https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-regulatory-submissions-electronic-format-standardized-study-data
https://www.ema.europa.eu/en/news/highlights-management-board-june-2021-meeting
https://www.aemps.gob.es/investigacionClinica/medicamentos/docs/instrucciones-notificar-promotor-EPA-no-TAC2.pdf?x54046
https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-7-10-june-2021
https://www.drugoffice.gov.hk/eps/do/en/doc/Guidance_for_Pharmaceutical_Industry_en.pdf
https://www.ema.europa.eu/en/documents/prac-recommendation/prac-recommendations-signals-adopted-3-6-may-2021-prac-meeting_en.pdf
https://www.ema.europa.eu/en/news/medical-device-regulation-comes-application
China_Announcement of the State Drug Administration on Issuing the _Pharmacological Vigilance Quality Management Standards_ (No. 65 of 2021)
EMA – EudraVigilance – Manuel d’enregistrement
Huit nouveaux médicaments recommandés pour approbation.