Good Regulatory Review Practices

Working Group Chair(s)
Dr Kenneth Cavanaugh
Food and Drug Administration (US FDA)
United States of America
Lai Peng Low
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

Boussuge Salvador María Candelaria
National Administration of Drugs, Food and Medical Devices (ANMAT)
Cecilia Carrón
National Administration of Drugs, Food and Medical Devices (ANMAT)
Gabriel Schugurensky
National Administration of Drugs, Food and Medical Devices (ANMAT)

Jie Zhou
Therapeutic Goods Administration (TGA)
Sushil Khatri
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)

Laith Al Helo
Jordan Food And Drug Administration (JFDA)
Neda Al Shaer
Jordan Food And Drug Administration (JFDA)

Vladimir Antonov
Federal Service for Surveillance in Healthcare (Roszdravnadzor)

Lai Peng Low
Health Sciences Authority (HSA)

Soonyeong Park
Ministry of Food and Drug Safety (MFDS)

Ms Michal Neukamp
Swissmedic
Simone Frank
Swissmedic

Madhavan Srinivasan
Medicines and Healthcare products Regulatory Agency (MHRA)
Rob Higgins
Medicines and Healthcare products Regulatory Agency (MHRA)

Dr Kenneth Cavanaugh
Food and Drug Administration (US FDA)
Melissa Torres
Food and Drug Administration (US 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)

African Medical Devices Forum (AMDF)

Official observers

Argentina, National Administration of Drugs, Food and Medical Devices

The World Health Organization (WHO)

Saudi Arabia, Saudi Food and Drug Authority

Switzerland, Swissmedic

Affiliate members

Botswana - Botswana Medicines Regulatory Authority (BoMRA)

Chile - Public Health Institute of Chile (ISP)

Chinese Taipei Taiwan Food and Drug Administration (TFDA)

Costa Rica - Ministry of Health

Cuba - Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos (CECMED)

Dominican Republic - General Directorate of Medicines, Food and Health Products (DIGEMAPS)

Egypt - Egyptian Drug Authority  (EDA)

El Salvador - Sanitary Regulation Superintendency (SRS)

Ethiopia - Ethiopian Food and Drug Authority (EFDA)

India - Central Drugs Standard Control Organization (CDSCO)

Israel - The Medical Technology, Health Information, Innovation and Research Directorate (MTIIR)

Affiliates

 

Jordan - Jordan Food and Drug Administration (JFDA)

Kenya - Pharmacy and Poisons Board (PPB)

Mexico - Federal Commission for Protection from Sanitary Risks (COFEPRIS)

Montenegro - Institute for Medicine and Medical Devices of Montenegro (CINMED)

Nigeria - National Agency for Food and Drug Administration Control (NAFDAC)

Oman - Drug Safety Center, Medical Device Control Department (DSC)

Paraguay - National Health Surveillance (DINAVISA)

Peru - General Directorate of Medicines, Supplies and Drugs (DIGEMID)

South Africa - South African Health Products Regulatory Authority (SAHPRA)

Tanzania - Tanzania Medicines and Medical Devices Authority (TMDA)

Zimbabwe - Medicines Control Authority (MCAZ)