Based on the Drug Sector efforts at SFDA to update the guidelines continuously, updates were made on the Regulatory Framework of Drug Approvals and Guidance for Submission. A release note is provided to clarify the differences between the old and new versions.

The new updates of the Regulatory Framework of Drug Approvals are:H1

·  Addition of the registration rules
·  Unified the various marketing authorization application process of products licensing in one process
· Minor changes in the renewal procedure
· Update in the variation process to comply with the new variation guideline

Where the update on the Guidance for Submission are as follows:

· Only selected documents of module 1 will be requested as a hard copy
· Addition of a new page explaining the renewal process
· Addition of a new page explaining the variation process
· Minor changes in the requirements of GCC registered products
· In appendix C, the NeeS structure has been adjusted to be compatible with the eCTD, with a new figure

Both guidelines are published in the Drug Sector website in the guidelines section with the release notes.