Reminder: Implementation of Regulatory Control of Active Pharmaceutical Ingredients (API) For Registered Products with Registration Expiration Starting 1 January 2020


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With respect to the above and Directive BPFK/PPP/01/03/J3(11) is referred.


Regulatory control of API for registered products* with registration expiration starting 1 January 2020 has been enforced. In order to fulfill the criteria for registration renewal, product registration holders (PRH) must provide required API information via “Section S Revision” at least 12-15 months before the registration expiration date.


* Products containing scheduled poisons in Category of New Drug Product (NDP) or Prescription (Full)



Guidelines and procedures of regulatory control on API for registered products are available on NPRA’s website: Guidance Notes Required Documents for API Information and Carta Aliran untuk Kawalan Regulatori API ke atas Produk Berdaftar.



Application for “Section S Revision” shall be submitted online via Form RegA1 (Application Form for Section S Revision for Product Registered Before the Implementation of Directive on Regulatory Control of API), which is also available on NPRA’s website.



Applications will be screened and “Product editing” will be enabled for products that are eligible to conduct “Section S Revision”. This module will be enabled based on a schedule with a frequency of 2 times per month. The schedule referred is available at Jadual Pembukaan "Section S Revision" QUEST 3+. Applicants are reminded that each product is only allowed ONCE** for "Section S Revision".


** Please ensure that the requested product is not in pending status for variation, COH, COS, additional indication, payment etc.



For further information please refer to Frequently Asked Question – Section B: API in Registered Products



Your attention on this matter is appreciated.



Thank You.



API Section,


Centre of Product Registration, NPRA.