1Department of Pharmaceutical Regulatory Affairs, K. B. Institute of Pharmaceutical Education and Research (KBIPER), A college of Kadi Sarva Vishwavidyalaya (KSV), Sector-23, Gandhinagar382023, Gujarat, India
2Makcur Laboratory Pvt. Ltd., Near Sola Bridge, SG Highway, Thaltej, Ahmedabad, Gujarat, India380013
*Corresponding author. E-mail address: niranjan.kanaki@kbiper.ac.in (N. Kanaki)
The regulatory approval of pharmaceutical products like Pre-filled Syringes (PFS) differs significantly among various international health authorities due to the format of the dossier, the time taken to evaluate the product, and the legal requirements that must be fulfilled. This paper seeks to compare the registration procedures of the National Drug Authority (NDA) of Uganda, which follows a five-module format of the Common Technical Document (CTD), and the Food and Drug Administration (FDA) of the Philippines, which follows the ASEAN format of the Asian Common Technical Dossier (CTD) comprising four parts. Unlike the NDA of Uganda, which regulates the Ugandan market, where 90% of the drugs used are imported, the FDA of the Philippines requires a Certificate of Product Registration (CPR) to market a product.
Regulatory approval for pre-filled syringes varies between Uganda and the Philippines in dossier format, timelines, and legal requirements. Uganda follows a five-module CTD, while the Philippines uses the ASEAN ACTD and requires a Certificate of Product Registration.
Pre-filled Syringe (PFS), Uganda, Philippines, NDA, FDA Philippines, CTD, ACTD
