The approval process for unregistered medicinal products under Early Access Program (EAP) in Cambodia is as follows:
The applicant must submit a request for EAP to the Drug Regulatory Authority of Cambodia (RAC).
The RAC will review the request and determine if the product meets the criteria for EAP.
If the product meets the criteria, the RAC will issue a letter of no objection (LONO).
The applicant must then submit a comprehensive patient information sheet (PIS) and a risk management plan (RMP) to the RAC.
The RAC will review the PIS and RMP and determine if they are adequate.
If the PIS and RMP are adequate, the RAC will issue an EAP approval.
The EAP approval will allow the applicant to import and distribute the unregistered medicinal product in Cambodia. The product will be available to patients who have a serious or life-threatening condition and who have exhausted all other treatment options.
The following are the criteria for EAP in Cambodia:
The product must be a new medicinal product that is not yet registered in Cambodia.
The product must be intended to treat a serious or life-threatening condition.
There must be no other available treatment options for the condition.
The product must have a favorable risk-benefit profile.
The applicant must provide adequate information about the product, including the PIS and RMP.
The EAP approval process in Cambodia is relatively straightforward. The RAC will review the request and supporting documentation within 30 days. If the product meets the criteria, the RAC will issue an EAP approval.
The EAP approval is valid for one year. The applicant can apply for a renewal of the approval if the product is still being used to treat patients in Cambodia.
For more information on the EAP approval process in Cambodia, please visit the website of the RAC.
Here are some of the key documents that must be submitted as part of the EAP approval process:
Request for EAP: This document must include information about the product, the patient population, and the clinical evidence supporting the use of the product.
Letter of no objection (LONO): This document is issued by the manufacturer of the product and it confirms that the product meets the quality standards of the RAC.
PIS: This document provides information about the product, including its indications, contraindications, side effects, and dosage.
RMP: This document describes the risk management plan for the product, including how the risks of the product will be minimized.