Issue of a Certificate of Accreditation for a Center of Clinical Studies or Bioequivalence

Service completion duration

  • 4 months

Service fees

  • Approval certificate of clinical studies or bioequ...

Service Rating

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About the Service

This service enables clients to apply for the accreditation of GCC-approved centers for clinical or bioequivalence studies.

Service Process

  • 1
    Login to the MoHAP website or smart app using the UAE PASS

    • 2
      The application must include the documents required in accordance with Section 09 of the bioavailability/bioequivalence documentation application form

      • 3
        The officer in charge will review the documents and application for initial approval

        • 4
          The technical committee/higher committee shall evaluate the application for conventional drug registration

          • 5
            The certificate will be issued

            Conditions & Requirements

            1. This application should be submitted by the pharmaceutical company or the local agent which contracted with BA/BE center along with letter of authorization.

            2. The service is not required for bioavailability/bioequivalence centers approved by GCC countries.

            Service completion duration

            4 months

            Service fees

            Approval certificate of clinical studies or bioequivalence center: 2,000 AED

            Service channels
            • MOHAP Website

            Payment channels
            • E- Payment

            Target audience
            • Medical warehouses

            • Local pharmaceutical manufacturers

            Department name

            Drug

            Sector name

            Health Regulation

            Main service

            Medical, Pharmaceutical and Drug Licencing and Registration

            Service Code

            110-04-022-000

            Service Classfication

            Transactional

            Service Type

            Government to Business

            Sub Service Type

            Variation

            Number of Transactions

            2

            Notes

            The valid electronic seal is accepted for documents of government entities and companies.

            Required Documents
            • The following documents are required, according to each stage in the service:

            • Phase I (at the Center):

              • Application form.

              • Latest inspection report issued by competent authority (if any).

              • Notarized Copy of the operating license issued by the competent authority in the country of origin.

              • Copy of the Contract(s) of Leasing of the Clinical Unit and of the Rendering of Services of Laboratory Analysis (if applicable).

              • Training schedule for employees.

              • Curricula of the main researchers and the persons responsible for the clinical, analytical and statistical stages.

              • List of SOP’s , and 5 SOP’s from the above mentioned should be provided.

              • Organizational chart of the center and the study plan.

              • Background of the Bio equivalence Center (Site, Master file), including total number of studies conducted and list of those submitted to other health authorities.

              • Notarized copy of accreditation certificates.

            • Clinical Phase:

              • Notarized copy of the operating license issued by the competent authority in the country of origin (in case of outsourcing).

              • Staff training schedule.

              • List of the equipment and instruments used.

              • The following SOPs: collecting samples , emergency care of subjects, hospitalization of subjects, cleaning and preparation of areas for hospitalization of subjects.

            • Clinical Laboratory Analysis Stage:

              • Notarized copy of the operating license issued by the competent authority in the country of origin (in case of outsourcing).

              • Staff training schedule.

              • List of the equipment and instruments used.

              • List of technicians in the area with the technical qualifications for each professional.

              • Models of the control file / control records used ( temperature of the refrigerators, freezes, room temperature, room humidity, calibration of pipettes, reagents and standards).

              • Bio-safety programs.

            • Analysis Phase:

              • Notarized copy of the operating license issued by the competent authority in the country of origin (in case of outsourcing).

              • Staff training schedule.

              • List of the equipment and instruments used.

              • List of area technicians with technical qualifications for each professional.

              • Models of the control file / control records used ( temperature of the refrigerators, freezes, room temperature, room humidity, calibration of pipettes, reagents and standards).

            • Statistics Stage:

              • Standards Operation Procedures, contemplating of the following points:

              • a. Data entry ((tabulation, verification of transcript data, software used).

              • b. Data processing and statistical analysis (methods of calculating pharmacokinetic parameter methods to identify factors to define the outliers, variance analysis, confidence interval calculation and program used).

              • Proof of contract between the bio-equivalence center and the person in charge of statistics (in case of outsourcing).

            Sustainable Goals
            Good Health And Well-Being

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