Hello Anon,
Consider looking through a pathway with WHO (World Health Organisation) for product introduction into countries where there is a need for medical supplies. Sometimes this still requires a "home country" approval, but there are some pathways there which could be tried if there is an unmet need or patient specific assistance. Individual countries may also have pathways for product approval/registration without home country approval, though you would probably need to work with a specific in-country expert/specialist.
------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Principal Strategy Consultant
NAMSA
------------------------------
Original Message:
Sent: 25-Mar-2024 12:01
From: Anonymous Member
Subject: South East Asia/ Eastern Asian possible regulatory pathways
This message was posted by a user wishing to remain anonymous
Hello All,
I have a unique regulatory situation that we are trying to navigate. We are a US company that is developing a diagnostic great product. The issue we are running into is the disease is only prominent in Southeast Asia and some Eastern Asian countries. We do not have any market history in any country at this point and do not have Country of Origin certificate. The Southeast Asian and Eastern Asian counties are our priority markets for this product. With most all of the countries requiring either Reference Markets or Country of origin to register a product are there any countries or markets in that area that have less stringent requirements or a way to undergo a more full registration evaluation without have refence market certificates/Country of Origin?
We are not looking for an easy way to register but rather just a possible regulatory pathway into to those markets without first having the above mentioned certificates for the specific product.
Any insight is greatly appreciated