EDE updates pharmacovigilance guidelines for medical products; QPPV approval required
EDE highlighted requirements for approving the Qualified Person Responsible for Pharmacovigilance (QPPV) and their deputy at Marketing Authorisation Holder companies, as well as the responsibilities of relevant parties in establishing and maintaining pharmacovigilance systems, overseeing their quality and ensuring regulatory compliance.
The analysis — automated & source-checked
- Applies to
- Health & safety · UAE
- What to do
- Marketing Authorisation Holder companies must ensure they have an approved Qualified Person Responsible for Pharmacovigilance (QPPV) and deputy, and must align their pharmacovigilance systems and procedures with the updated EDE guideline during the transition period.
The Emirates Drug Establishment (EDE) has introduced updated guidelines on controls and conditions for good pharmacovigilance practices for medical products. The updated "Guideline on Controls and Conditions for Good Pharmacovigilance Practices for Medical Products" sets out new requirements for approving Qualified Persons Responsible for Pharmacovigilance (QPPV) and their deputies at Marketing Authorisation Holder companies. The guideline covers responsibilities for establishing and maintaining pharmacovigilance systems, risk management plans, pharmacovigilance system master files, and Periodic Safety Update Reports. It also specifies procedures and timelines for reporting adverse reactions in the UAE, including initial and final reports for serious cases and reports of non-serious cases. Additional requirements cover pharmacovigilance for patient support programmes, compassionate use, healthcare products, and post-authorisation safety studies. A transition period has been established for entities to align their systems and procedures with the updated guideline.
Source
Source: WAM — official 7 Oct 2026 Read the original ↗ More from WAM →
Quick answers
What do I need to do?
Marketing Authorisation Holder companies must ensure they have an approved Qualified Person Responsible for Pharmacovigilance (QPPV) and deputy, and must align their pharmacovigilance systems and procedures with the updated EDE guideline during the transition period.
Who issued this?
WAM (UAE).
When was it announced?
7 Oct 2026.
Where can I read the original?
Read the original at WAM: https://www.wam.ae/en/article/c2mg2bc-ede-customer-council-reviews-updated
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