Update on Guidance Notes for API Information for Product Registration - Version 5.0 (June 2020)

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Please be informed that there has been an update on the Guidance Notes for Active Pharmaceutical Ingredient (API) Information Required for Product Registration. The updated document is available for download:

 

  

The summary of changes on Guidance Notes for Active Pharmaceutical Ingredient (API) Information Required for Product Registration are outlined below:

 

Version

Description of Updates

Effective date

Version 5.0

Appendix 4- Addition of Magnesium Sulphate, Medium Chain Triglyceride, Potassium Dihydrogen Phosphate and Sodium Lactate as examples of Atypical API

 

Addition of Part F Product Registration Application Referencing to a Drug Master File (DMF) Previously Submitted to NPRA

June 2020

 

Further to the change, 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 This email address is being protected from spambots. You need JavaScript enabled to view it. (for new drug products) or This email address is being protected from spambots. You need JavaScript enabled to view it. 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

 

 

 

 

 

National Pharmaceutical Regulatory Agency (NPRA)
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  • Email: npra@npra.gov.my
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