It is important for the applicant to prepare and submit application with good quality dossier in order to obtain early approval in the registration process. The Good Submission Practice shall enhance efficiency and quality of product registration process and reduce unnecessary correspondences. This good practice will result in early access of medicinal product by patient.
NPRA seeks co-operation from the applicant to submit good quality data for product registration & failure to provide satisfactory documentation for registration within specified period may results in rejection.
Application for product registration shall be rejected if the applicant fails to submit required supplementary data/ information or documentation within six (6) months from the first correspondence date1.
a) Section 8.1.4 Conditions Applied On Product Registration; DRGD
b) Section 8.4.2 Correspondence; DRGD
c) Please also refer to NPRA circular Bil (08) dlm BPFK/PPP/01/03; Polisi Menolak Permohonan Pendaftaran Produk Dalam Penilaian Sekiranya Maklumbalas Tidak Dilengkapkan Oleh Pemohon Dalam Tempoh Enam (6) Bulan daripada Tarikh Permintaan(click here)