Hello Susan,
Considering South-East Asia, only option is ASEAN member states countries that have harmonized the regulatory requirements to some extent.
However, the ASEAN members states do have their own distinct/specific regulatory requirements.
The countries that you have mentioned are not part of ASEAN, but there is a possibility of acceptance of clinical data and it needs to be verified from each of the filing country's MOH.
More details on South East Asian region, can be found on RAPS website itself, under Regulatory Focus, posted on 29th January'2018 titled " The Drug Regulatory Landscape in the ASEAN Region".
Hope this helps.
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PURVI GORADIA
Manager Regulatory Affairs
Mumbai
India
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Original Message:
Sent: 01-May-2018 11:43
From: Anonymous Member
Subject: Southeast Asia
This message was posted by a user wishing to remain anonymous
Can anyone recommend where I can find current information on the regulatory requirements for South East Asia? Specifically, what countries accept whose data. For example, can I register in Taiwan or Macau with clinical data obtained in Hong Kong?
Thanks!
Susan