Good Regulatory Review Practices
The charter of the Good Regulator Review Practices (GRRP) working group is to develop guidance that establishes good regulatory review practices for regulatory authorities and/or their conformity assessment bodies.
The Review Practices (GRRP) working group aims to improve the effectiveness and efficiency of pre-market review. The GRRP working group has produced documents to support pre-market review including:
Technical/Informational document
Participants
Fiona McCormack
Therapeutic Goods Administration (TGA)
Augusto Bencke Geyer
Brazilian Health Regulatory Agency (ANVISA)
Catherine Milley
Health Canada
Maria Carballo
Health Canada
Shiqing Zhang
National Medical Products Administration (NMPA)
Yuxi Yang
Center for Medical Device Evaluation (CMDE)
Aleksandra Rodatus-Gil
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Poland
Mairead Finucane
European Commission
Maria-Chiara Orlandi
European Commission
Mario Gabrielli-Cossellu
European Commission
Patrick Murphy
Health Products Regulatory Authority (HPRA), Ireland
Aoyagi Yumiko
Ministry of Health, Labour and Welfare (MHLW)
Dr Koichi Aizawa
Pharmaceuticals and Medical Devices Agency (PMDA)
Dr Madoka Murakami
Pharmaceuticals and Medical Devices Agency (PMDA)
Takehiro Ichikawa
Pharmaceuticals and Medical Devices Agency (PMDA)
Vladimir Antonov
Federal Service for Surveillance in Healthcare (Roszdravnadzor)
Lakshmidevi Balakrishnan
Health Sciences Authority (HSA)
Soonyeong Park
Ministry of Food and Drug Safety (MFDS)
Ms Michal Neukamp
Swissmedic
Dr Kenneth Cavanaugh
Food and Drug Administration (FDA)
Melissa Torres
Food and Drug Administration (FDA)
Deirdre Healy
World Health Organization (WHO)
Irena Prat
World Health Organization (WHO)
Mark Lanigan
World Health Organization (WHO)