Good Regulatory Review Practices

Working Group Chair(s)
Melissa Torres
Food and Drug Administration (FDA)
United States of America
Lakshmidevi Balakrishnan
Health Sciences Authority (HSA)
Singapore
Membership
Regulators
Status
Current

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:

Marketing Review Report Work Instruction
Assessment and Decision Process for the Recognition of a Conformity Assessment Body Conducting Medical Device Regulatory Reviews
Competence and Training Requirements for Regulatory Authority Assessors of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews
Regulatory Authority Assessment Method for Recognition and Surveillance of Medical Device Conformity Assessment Bodies
Requirements for Regulatory Authority Recognition of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews
Principles of Labeling for Medical Devices and IVD Medical Devices
Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices
Competence, Training and Conduct Requirements for Regulatory Reviewers

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)

Member sites

Regional harmonization initiatives

APEC LSIF Regulatory Harmonization Steering Committee

Global Harmonization Working Party (GHWP)

Pan American Health Organization (PAHO)

Official observers

Argentina, National Administration of Drugs, Food and Medical Devices

World Health Organization (WHO)