Hello there,
I work with Chinese clients expanding their products outside China but as far as I am aware even in Asia there is no mutual recognition for MA. They all have to run clinical trials in Japan, South Korea, etc and submit for MA.
The main challenge of such mutual recognition is that the data of the patient population has to be representative for the country where you are applying for MA. This is because there are differences in patients' response to treatment - for example, some drugs work better in Asian patients and not that well in European and USA patients and vis versa.
Have a good day.
Olga
------------------------------
Olga Peycheva
Regulatory and Study Start Up Specialist
Solutions OP Ltd
olga.peycheva@solutionsop.co.ukUnited Kingdom
------------------------------
Original Message:
Sent: 24-Apr-2023 17:29
From: Anonymous Member
Subject: Mutual Recognition Procedure for China Drug approvals?
This message was posted by a user wishing to remain anonymous
Dear RA Community:
Is anyone aware of any countries that recognize or have a mutual recognition procedure for China NMPA/CDE Drug approvals (perhaps Middle-east, Africa or APAC)?
Alternately, is there any awareness to which countries have an expedited regulatory procedure for sponsors that hold a China Drug approval in hand? I know for US, EMA, and Japan approvals such options may exist in other countries for expedited or mutually recognized approvals.
Any information on this topic or where one can go to find out would be very appreciated.
Best,
RA Professional