Updates on the Regulatory Framework of Drug Approvals and Guidance for Submission

<p class="ms-rteElement-P" style="text-align:justify">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.</p>
<p class="ms-rteElement-P" style="text-align:justify">The new updates of the Regulatory Framework of Drug Approvals are:H1</p>
<p class="ms-rteElement-P" style="text-align:justify">·  Addition of the registration rules<br />·  Unified the various marketing authorization application process of products licensing in one process<br />· Minor changes in the renewal procedure<br />· Update in the variation process to comply with the new variation guideline</p>
<p class="ms-rteElement-P" style="text-align:justify">Where the update on the Guidance for Submission are as follows:</p>
<p class="ms-rteElement-P" style="text-align:justify">· Only selected documents of module 1 will be requested as a hard copy<br />· Addition of a new page explaining the renewal process<br />· Addition of a new page explaining the variation process<br />· Minor changes in the requirements of GCC registered products<br />· In appendix C, the NeeS structure has been adjusted to be compatible with the eCTD, with a new figure</p>
<p class="ms-rteElement-P" style="text-align:justify">Both guidelines are published in the Drug Sector website in the guidelines section with the release notes.</p>