The new article outlines the key points to be addressed when initiating a clinical investigation, as well as upon its completion.
Table of content
The Egyptian Drug Authority (EDA) has published the guidelines for Good Regulatory Oversight of clinical trials. The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration by the parties responsible for clinical investigations in order to ensure the safety of study participants, as well as the accuracy and reliability of the results.
The authority also reserves the right to make changes to the guidelines and recommendations provided, should such changes be reasonably necessary to reflect corresponding amendments to the underlying regulations.
Clinical Medical Research Site Activation
According to the guidance, before activating a clinical medical research site, applicants are required to notify the Bio-Inn unit via email in advance. If a research site is activated without this prior notification, the Egyptian Drug Authority EDA may take regulatory action, including potentially suspending the study.
Periodic Progress Reports
Applicants must submit progress follow-up reports to both Bio-Inn (EDA) and the Supreme Council. These reports are required every four months from the EDA approval date, and the data must be cumulative.
Reports should be submitted using the “Follow-up template” (Template Forms 9.8). The deadline for submitting these reports is up to 15 days after the data lock point of the reporting interval.
Interim Clinical Study Report
If applicable, an interim clinical study report must be submitted as per the protocol, including interim results of the clinical medical research conducted in Egypt. This report should comply with the ICH E3 guidelines for the structure and content of clinical study reports.
Investigational Medicinal Product (IMP) Shipment Unlock
For imported investigational medicinal products (IMPs), after release from Egyptian customs, applicants must notify Bio-Inn before unlocking the sealed shipment. The IMP shipment must be unlocked in the presence of an EDA representative.
Failure to do so without EDA oversight could result in regulatory action. The notification should be sent via official email, and EDA will arrange the unlocking process.
Destruction of IMP
Applicants must inform Bio-Inn of their plans to destroy IMPs by submitting the necessary documentation, including:
- Detailed destruction procedures.
- Accreditation from the Ministry of Environment for the vendor or clinical trial site where destruction will occur.
- Contracts between the sponsor and site or vendor, stating where the destruction will take place.
- If the IMP will be returned to the sponsor, the sponsor must commit to handling the destruction and provide a bill of lading.
After the process, applicants must send evidence and a certificate of destruction to Bio-Inn. IMP destruction includes used, unused, expired, and empty packages.
For exporting unused IMPs, the sponsor must provide a bill of lading and commit to handling the destruction of the IMPs.
Destruction of Surplus Human Samples
Applicants should notify Bio-Inn about plans to destroy surplus human samples and submit the following:
- Detailed procedures for destruction.
- Accreditation certificate from the Ministry of Environment for the vendor or clinical trial site handling the destruction
- Contracts with the responsible entity, such as the laboratory or clinical trial site.
After the process, destruction evidence and a certificate of destruction must be sent to Bio-Inn.
If surplus human samples are exported, the sponsor or laboratory must commit to their destruction.
Safety Reporting
The document also highlights the key points related to safety reporting and the relevant obligations of the parties involved.
In particular, adverse events or reactions are categorized into grades based on severity:
- Grade 1 (Mild): Temporary, requiring no special treatment.
- Grade 2 (Moderate): May interfere with daily activities and require simple therapeutic measures.
- Grade 3 (Severe): Intolerable, requiring systemic therapy.
A serious adverse event is defined as any untoward medical occurrence that:
- Is life-threatening.
- Requires hospitalization or prolongs existing hospitalization.
- Results in disability or a congenital anomaly.
- Jeopardizes the patient or requires intervention to prevent the outcomes listed above.
The causality of adverse events is classified as:
- Certain: A clear relationship between the event and drug administration.
- Probable/Likely: The event likely results from drug administration.
- Possible: The event could be related to drug administration but might also have other causes.
- Unlikely: The event is probably unrelated to drug administration.
- Unassessable: Insufficient information to determine causality.
- Not Related: The event is definitely not related to drug administration.
The Principal Investigator (PI) or sponsor must report serious adverse events (SAEs) to Bio-Inn and the Supreme Council within the required timelines, using the CIOMS form in XML format. Life-threatening events must be reported within 24 hours, while non-life-threatening SAEs should be reported within 7 days.
Follow-up reports are submitted as additional information becomes available. Serious breaches of the protocol or GCP principles must be reported to Bio-Inn within 7 days of becoming aware of the breach.
These breaches, along with protocol deviations, must also be included in the progress and annual reports.
End of Clinical Medical Research
The authority explicitly states that the definition of the end of clinical medical research must be clearly outlined in the protocol. Any changes to this definition must be submitted as amendments.
Applicants must notify Bio-Inn when research sites close and submit a summary of the study outcome and all relevant data as a preliminary report within 60 days of data lock. The final Clinical Study Report (CSR) must be submitted within 12 months of study completion.
Post-Trial Benefits
The applicant must notify Bio-Inn when participants shift to post-trial benefits. The Principal Investigator must submit a declaration stating which participants require continued treatment with the investigational medicinal product (IMP), along with the quantities needed for the proposed duration.
Early Termination or Withdrawal of the Study
In case of early termination or suspension of the trial by the sponsor, the investigator must inform the trial subjects and ensure proper follow-up. A formal letter must be submitted to Bio-Inn within 15 days, outlining the reasons for termination.
If the sponsor withdraws a protocol or amendment, a formal letter of withdrawal must be submitted.
EDA Suspension or Termination of the Study
The EDA has the authority to suspend or terminate clinical medical research for reasons such as non-compliance with GCP, GMP, protocol deviations, or safety concerns. In such cases, the decision is communicated to the Supreme Council, and the applicant is notified via email.
Conclusion
In summary, these guidelines from the EDA ensure that clinical medical research conducted in Egypt adheres to GCP standards and that all aspects, from site activation to the end of the study, are properly regulated and reported. This comprehensive oversight protects the rights and safety of trial participants while ensuring that research data are reliable and credible.
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