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العربية تحت رعاية صاحب المعالي وزير الصحة المهندس خالد بن عبد العزيز

Guidlines

Human Drugs Submission

Renewal of Marketing Authorization

Variation Requirements

GCC Guidelines Bioequivalence

WHO Approved Guideline for Bioequivalence Centers

Storage & Transport of Time & Temp. Sensitive

Manual of Drug Companies Violation

GMP INSPECTION REPORT

GCC Guideline on Allergenic Products _v21

GCC Guidelines for Production and Quality Control of Vaccines_v21

GCC Guidelines for Production and Quality Control of Blood Products_v1101

GCC Guidelines on biosimilars_v11

GCC Guidelines for Production and Quality Control of Antisera _v21

ICH Guidelines Clinical Practice E6 (R1)

WHO Guidance on the establishment of new INN stems

How to register for the GHC Web Clinte - Guidance for applicants

Web clinte User Guide - Guidance for applicants

GHC Electronic Submission Portal - Naming Convention Files

Drug Barcoding Specifications

GCC Baseline eCTD Submission Requirement