December 3, 2020
API Guidance Notes – Decode NPRA Malaysia Guidance

The NPRA Malaysia has updated, “Guidance Notes for Active Pharmaceutical Ingredient (API) Information Required for Product Registration” - Version 5.0 (June 2020). The guidance helps API manufacturers to expedite the registration process. Further to this update, a temporary notice on mode of DMF submission has also been provided as below.

Many countries are currently under lockdown due to the ongoing COVID-19 pandemic which in-turn has affected the deliveries of DMFs with the Regulatory Authorities. Addressing this, NPRA Malaysia has now started to accept DMF applications by API manufacturers via secured online data transfer. DMF holders may now communicate directly with NPRA via email, apiscreeningsub@npra.gov.my for new drug products or apiscreening@npra.gov.my for generic products providing the following information:

  1. Indication for submission: New Product Application/ Renewal/ Variation
  2. Name of Product
  3. Name of Product Registration Holder (PRH)
  4. Name of API 
  5. Name of DMF Holder
  6. Name and Address of API Manufacturer
  7. DMF Version Number

Are you holding DMFs to be submitted for the NPRA? Are you a manufacturer of APIs and aiming for their successful registration and compliant Malaysian market-entry? As a proven local Regulatory expertise, Freyr can assist you decode the guidance comprehensively. Reach out to us at sales@freyrsolutions.com