Consultation closed

RPS Table of Contents Pilot

Start date
Closing date
Working group
Regulated Product Submission

The Regulated Product Submission (RPS) proposal was endorsed as a New Work Item (NWI) by IMDRF at its inaugural meeting in Singapore (March 2012). The Table of Contents (ToC) Working Group has previously conducted pilots for both Non-IVD and IVD ToC structures, using historical submissions. This pilot is being conducted with the following general objectives:

  • To evaluate the adaptability of the ToC structure from an industry perspective when applying to more than one jurisdiction (simultaneously or sequentially) using real regulatory submissions.

The pilot was initiated on 1 October 2015, and is projected to run for a minimum of twelve (12) months or until all objectives are met. Upon conclusion, all findings will be posted on the IMDRF website.

Further information about this pilot is available here.

Please use the comments template to provide comments on the pilot.

Comments - RPS ToC Pilot

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

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)

Malaysia - Medical Device Authority (MDA)

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)

Uzbekistan - The Center for Pharmaceutical Products Safety 

Zanzibar - Zanzibar Food and Drug Agency (ZFDA)

Zimbabwe - Medicines Control Authority (MCAZ)