Latest Announcement

17 June 2020

A temporary notice on mode of DMF submission by DMF Holders are as below:

NPRA understands the impact of COVID-19 pandemic on regulatory affairs, many countries are currently under lockdown/ restrictions that may affect deliveries of DMFs to NPRA. Therefore, NPRA is accepting DMFs submitted by API manufacturers via secured online data transfer during this difficult period. DMF holders may communicate the transfer matters with NPRA via email Alamat emel ini dilindungi dari Spambot. Anda perlu hidupkan JavaScript untuk melihatnya. (for new drug products) or Alamat emel ini dilindungi dari Spambot. Anda perlu hidupkan JavaScript untuk melihatnya. for (generic products). Information below shall be provided as reference:

a) Indication for submission: New Product Application/ Renewal/ Variation

b) Name of Product 

c) Name of Product Registration Holder (PRH)

d) Name of API 

e) Name of DMF Holder

f) Name and Address of API Manufacturer

g) DMF Version Number

Directives & Circulars Related to Regulatory Controls of Active Pharmaceutical Ingrediants