Directives, Circulars & Announcements for Active Pharmaceutical Ingredient (API)

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Latest Announcement

17 June 2020

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

No Document Name Date
1 PEKELILING LANJUTAN TARIKH PELAKSANAAN PENGAWALAN BAHAN AKTIF FARMASEUTIKAL (API) BAGI PRODUK FARMASEUTIKAL
BERDAFTAR YANG MENGANDUNGI RACUN BERJADUAL
27 Jun 2014
2 DIREKTIF PERLUASAN SKOP PELAKSANAAN KAWALAN REGULATORI KE ATAS BAHAN AKTIF FARMASEUTIKAL BAGI PRODUK
GENERIK YANG MENGANDUNGI RACUN BERJADUAL (FASA II)
16 Jan 2014
3 DIREKTIF PELAKSANAAN KAWALAN REGULATORI BAHAN AKTIF FARMASEUTIKAL DI MALAYSIA 17 Mar 2011

 

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National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

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The Government of Malaysia and the National Pharmaceutical Regulatory Agency are not responsible for any loss or damage caused by the usage of any information obtained from this website.

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  • Last Modified: Jumaat 27 November 2020, 10:09:22.
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