The registration process at FDA Philippines is quite systematic and mostly electronic. eSubmissions is the only acceptable mode, unless the FDA is specifically asking to submit offline copies. Registration is mandatory for all medicinal products, although in rare cases Emergency Authorization for limited period is granted.

The process requires for first requesting for an appointment with FDA for submission of Dossier for PreAssessment. At this stage, the FDA reviews the Dossier for Adequacy and once found complying, fees are deposited and Dossier accepted for full qualitative review.

The process can only be done through local Philippines companies which have an LTO.  Samples are not required for purpose of analysis, however, the FDA may ask us to submit representative samples.

The complete process usually takes between 24 to 36 months. 

Depending on requirements, we can file applications on our LTO or yours !!

Site Audits are not mandatory, but a GMP Clearance from FDA is required, ideally, prior to submission of the first dossier. 

The FDA follows ACTD Guidelines, with various changes according to the Drug Category. The classification by FDA can be as a Generic Drug, Monitored Release, OTC, Biosimilars, etc. The checklist varies for all categories. As a general reference, we have enclosed here a checklist of Generic Drugs, fresh filing. FDA accepts only stability studies conducted under Zone IV B conditions. 

Need our assistance ! We, at Genedrift can handle this for you.

Click here to download the checklist.