With the announcement of the MMDA dated January 18, 2022, it was stated that the CTD Guide and Application Form were updated within the framework of the Regulation on the Licensing of Human Medicinal Products, which entered into force on December 11, 2021.
Some explanations regarding the applications were made in this direction,
together with the regulations on such issues as diversity applications, shortened application, hybrid application, fixed combination application.
You can access the announcement from the link below.
https://lnkd.in/gfCDjFkF