https://baipharm.chemlinked.com/news/china-nmpa-announces-key-points-for-pharmacovigilance-inspections

https://www.ich.org/page/e2br3-individual-case-safety-report-icsr-specification-and-related-files

https://ansm.sante.fr/actualites/entree-en-application-du-nouveau-reglement-europeen-relatif-aux-essais-cliniques-des-medicaments

https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/reporting-safety-information-clinical-trials

https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/medicines-under-additional-monitoring/list-medicines-under-additional-monitoring

https://www.ema.europa.eu/en/documents/minutes/minutes-prac-meeting-6-9-april-2021_en.pdf