You may be trying to access this site from a secured browser on the server. Please enable scripts and reload this page.
Sign In
Guidlines
Home
Home
Guidlines
Error loading navigation: TermStore not found
العربية
تحت رعاية صاحب المعالي وزير الصحة المهندس خالد بن عبد العزيز
Guidlines
Page Content
Human Drugs Submission
Renewal of Marketing Authorization
Variation Requirements
Stability
GCC Guidelines Bioequivalence
WHO Approved Guideline for Bioequivalence Centers
SPC
Storage & Transport of Time & Temp. Sensitive
Lab.
Manual of Drug Companies Violation
GMP Guidelines
GCC Guideline on Allergenic Products _v21
Guidelines on stability evaluation of vaccines
WHO guidelines on nonclinical evaluation of vaccines
Guidelines on clinical evaluation of
vaccines: regulatory expectations
WHO good manufacturing practices for biological products
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 :
Overarching biosimilar guidelines -1
:
Guideline on similar biological medicinal products
Guideline on similar biological medicinal products containing biotechnology-derived
proteins as active substance: non-clinical and clinical issues
Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues
Product-specific biosimilar guidelines -2
:
Guideline on non-clinical and clinical development of similar biological medicinal products containing low
Guideline on similar biological medicinal products containing interferon beta
Guideline on similar biological medicinal products containing monoclonal antibodies – non-clinical and clinical issues
Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant erythropoietins
Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human follicle stimulating hormone r-hfSH
Annex to Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance:non-clinical and clinical issues
GCC Guidelines for Production and Quality Control of Antisera _v21
GOOD CLINICAL PRACTICE E6
WHO Guidance on the establishment of new INN stems
Drug Barcoding Specifications
GCC Baseline eCTD Submission Requirement