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The Directorate General of Pharmaceutical Affairs & Drug Control (DGPA&DC) operates under the Ministry of Health (MoH), Sultanate of Oman, and is the national authority responsible for regulating medicinal products, pharmaceuticals, and related health products across their lifecycle.

DGPA&DC’s mandate is to ensure that medicines marketed in Oman are safe, effective, and of high quality, while aligning national regulations with GCC frameworks, ICH guidelines, and international Regulatory standards.

Regulatory Framework in Oman

Pharmaceutical regulation in Oman is governed by national health laws, ministerial decisions, and GCC-level harmonized guidelines. DGPA&DC plays a central role in:

  • Implementing GCC drug registration procedures
  • Adopting ICH-aligned quality, safety, and efficacy requirements
  • Ensuring compliance with pharmacovigilance and GMP standards
    This structured framework supports consistent Regulatory decision-making and facilitates regional market access.

Products Regulated by DGPA&DC

DGPA&DC regulates a wide range of products, including:

  • Prescription and over-the-counter (OTC) medicines
  • Generic, innovator, and branded pharmaceuticals
  • Biological and biosimilar products
  • Vaccines and blood-derived products
  • Herbal and traditional medicines
  • Controlled and narcotic substances (subject to additional approvals)

Core Responsibilities of DGPA&DC

DGPA&DC oversees the full medicinal product lifecycle, including:

  • Drug and medicinal product registration and marketing authorization
  • Scientific assessment of CTD/eCTD dossiers
  • Pricing evaluation and approval
  • GMP inspection, licensing, and manufacturing site registration
  • Import/export permits and batch release
  • Pharmacovigilance and post-marketing surveillance

Medicinal Product Registration in Oman

All locally manufactured or imported medicinal products must receive marketing authorization from DGPA&DC before commercialization. Key requirements include:

  • Appointment of a locally licensed Marketing Authorization Holder (MAH)
  • Submission of CTD or eCTD dossiers supported by CPP, GMP certificates, and stability data
  • Compliance with Oman-specific labeling and patient information leaflet requirements
  • Review timelines depend on product type, dossier completeness, and Regulatory pathway

Post-Approval Regulatory Obligations

Once approved, MAHs are responsible for ongoing compliance, including:

  • Variation and change management submissions
  • Registration renewals
  • Adverse event reporting and pharmacovigilance compliance
  • Participation in Regulatory inspections, audits, and quality reviews

Why DGPA&DC Matters for Global Pharma Companies

As part of the GCC Regulatory ecosystem, Oman represents a strategically important market for pharmaceutical expansion in the Middle East. Understanding and complying with DGPA&DC requirements is critical for successful market entry and ongoing product lifecycle management.

Key Functions and Advantages:

  1. Central Regulatory Authority
    Acts as the single national authority for medicinal product approvals in Oman.
  2. Market Access
    Enables entry into Oman and facilitates regional expansion across the GCC.
  3. Regulatory Alignment
    Ensures GCC- and ICH-aligned regulatory pathways, supporting global submissions.
  4. Product Lifecycle Oversight
    Governs drug registration, pricing, and ongoing lifecycle management.
  5. GMP and Manufacturing Compliance
    Mandates GMP adherence and manufacturing site approvals for local and international facilities.
  6. Pharmacovigilance and Safety
    Oversees post-marketing safety obligations and monitoring of adverse events.
  7. Predictable Market Access
    Provides a structured and regulated pathway for imported and locally manufactured medicines.

Planning to register medicinal products in Oman?

Connect with our Regulatory experts to navigate DGPA&DC requirements efficiently and compliantly.