Snapshot

The Registration of Drug Products under Emergency Use for the Coronavirus Disease 2019 (COVID-19) (INITIAL-DEU) pathway has been developed by the Philippines Food and Drug Administration of Philippines.

This pathway can be used where These are the only considered Drug Products under Emergency Use (DEU) for the pandemic: 1. Tocilizumab 400 mg/ 20 mL Concentrate Solution for I.V. Infusion. 2. Lopinavir + Ritonavir 200 mg/ 50 mg Film-Coated Tablet. 3. Chloroquine Phosphate 250 mg Tablet / 500 mg Tablet. 4. Hydroxychloroquine Sulfate 200 mg Film-Coated Tablet. The list shall be updated following any change/s in the above-stated treatment guidelines. The DEU shall be locally manufactured or imported and distributed for the management of COVID-19 patients during the pandemic, following the PSMID Interim Guidelines..

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).