Register healthcare products centrally in the GCC by SFDA

Register healthcare products centrally in the GCC by SFDA udemy course

Central Registration with GHC

Central registration is the most updated ever pharma industry interesting topic. The topic has been always on the table for discussion, many times ago till it was enforced finally in 2021.

The central registration through the Gulf Health Council "GHC" for pharmaceutical products so far, and very soon will be applicable also to medical devices.

What will you learn?

• Introduction

• Central Registration Process

• Regulatory Aspects of the GCC Countries

• Module 1 in detail

• Module 2 in detail

• module 3 in details

• Module 4 and 5

• Module 3 insights

• Site Submission

• Central Renewal of Marketing Authorization

• Central Variation

• Central Variation List

• Central SMPC/PIL

• Stability testing of central registration

• Storage transportation f central registration

As a regulatory affairs professional you must keep up to date with the changing regulations, especially in the META region

The central registration option allows you to make only one single submission, one single dossier for your product, that will be approved in all other GCC countries, so going central, means going to the whole GCC region by only one submission.

Still, you have to submit it individually to each country, but it is just admin work, and the dossier has already been revised and proven by the Gulf Health Council, so it takes 2 months instead of 1 year, does that sound great? for sure

However, soon you will not have to submit individually anymore after the central registration submission

Central registration is mandatory for the pharma industry business as it is not allowed to apply for the tenders in the GCC region unless you have central registration, those tenders cannot be missed for any company to achieve the potential ROI.

In this course, we will cover everything related to the topic of the central registration

Staring by Gulf Central Committee For Drug Registration, Human Drugs Centralized Registration Process, Module 3 insights, Company (Site/MAH) Centralized Registration, GCC Guidelines for Renewal of Marketing Authorizations, GCC Guidelines for Variation Requirements, GCC Guidelines for Variation Requirements, GCC Guidelines for Presenting the SPC, PIL and Labeling Information, GCC Guidelines for Stability Testing of Active Pharmaceutical Ingredients ( API) and Finished Products ( FPS), GCC Guidelines for the Storage and Transport of Time and Temperature-Sensitive Pharmaceutical Products, and finally the central site audit.

Let us master central registration together.