Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 June 2021
https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-7-10-june-2021
Hong Kong – Guidance for Pharmaceutical Industry – Adverse Drug Reaction Reporting Requirements
https://www.drugoffice.gov.hk/eps/do/en/doc/Guidance_for_Pharmaceutical_Industry_en.pdf
PRAC recommendations on signals
https://www.ema.europa.eu/en/documents/prac-recommendation/prac-recommendations-signals-adopted-3-6-may-2021-prac-meeting_en.pdf
EMA – Medical Device Regulation comes into application
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
China_Announcement of the State Drug Administration on Issuing the _Pharmacological Vigilance Quality Management Standards_ (No. 65 of 2021)
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 May 2021
Eight new medicines recommended for approval.
Drug exposure during pregnancy and «Parent-Child reports» from Switzerland – instructions / recommendations of Swissmedic
https://www.swissmedic.ch/dam/swissmedic/de/dokumente/marktueberwachung/mu/drug_exposure_duringpregnancyandparent-childreportsfromswitzerla.pdf.download.pdf/drug_exposure_duringpregnancyandparent-childreportsfromswitzerla.pdf
Instruction document of the Spanish Agency for Medicines and Health Products for conducting clinical trials in Spain
https://www.aemps.gob.es/investigacionClinica/medicamentos/docs/Instrucciones-realizacion-ensayos-clinicos.pdf
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3-6 May 2021
https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-3-6-may-2021