🇴🇲 Bioavailability & Bioequivalence (BA/BE) Studies Services for Oman
The primary regulatory authority in the Sultanate of Oman is the Directorate General of Pharmaceutical Affairs and Drug Control (DGPA&DC), which operates under the Ministry of Health (MOH).
Oman's pharmaceutical regulation is highly integrated with the Gulf Cooperation Council (GCC) unified drug registration procedures. This means generic drug approval requires stringent documentation aligned with GCC, ICH, and WHO standards. Crucially, Ministerial Decision No. 113/2020 confirms that generic products must prove quality, effectiveness, and suitability by passing necessary tests, including Bioavailability (BA) and Bioequivalence (BE), in accordance with global standards.
GCC/ICH-Compliant BA/BE & Comparative Dissolution Services — By BioEquiGlobal
BioEquiGlobal provides complete BA/BE study services designed to meet the rigorous requirements of the Oman DGPA&DC and the GCC Central Registration Process.
Our studies strictly follow ICH (E6, M10, M9), WHO TRS, Good Clinical Practice (GCP), and Good Laboratory Practice (GLP) standards, ensuring that the resulting Common Technical Document (CTD) dossier is acceptable for Marketing Authorization (MA) submission in Oman.
💊 Core Requirements for Generic Drug Registration in Oman (DGPA&DC)
1. Mandatory BA/BE Studies (In Vivo)
Regulatory Basis: Ministerial Decision No. 113/2020 explicitly mandates that the efficacy and suitability of generic medicines must be proven by necessary tests, including BA/BE, based on global standards and a recent study issued by an impartial scientific body (CRO) approved by the Drug Safety Center (DSC).
CRO Approval: The Oman MOH's Drug Safety Center has a formal procedure (Circular No. 69/2024) for the approval/re-approval of Contract Research Organizations (CROs), making it essential that the study vendor is pre-approved or recognized by the DSC.
Study Design: The standard single-dose, two-way crossover study under fasting conditions is typically required for immediate-release oral solid dosage forms.
Reference Product: The comparator must generally be the original brand name product (innovator), manufactured in the country of origin, or a product approved by a Stringent Regulatory Authority (SRA) or WHO PQ, aligning with GCC guidelines.
Ethics & Conduct: Studies must adhere strictly to GCP guidelines, with prior approval from an accredited Ethics Committee.
2. Analytical Method Development & Validation
Platforms: High-precision analytical methods, primarily LC-MS/MS
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, are necessary for accurate drug quantification.
Validation: Method validation must strictly conform to ICH M10 (Bioanalytical Method Validation) standards, which are the basis for GCC acceptance.
3. Pharmacokinetic (PK) Analysis and BE Criteria
Acceptance Range: The 90% Confidence Interval (CI) for the geometric mean ratio of $\text{AUC}$ and $\text{C}_{\text{max}}$ must be within the internationally accepted range of $80.00\%$ to $125.00\%$.
Washout Period: The washout period must be sufficient, typically at least five elimination half-lives of the drug/analyte.
4. Biowaiver Support and Comparative Dissolution Profiling (CDP)
Biowaiver Basis: Biowaiver justifications, based on the Biopharmaceutics Classification System (BCS), are accepted for eligible drugs (e.g., BCS Class I), provided they meet WHO/ICH M9 criteria and GCC requirements.
CDP Requirement: Comparative dissolution profiles ($f_2$ analysis) are required for all generic applications and for Biowaiver justifications, comparing the test product with the reference product.
📑 DGPA&DC-Ready Regulatory Documentation
Dossier Format: Submissions are generally required in the Common Technical Document (CTD) format, often submitted electronically (eCTD). The BA/BE data (CSR) must be placed in Module 5.
Language: Documentation, particularly the patient information leaflet (PIL) and labeling, must be provided in Arabic (and often bilingual Arabic-English).
Certificates: Mandatory documents include the Certificate of Pharmaceutical Product (CoPP) and a legalized Certificate of Free Sale from the country of origin.
Local Agent: A licensed local agent or authorized representative is required to submit and manage the registration process with the DGPA&DC.
🗺️ Our BA/BE Study Workflow for Oman/GCC
Feasibility & DGPA&DC Gap Assessment: Review of the RMP and Biowaiver eligibility against GCC/Oman requirements.
Protocol Development & Strategy: Drafting of the ICH/GCC-compliant study protocol and planning for EC and DSC (CRO) approval.
Analytical Method Development: Assay design ($\text{LC-MS/MS}$) and validation as per ICH M10 standards.
Clinical Study Execution: Conducted under strict GCP guidelines at an accredited, internationally recognized facility.
Bioanalysis & PK Evaluation: Bioanalytical phase, QC verification, PK evaluation, and statistical BE assessment.
Documentation & Submission: Finalization of the ICH E3-compliant CSR and preparation of a complete CTD submission package, with all required Arabic labeling/summaries, for the local agent to submit to the DGPA&DC.