Update of Guidance Notes for API Information for Product Registration - Version 4.0 (December 2019)

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This is to inform that there has been an update on the Guidance Notes for Active Pharmaceutical Ingredient (API) Information Required for Product Registration.

 

 

Further to the change, new reference documents are also available for:

1. Template Cover Letter for DMF Submission  

2. Schedule for Opening of Section S Revision for 2020  

 

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

 

LIST OF UPDATES FOR GUIDANCE NOTES FOR ACTIVE PHARMACEUTICAL INGREDIENT (API) INFORMATION (PART II S)

FOR QUEST 3+ PRODUCT REGISTRATION APPLICATION, VERSION 4.0, DEC 2019

No.

Version

Description of Updates

Effective date

1

Version 1.0

Initial Publication

April 2018

2

Version 2.0

Addition of Part C - Regulatory Control of API for Product Registered Before the Implementation of Directive on Regulatory Control of API in Malaysia

July 2018

3

Version 3.0

 

Change of Part D to Part E for Good Manufacturing Practice Compliance Evidence for Manufacturers Involved.

Addition of Part D - Regulatory Control of Atypical APIs

Addition of Appendix 4 - List of Atypical Active Pharmaceutical Ingredient (API)

Addition of Appendix 5 - Summary of Required Documents for Atypical Active Pharmaceutical Ingredient (AAPI) Information

October 2019

4

Version 4.0

Change of name from “Center of Product Registration” to “Centre of Product Evaluation and Cosmetic”

Submission to API Section changed to submission to Head of New Drug Product Section* / Head of Generic Medicines Section* (*refer to product category) 

Template of Cover Letter for DMF submission is available on NPRA website

Upon payment, submission of CD copy to “Center of Product Registration” or “Center of Quality Control” are no longer required.

December 2019

 

 

 

 

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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