Snapshot

The Monitored Emergency Use of Unregistered Investigational Interventional Products (MEURI) pathway has been developed by the of Uganda.

This pathway can be used where investigational therapeutics for individual patients outside of clinical trials.

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

Target time assessment is Given the current legal and regulatory framework, National Drug Authority may only authorize drug-related clinical trials. Based on the premises that the use of unregistered investigational products during public health emergencies is done outside the context of clinical trials, the Minister of Health will delegate the responsibility of the regulatory approval of the Investigational Medicinal Product to the National Drug Authority. Thereafter, in consultation with technical experts who will constitute a National Task Force, will consider and approve the deployment plan following NDA approval of the unregistered investigational products or repurposed registered products (off-label) for use in the outbreak. The review of protocols for therapeutic use of the investigational products will be done jointly by a taskforce constituting a representative(s) from various institutions and/or disciplines. National Drug Authority will give a letter of no objection on the use of the proposed unregistered intervention based on the outcome of the joint ethical and scientific review and internal review of all the information submitted. The National Drug Authority will authorize the importation of the unregistered investigational interventional products-including off-label products, in line with the provisions of the National Drug Policy and Authority (Importation and Exportation of Drugs) Regulations 2014 and the Guidelines for verification of applications for importation of drugs for emergency or extraordinary circumstances. National Drug Authority will follow up Adverse Drug Reactions (ADRs) in line with the National Drug Policy and Authority (Pharmacovigilance), Regulations 2014 and the National Drug Policy and Authority (Pharmacovigilance) (Amendment) Regulations 2021. National Drug Authority shall reserve the right to perform due diligence and grant or decline importation requests under section 8(4) in consideration of safety, efficacy and quality; and in consideration of new information about drug products that may arise from time to time..