The Egyptian Drug Authority (EDA) announces the opening of a public consultation to gather feedback from strategic partners and stakeholders in the pharmaceutical manufacturing sector regarding the draft "Regulatory Guidelines on the Rules and Procedures for the Accreditation and Appointment of the Qualified Person (QP) in the Pharmaceutical Industry."

The release of these guidelines comes as part of the Authority's efforts to develop and update relevant regulatory frameworks in alignment with international best practices and applicable regulatory standards. This aims to establish a clear framework governing the requirements for accrediting and appointing a Qualified Person, as well as defining their duties and responsibilities to support existing quality management systems within pharmaceutical manufacturing facilities.

Furthermore, the guidelines aim to enhance auditing and final verification mechanisms to ensure batch compliance with approved requirements. This will contribute to supporting the quality, safety, and standards of pharmaceutical products, while boosting the efficiency of the pharmaceutical manufacturing oversight system.

The Authority invites all concerned entities, stakeholders, experts, and specialists in the pharmaceutical manufacturing sector to review the draft guidelines and submit their feedback and suggestions, helping to reach a comprehensive, clear, and applicable regulatory framework.

Mechanism for Submitting Feedback:

When sending feedback and proposals, please specify the following:

● Line or section number under comment.

● Proposed text or amendment.

● Scientific or regulatory justification for the proposal.

Feedback and suggestions should be sent via email to: Lab.chair.adv.tech@edaegypt.gov

The deadline for submission is September 1, 2026.

To view the draft Regulatory Guidelines for the Qualified Person (QP), please click on the link.