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Biologics Compliance Guide for Dubai

This is a compliance guide for clinics that want to operate in Dubai.

Key Pieces of Legislation:

1. Federal Decree Law No. (49) of 2023

This law regulates the use of the human genome, which can be relevant to the use of exosomes in treatments


2. Federal Law No. (7) of 2019

This law concerns medical assistance in reproduction and includes provisions related to the use of biological materials, which may encompass exosomes.


3. Federal Decree Law No. (49) of 2023

This law regulates the use of the human genome, which can be relevant to the use of exosomes in treatments.


4. Ministerial Decree No. (306) of 2023

This decree concerns the list of semi-controlled medical materials and products, which may include exosomes.


5. DHA Standards and Guidelines

The DHA provides specific standards and guidelines for the use of stem cells and regenerative medicine, which can be applied to exosome therapies.


6. Compliance Checklist

Verify Licensing and Certification: 

  • Ensure that the clinic and medical professionals are properly licensed and certified to perform stem cell treatments.

Adhere to DHA Regulations: 

  • Follow the Dubai Health Authority (DHA) regulations for stem cell therapies, including obtaining necessary approvals for investigational new drugs (IND) if applicable.

Informed Consent: 

  • Obtain informed consent from patients, clearly explaining the potential risks, benefits, and alternatives to the treatment.

Compliance with UAE Laws:

  • Ensure compliance with UAE-specific regulations and guidelines for stem cell treatments"


6. Who can administer
  • Doctors (General Practitioners and Specialists): Physicians with appropriate licenses from the Dubai Health Authority (DHA).
  • Nurses: Registered nurses who are certified and licensed to administer biologic products under the supervision of a licensed physician.
  • Pharmacists: Licensed pharmacists who can dispense biologic products in accordance with DHA regulations.
  • Medical Assistants: Certified medical assistants who work under the supervision of licensed healthcare professionals.

Source Info

https://services.dha.gov.ae/sheryan/wps/portal/home/circular-details?circularRefNo=CIR-2020-00000313&isPublicCircular=1&fromHome=true

https://uaelegislation.gov.ae/en/legislations/1438/download

https://uaelegislation.gov.ae/en/legislations/2195/download

https://dhcc.ae/regulations/guidelines-and-standards