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

Service Description

This service allows applicants to apply for the accreditation of clinical or bioequivalence study centers that are not yet approved by the GHC Central Registration.

Service Process

• Log in using UAE PASS to start the service
• Fill out the application form
• Attach the required documents
• Pay the fees
• Submit the application
• Issue the Certificate of Accreditation for Clinical Study Center or Bioequivalence

Conditions & Requirements

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

Required Documents

• The following documents are required, according to each stage in the service:
• Phase I (at the Center):
• 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 Contracts of Leasing of the Clinical Unit and of the Rendering of Services of Laboratory Analysis (if applicable).
• Training schedule for employees.
• Curriculum of the main researchers and the persons responsible for the clinical, analytical and statistical stages
• List of SOPs, and at least 5 SOP’s from each section mentioned in the application from should be provided Organizational chart of the center and the study flowchart
• 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 Analysis laboratory 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 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).
• 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).
• Statistical Phase:
• Standards Operating Procedures, contemplating of the following points:
• Data entry ((tabulation, verification of transcript data, software used).
• Data processing and statistical analysis (calculation of pharmacokinetic parameter, methods for outliers detection, analysis of variance and calculation of confidence interval, software used.)
• Proof of contract between the bio-equivalence center and the person in charge of statistics (in case of outsourcing).