DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)UPDATESNO.REVISIONSECTION/APPENDIXDETAILSREFERENCEReplacement of this statement at 11. Guideline for theSubmission of Product Samples for Laboratory Testing:3. May 2013Section C:Quality Control“The sample shall be submitted to the Centre for QualityControl within 14 days after the payment has been confirmed.Application for product registration shall be rejected by theAuthority if the sample is not submitted within 30 days from thedate of confirmed payment.” (deleted)With the following:Pharmacy RegulatoryPolicy MeetingNo. 1/2013“The applicant is given a period of 14 days from the date ofconfirmed payment to send samples for laboratory testing. Ifthe samples are not submitted within the specified time frame,the product registration application shall be tabled to theAuthority for rejection.” (replacement)4. May 2013Section E:Post-RegistrationProcessi) Addition of the following paragraph and link at 14.Maintenance of Registration:“For pharmaceutical products which were submitted forregistration before 2009, applicants shall ensure that stabilitystudy for the products at zone IV B has been conducted andgranted variation approval before submission of registrationrenewal application. Please refer circular(1)dlm.BPFK/PPP/01/03Jld.3, 5 April 2013 for moreinformation.”Circular(1)dlm.BPFK/PPP/01/03Jld. 3, 5 April 2013:Keperluan Data KajianStabiliti Dalam Zon IV BBagi Produk FarmaseutikalBerdaftarNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 494
Drug Registration Guidance Document (DRGD)UPDATESNO.REVISIONSECTION/APPENDIXDETAILSREFERENCEii) Amendment of the following paragraph and addition oflink at 17.2 POST-MARKET SURVEILLANCEa) It is the prime responsibility of the holder to ensure productsmarketed are in accordance to the standards andrequirements of the Authority. Samples of productsregistered by the Authority may be taken and tested forcompliance with official or pharmacopoeia standards orspecifications agreed by the manufacturer;5. May 2013Section E:Post-RegistrationProcessb) Samples of products Registered products by the Authoritymay be taken sampled and tested for compliance withofficial or pharmacopoeia standards or specifications agreedby the manufacturer. Labels and package inserts of thesamples will also be checked to ensure compliance to therequirements as approved.c) The Authority will take necessary action on products whichdo not conform to the standards/ specifications andrequirements in the form of warnings or recalls. If a samplefails to meet adequate specifications, the productregistration holder will be issued a warning. Unless thefailure is serious enough to justify recall of the product, Theproduct registration holder has up to thirty (30) days toidentify the source/ cause of quality defect and actions to betaken for to improvement quality.Memo from Center for PostRegistration of Product Bil(87)dlm.BPFK/17/SV/21.16,10 May 2013National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 495
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ATTACHMENT 1Drug Registration Guida
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PART IV: CLINICAL DOCUMENTSDrug Reg
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ATTACHMENT 2Drug Registration Guida
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APPENDIX 5:Drug Registration Guidan
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1. GENERAL INFORMATIONSDrug Registr
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Route of AdministrationTAMC(CFU/g o
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e) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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