic benefit-risk assessment reports and the analysis by the Agency’s sector dealing with pharmacovigilance. The frequency of presentation of reports, for example, will be carried out by a list published here, on the…
https://www.ema.europa.eu/en/documents/other/new-product-information-wording-extracts-prac-recommendations-signals-adopted-11-14-may-2020-prac_en.pdf
https://www.ema.europa.eu/en/documents/other/new-product-information-wording-extracts-prac-recommendations-signals-adopted-11-14-may-2020-prac_en.pdf
https://mhrainspectorate.blog.gov.uk/2020/08/03/gcp-serious-breaches-update/
https://www.ema.europa.eu/en/human-regulatory/post-authorisation/transfer-marketing-authorisation-questions-answers
The list of medicines under additional monitoring includes medicines authorised in the European Union (EU) that are being monitored particularly closely by regulatory authorities.
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
https://www.ema.europa.eu/documents/other/list-european-union-reference-dates-frequency-submission-periodic-safety-update-reports_en.xls
EMA’s human medicines committee (CHMP) recommended eleven medicines for approval at its July 2020 meeting.
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.