All comments can be sent at [email protected]. Deadline of submission of comments shall be by 21 August 2020.
This Circular aims to:
- Provide guidelines to reflect the actual manufacturer of drug products;
- Provide guidelines for all renewal, compliance, MR to Initial Applications which were disapproved due to non-submission of the Foreign current Good Manufacturing (cGMP) Clearance due to the reflected manufacturer is a loan license manufacturer; and
- Provide guidelines to all pending and incoming registration of drug products having a foreign trader.