Email: hpi2017@fda.moph.go.th



378545634290Proposed submission scheduleMMMYYYYPre-submission ID No:0Proposed submission scheduleMMMYYYYPre-submission ID No:Pre-submission planning form for electronic submission for Thai FDA.Refer to manual for applicants completing a pre-submission planning form An applicant is encouraged to submit this form in order to facilitate the registration process.For the list of mandatory requirements, see link right121285Notes: The Pre-submission planning form (PPF) and required attachment should be submitted to HPI via central mailbox <hpi2017@fda.moph.go.th> 3 months prior to initial submission. Information on data requirements, including minimum content, format, and condition of an application, is provided in eCTD Module 1. Relevant technical guidelines are available on HPI website at product in this application form must be included in annual submission plan which has been submitted via HPI mailbox.00Notes: The Pre-submission planning form (PPF) and required attachment should be submitted to HPI via central mailbox <hpi2017@fda.moph.go.th> 3 months prior to initial submission. Information on data requirements, including minimum content, format, and condition of an application, is provided in eCTD Module 1. Relevant technical guidelines are available on HPI website at product in this application form must be included in annual submission plan which has been submitted via HPI mailbox.PART 1 Applicant and Product Details1.1 Applicant’s detailsApplicant NameLicensee NumberLicensee TypeChoose an item.Address for correspondencePrimary contactSecondary contactContact person Position Telephone numberMobile numberFax numberEmail address1.2 Product DetailsMedicinal Product Details ? Single active ingredient ? Multiple active ingredient ? Multiple component (e.g. supplied with a device)Active ingredient(s)StrengthDosage form*Trade name* Reference to the latest version of standard terms by European Directorate for the Quality of Medicines & Healthcare (EDQM) Foreign Stringent Regulatory Status (if any)CountrySubmission dateApproval dateIndicationUSAEUAustraliaJapanCanadaSwitzerlandWHOOthers ……………..Product tableRecord the details of all products affected by this application or under evaluation or previously approved by Thai FDA. e-IdentifierTrade nameActive Ingredient(s)StrengthDosage formPack Size/ ContainerApplication number/ Registration numberDate of Application/ Date of ApprovalRelation to this applicationResubmisison430195924411500Is this a resubmission? ? Yes ? NoIf yes, provide the application number of the previous application Rationale for re-submisison and cancelation details. 207037905601.3 Indication(s)Proposed filing in ThailandSmPC or Reference country LeafletIndication(s)Dosage Recommendation1.4 Application Type and Review MethodProduct Type ? Small molecule? Large moleculeApplication Type? Stand-alone application ? Mixed application? Hybrid medicinal product? Biosimilar or Similar Biological Product ? Extension of marketing authorization? Well established medicine ? Generic medicinal product: ? with BE study ? BE study not required ? Fixed combination ? Old + Old ? New + Old ? Others (please justify with reference guideline) ________________________________________________________Proposed Review Method? Full assessment? Abbreviated assessment (unredacted/full assessment report is required)? Expedited approval* (applicable to either full assessment or abbreviated assessment) ? Accelerated review ? Fast track review ? Priority Review* Please provide justification _________________________________________________________________Declaration of Differences in dossier if applicable(The differences that cause concern related to quality, safety, and efficacy of products) SectionThailand eCTDReference Country DossierAttached with comparison table for module 2-5 ? Yes ? No Attached with declaration from product owner in module 1.A.7 ? Yes ? No1.4.1 For similar biological medicinal product onlyIf a similar biological medicinal product, complete information on the reference medicinal product:Is the reference product registered in Thailand?? Y? NDoes the reference product have the same form, strength, and route of administration?? Y? NHave additional comparability studies been conducted?? Y? NHas the same INN as the reference product been requested?? Y? N Has attached SmPC / package insert of reference product (originator) which registered in Thailand?? Y? NReference product – active ingredientReference product – trade (proprietary) nameIf a similar biological medicinal product, complete information on the reference medicinal product:Is the reference product registered in Thailand?? Y? NDoes the reference product have the same form, strength, and route of administration?? Y? NHave additional comparability studies been conducted?? Y? NHas the same INN as the reference product been requested?? Y? N Has attached SmPC / package insert of reference product (originator) which registered in Thailand?? Y? NReference product – active ingredientReference product – trade (proprietary) name1.4.2 For generic drug only If a generic drug with BE study, complete information on the reference medicinal product:Was an overseas reference product used for bioequivalence studies? ? Y? NWas bioequivalence study conducted in Thailand? ? Y? NHas bioequivalence study been approved in Thailand? ? Y? N Has attached SmPC / package insert of reference product (originator) which registered in Thailand? ? Y? NReference product – active ingredientReference product – dosage form/strengthReference product – trade (proprietary) name& Thai registration number (if applicable) If a generic drug without BE study, complete information:? BE study is not required, please provide justification? BCS-based biowaiver, drug substances class: _______________________________________________? Others _______________________________________________________________________________ If a generic drug with BE study, complete information on the reference medicinal product:Was an overseas reference product used for bioequivalence studies? ? Y? NWas bioequivalence study conducted in Thailand? ? Y? NHas bioequivalence study been approved in Thailand? ? Y? N Has attached SmPC / package insert of reference product (originator) which registered in Thailand? ? Y? NReference product – active ingredientReference product – dosage form/strengthReference product – trade (proprietary) name& Thai registration number (if applicable) If a generic drug without BE study, complete information:? BE study is not required, please provide justification? BCS-based biowaiver, drug substances class: _______________________________________________? Others _______________________________________________________________________________1.4.3 Comparative table of Indication and Dosage Recommendation with Reference productProposed biosimilars/ generic drug leafletReference Product LeafletIndication(s)Dosage recommendation1.5 Reference country documentation (If available)Comparable Overseas Report (COR)AvailableDocumentation YesNoEuropean Medicines Agency (EMA)??Comprehensive details of all studies submitted and assessed ??Centralized procedure assessment report ??Day 80 Quality, Non-clinical, Clinical and overview Assessment report ??Day 120 List of Questions (and answer)??Day 150 Quality, Non-clinical, Clinical and overview Assessment report??Day 180 Joint Assessment Report ??Day 180 List of outstanding issues??Final Assessment report??Decentralized procedure assessment report ??All Assessment report ??Question from the regulator to the Market Authorization Holder (and response) ??Summaries of meetings with the EMA and/or assessors (including presubmission advice, where relevant)??Committee for Medicinal Products for Human Use (CHMP) Summary of Opinion??Any other questions from the regulator to the Market Authorization Holder??Letter of understanding ??European Commission Decision??Risk Management Plan review(s)??Post Marketing Review(s) e.g. Periodic Safety Update ReportsHealth Canada??Comprehensive details of all studies submitted and assessed ??Screening; Screening report??Clinical Review: Pharmaceutical Safety and Efficacy Assessment Report (PSEAR)??Quality: Quality Evaluation Summary (QES) and Manager’s Memo??Bioequivalence: Comprehensive Summary – Bioequivalence (CS-BE) and Manager’s Memo??Biostatistics: Biostatistics Consult report (If applicable)??Risk Management Plan Assessment report (If applicable)??Question from the regulator to the Market Authorization Holder (and responses)??Summaries of meetings with the Health Canada (including presubmission advice, where relevant)??Final Manager’s Memo and Executive SummaryMedicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom??Comprehensive details of all studies submitted and assessed ??All assessment reports as part of the iterative process??Question from the regulator to the Market Authorization Holder (and responses)??Committee for Medicinal Products for Human Use (CHMP) Summary of Opinion??Summaries of Other meetings with MHRA (including presubmission advice, where relevant) ??Approval letter??Post Marketing Review(s) e.g. Periodic Safety Update ReportsSwissMedic, Switzerland??Comprehensive details of all studies submitted and assessed ??All assessment report(s)??Question from the regulator to the Market Authorization Holder (and responses)??Summaries of Other meetings with SwissMedic (including presubmission advice, where relevant)??Approval letter??Post Marketing Review(s) e.g. Periodic Safety Update ReportsUnited States Food and Drug Administration (US FDA)??Comprehensive details of all studies submitted and assessed ??Medical review(s)??Chemistry review(s)??Pharmacology review(s)??Statistical review(s)??Clinical pharmacology biopharmaceutics review??Risk Assessment and risk mitigation review(s)??Administrative document(s) and correspondence??Cross discipline team leader review??Office Director Memo??Summaries of meetings with the US FDA (including presubmission advice, where relevant)??Summary review??Complete response letter??Approval letter??Post Marketing reviewsPharmaceuticals and Medical Devices Agency (PMDA, Japan)??Full assessment report (English version)Therapeutic Goods Australia (TGA)??Complete Clinical assessment reports, including assessment on the Question & Answer documents between the Sponsor & Agency and all annexes??Complete Chemistry and Quality Control Assessment Report, including assessment on the Question & Answer documents between the Sponsor & Agency and all annexes??Assessment reports and/ or documents pertaining to post-approval variations, if applicable. WHO Prequalification??Prequalification summary assessment reportIf applicants could not provide the documentation, justification is required.PART 2 Details of Application eCTD Module 1-5Comprehensive Table of Contents? Y? NDraft product Information (PI)Will the application result in a new or revised PI?? Y? N Attach a draft PI document (Physician Insert)? Y? NAttach a draft PIL document (Patient Insert)? Y? NDMF and CEP if applicable ? Y? N Active IngredientDMF Filing Number Active IngredientCEP Reference NumberAnnual plan Annual plan submission ? Y? NPharmacovigilance Will a risk management plan (RMP) be included in the application? ? Y? N If no RMP is to be included, attach a justification. ? Y? N3.2 S Drug Substance Manufacturer(s) Manufacturer nameAddressManufacturing step3.2 P Drug ProductManufacturer nameAddressManufacturing stepGMP Clearance* Approval Letter number or GMP clearance application numberExpiry Date* The details needed for overseas manufacturers.List of Attachments ................
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