Medicinal Product 
End-to-end support from experienced Regulatory experts.

Medicinal Products Regulatory Support in Kuwait – Overview

Kuwait’s pharmaceutical sector is part of the fast-growing GCC market, governed by strict Regulatory controls aligned with GCC-DR, ICH, and WHO guidelines. The KDFCA ensures that all medicinal products meet the required standards of quality, safety, and efficacy before approval.

To obtain Marketing Authorization in Kuwait, companies must submit GCC-formatted CTD dossiers, present valid GMP certification, obtain pricing approval, and comply with Arabic labeling requirements.

We support pharmaceutical manufacturers and importers throughout the Regulatory pathway—ensuring complete dossier accuracy, alignment with MoH/KDFCA guidelines, and timely product approvals.

Medicinal Product Classification in Kuwait

Under Kuwait MoH and GCC-DR regulations, medicinal products fall under the following categories:

• Prescription Medicines (Rx): Require a physician’s prescription and KDFCA approval.
• OTC Medicines: Must demonstrate proven safety and follow simplified but strict approval norms.
• Biologicals & Biosimilars: Require complete analytical comparability, nonclinical and clinical evidence.
• Controlled Substances: Strictly governed under narcotics and psychotropic regulations; special licensing is mandatory.
• Herbal & Natural Products: Evaluated based on composition and therapeutic claims; may need full registration.

All medicinal products must be registered with the MoH/KDFCA prior to marketing or importation. Distribution of unregistered products is prohibited.

Medicinal Product Registration & Approval Process in Kuwait

Regulatory Authority: Kuwait Drug and Food Control Administration (KDFCA), Ministry of Health
Legislation: GCC-DR Guidelines, Kuwait MoH Resolutions, Pharmacovigilance Regulations

Key Steps

1. Licensing

• Foreign manufacturers must appoint a local Marketing Authorization Holder (MAH).
• All manufacturing sites must hold GMP certification acceptable to the GCC authorities.

2. Dossier Submission 

• Submitted in CTD format (Modules 1–5) compliant with GCC standards.
• Requires CPP, GMP, quality data, stability studies, product samples, and Arabic labeling content.

3. Scientific Evaluation 

• KDFCA performs a detailed assessment of safety, efficacy, and quality.
• GCC-level assessments may also apply depending on product category.

4. Pricing Approval 

• Pharmaceutical pricing is controlled under MoH pricing regulations.
• Pricing Committee approval is mandatory before commercialization.

5. Marketing Authorization Grant 

• MA is issued upon successful evaluation and is valid per Kuwait MoH regulations.

Post-Authorization Requirements 

• Arabic labeling compliance.
• Batch release and import permits for each shipment.
• Local pharmacovigilance function under a Qualified Person (QPPV).

Specific Requirements by Product Type 

• Generics: Bioequivalence study reports required; GCC guidelines apply.
• Biologics/Biosimilars: Must follow WHO/ICH/GCC comparability frameworks.
• Vaccines: Require additional testing and batch release oversight.
• OTC Products: Streamlined registration but strict safety, labeling, and advertising rules.

Post-Approval & Pharmacovigilance 

Approved medicinal products in Kuwait are subject to continuous MoH monitoring:

• Renewals: Periodic updates with recent safety and quality documentation.
• Variations: Any change in formulation, manufacturing, pack size, or labeling must be pre-approved.
• Pharmacovigilance Requirements:
  
  • Local QPPV mandatory
  • ADR reporting in compliance with Kuwait PV guidelines
• Market Surveillance: MoH inspections, recalls, sample testing, and safety alerts.

We offer complete lifecycle management to maintain compliance and ensure continuous market availability.