REGISTRATION APPLICATION FORM FOR NEW DRUG PRODUCT
All electronic copy (attachment) in CD should be named according to this format:
ACTD No_ACTD Requirement_Product Name_Date eg P8_Stability Data_ABC Tablet 500mg_01082016
Please indicate the attachment name accordingly in the registration form.
Product Classification □ New Chemical Entity/Radiopharmaceutical Substance
□ New Combination Product
□ Supplemental Product
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Product Validation: Product Information
1. / Product Name / :2. / Dosage Form / : / ______in form of ______
If capsule form
(i) Source of capsule shell:
(ii) Colouring agent used in capsule shell:
No. / Colouring Agent
1.
3. / Active Ingredient(s)
No.
/ Active Substance
/ Strength
/ Overage
/ Remarks
/
1.
2.
4. / Excipient(s)
No.
/ Excipient Name
/ Strength
/ Function
/ Overage
/ Remarks
/
1.
2.
3.
4.
5.
5. / Animal Origin / : / YES/NO
Porcine
Bovine
Ovine
Animal origin selected:No items found.
No. / Active / excipient Name / Type of animal origin
1.
2.
6. / Manufacturer (name & address) / :
(i) Contract manufacturer / : / YES / NO
(ii) Repacker / : / YES / NO
If Yes , to submit
No.
/ Repacker Name
/ Repacker Address
/ GMP Certificate
(attachment)
/ Packaging Process
(attachment)
/
1
7. / Second Source / : / YES / NO
If Yes , to submit
i. Letter of declaration :
ii. Registration number :
iii. Product Name of the First Source :
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PART I - ADMINISTRATIVE DATA AND PRODUCT INFORMATION
Section A: Product ParticularsA1. / Name of Product / :
A2. / Name and Strength of Active Substance(s)
No.
/ Active Ingredient Name
/ Strength
/ Overage
/ Remarks
/
1
2.
Name and Strength of Excipient(s)
No.
/ Excipient Name
/ Strength
/ Function
/ Overage
/ Remarks
/
1
2
3
4
5
A3. / Dosage form : ______in form of ______
A4. / Product Description / :
A5.1 / Pharmacodynamics / :
A5.2 / Pharmacokinetics / :
A6. / Indication / :
A7. / Recommended Dose / :
A8. / Route of Administration / :
A9. / Contraindication / :
A10. / Warning and Precautions / :
A11. / Interactions With Other Medicaments / :
A12. / Pregnancy and Lactation / :
A13. / Side Effects / :
A14. / Symptoms and Treatment of Overdose / :
A15. / Storage Condition / :
A16. / Shelf Life / :
A17. / Therapeutic Code/ATC Code :
(if any)
Anatomical Therapeutic Chemical (ATC)
/
1st Level
/ Anatomical main group
/
2nd Level
/ Therapeutic subgroup
/
3rd Level
/ Pharmacological subgroup
/
4th Level
/ Chemical subgroup
/
5th Level
/ Chemical substance
/
No.
/ Therapeutic Name
/ Therapeutic Code
/
1
/ :
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Section B: Product Formula
B1.1 / Batch Manufacturing FormulaBatch Size / :
Unit / :
List of Active Ingredient(s):-
No.
/ Active Ingredient Name
/ Strength
/ Overage
/ Remarks
/
1.
/
2.
List of Excipient(s):-
No.
/ Excipient Name
/ Function
/ Strength
/ Overage
/ Remarks
/
1.
2.
3.
4.
5.
B1.2 / Attachment of Batch Manufacturing Formula Documentation / :
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Section C: Particular of Packing
No./ Pack Size
/ Measurement Type
/ Container Type
/ Container Type Description
/ Container Type
Description
/ Barcode/Serial No.
/ Distributor Price(RM)
/ Retail Price(RM)
/
1.
2.
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Section D: Label (Mockup) For Immediate Container, Outer Carton, and Proposed Package Insert
D1. / Label (mockup) for immediate container (attachment) / :D2. / Label (mockup) for outer carton
(attachment) / :
D3. / Proposed package insert (attachment) / :
D4.
/ Consumer Medicine Information Leaflet (English and Bahasa Malaysia) :
(attachment)
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Section E: Supplementary Documentation
E1.1 / Product Owner / : / PRODUCT HOLDERPRODUCT HOLDER & MANUFACTURER
MANUFACTURER
OTHERS
No.
/ Product owner
/ Address
/
1
E1.2 / Letter of Authorization From Product Owner (attachment) / :
E2.1 / Letter of Appointment of Contract Manufacturer From Product Owner (attachment) / :
E2.2 / Letter of Acceptance From Contract Manufacturer (attachment) / :
E2.3
/ Letter of Appointment of Repacker From Product Owner (attachment) / :
E2.4
E3 / Letter of Acceptance From Repacker (attachment)
Is the Active Ingredient(s) patented in Malaysia? (attachment) / :
: / YES / NO
E4 / Certificate of Pharmaceutical Product (CPP) (attachment) / :
E4.1 / Certificate of Pharmaceutical Product (CPP) Issuing Body / : / Country :
Issuing Body :
E4.2 / Is this product licensed to be placed on the market for use in the exporting country? / : / YES / NO
E4.3 / Is the product on the market in the exporting country? / : / YES / NO
E4.4 / Date of issue of Certificate of Pharmaceutical Product (CPP) / :
E4.5 / Date of expiry of Certificate of Pharmaceutical Product (CPP) / :
E5 / Certificate of Free Sale (CFS) (*if any) (attachment) / :
E5.1 / Certificate of Free Sale (CFS) Issuing Body / : / Country :
Issuing Body :
E5.2 / Date of issue of Certificate of Free Sale (CFS) / :
E5.3 / Date of expiry of Certificate of Free Sale (CFS) / :
E6 / Certificate of Good Manufacturing Practice (GMP)(* if any) (attachment) / :
E6.1 / Certificate of Good Manufacturing Practice (GMP) Issuing Body / : / Country :
Issuing Body :
E6.2 / Date of issue of Certificate Good Manufacturing Practice (GMP) / :
E6.3 / Date of expiry of Certificate Good Manufacturing Practice (GMP) / :
E7 / Summary of Product Characteristics (Product Data Sheet) (attachment) / :
E8 / Company Core Data Sheet (CCDS) :
(attachment)
E9 / Attachment of Protocol Analysis (attachment) * For Lab Evaluation / :
E10 / Attachment of Analytical Validation Report (if any) (attachment)
* For Lab Evaluation / :
E11.1 / Attachment of Certificate of Analysis for S (Batch 1) (attachment) / :
E11.2 / Attachment of Certificate of Analysis :
for S (Batch 2) (attachment) / :
E12.1 / Attachment of Certificate of Analysis for P (Batch 1) (attachment)
: / :
E12.2 / Attachment of Certificate of Analysis :
for P (Batch 2) (attachment) / :
E13 / Other Supporting Documents
(attachment) / :
E14 / Worldwide Registration Status
(attachment) / :
E15
E16 / Manufacturer Address
Importer(* if any) / :
List of importer(s):-
No.
/ Importer Name
/ Address
/
1
E17 / Other Manufacturer(s) Involved
No.
/ Manufacturer
/ Address
/ Manufacturing Type
/ GMP Certificate (attachment)
/
1
2
E18 / Store Address (* if any)
No.
/ Store Name
/ Address
/
1
PART II - QUALITY
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Section P: Drug Product
P1 / Description and Composition (attachment) / :P2.1 / Information on Development Studies (attachment) / :
P2.2 / Components of the Drug Product (attachment) / :
P2.3 / Finished Products (attachment) / :
P2.4 / Manufacturing Process Development (attachment) / :
P2.5 / Container Closure System (attachment) / :
P2.6 / Microbiological Attributes (attachment) / :
P2.6 / Compatibility (attachment) / :
P3.1 / Batch Manufacturing Formula
List of Active Ingredient(s)
No.
/ Active Ingredient Name
/ Strength
/ Overage
/ Remarks
/
1
List of Excipient(s):-
No.
/ Excipient Name
/ Strength
/ Function
/ Overage
/ Remarks
/
1
2
3
4
5
P3.2 / Manufacturing Process and Process Control (attachment) / :
P3.2.1 / Manufacturing Process Flowchart (attachment) / :
P3.3 / Control of Critical Steps and Intermediates (attachment) / :
P3.4 / Process Validation and / or Evaluation (attachment) / :
P4.1 / Specifications (attachment) / :
P4.2 / Analytical Procedures (attachment) / :
P4.3 / Validation of Analytical Procedures (attachment) / :
P4.4 / Justification of Specifications (attachment) / :
P4.5 / Excipient of Human and Animal Origin :
(Please attach statement from manufacturer on BSE/TSE risk)
P4.6 / Novel Excipients (if any) (attachment) / :
P5.1 / Specification (attachment) / :
P5.2 / Analytical Procedures (attachment) / :
P5.3 / Validation of Analytical Procedures (attachment) / :
P5.4 / Batch Analysis (attachment) / :
P5.5 / Characterisation of Impurities :
(attachment)
P5.6 / Justification of Specification(s)
(attachment) / :
P6 / Reference Standards or Materials
(attachment) / :
P7 / Container Closure System / :
(attachment)
P8 / Stability (attachment) / :
P9 / Product Interchangeability /
Equivalence Evidence(attachment)
(if applicable) / :
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Section S: Drug Substance
Please use the following form for API submission of New Drug Product:ACTIVE PHARMACEUTICAL INGREDIENT (API) SUBMISSION
REGISTRATION APPLICATION FORM FOR NEW DRUG PRODUCT (NDP) & GENERIC PRODUCTS (CONTAINING SCHEDULED POISONS: PARENTERAL & ORAL DOSAGE FORM)
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PART III – NON CLINICAL DOCUMENT
Section A: Table of Contents
Table of Contents (attachment) / :Section B: Non Clinical Overview
B1 / Overview of the Non-Clinical Testing Strategy (attachment) / :
B2 / Pharmacology (attachment) / :
B3 / Pharmacokinetics (attachment) / :
B4 / Toxicology (attachment) / :
B5 / Integrated Overview & Conclusions (attachment) / :
B6 / List of Literature Citations (attachment) / :
PART IV – CLINICAL DOCUMENT
Section A: Table of Contents
Table of Content (attachment) / :Section B: Clinical Overview
B1 / Product Development Rationale (attachment) / :
B2 / Overview of Biopharmaceutics (attachment) / :
B3 / Overview of Clinical Pharmacology (attachment) / :
B4 / Overview of Efficacy (attachment) / :
B5 / Overview of Safety (attachment) / :
B6 / Benefits & Risks Conclusions (attachment) / :
Section C: Clinical Summary
C1 / Summary of Biopharmaceutic Studies & Associated Analytical Methods (attachment) / :C2 / Summary of Clinical Pharmacology Studies (attachment) / :
C3 / Summary of Clinical Efficacy (attachment) / :
C4 / Summary of Clinical Safety (attachment) / :
C5 / Synopsis of Individual Studies (attachment) / :
Section D: Tabular Listing of all Clinical Studies
Tabular Listing of all Clinical Studies (attachment) / :Section E: Clinical Study Reports [In-House Synopsis]
Clinical Study Reports [In-House Synopsis] (attachment) / :Section F:
List of Key Literature References (attachment) / :Published Clinical Papers (attachment) / :
Latest Periodic Safety Update Report (PSUR) (attachment) / :
FEE PEMPROSESAN
1. Fee Pemprosesan (termasuk bayaran makmal NPRA) perlu dikemukakan bersama 2 salinan Borang BPFK 001 (boleh dimuat turun dari laman sesawang NPRA) setelah permohonan penyaringan
('screening') diluluskan.
(1) Produk yang mengandungi Satu (1) bahan aktif: RM 4,000.00 (Empat ribu ringgit sahaja)
(2) Produk yang mengandungi Dua (2) atau lebih bahan aktif: RM 5,000.00 (Lima ribu ringgit sahaja)
2. Semua jenis pembayaran hendaklah dibuat di atas nama ‘Biro Pengawalan Farmaseutikal Kebangsaan’
PERAKUAN PEMOHON
Saya yang bernama dan beralamat di bawah sebagai mewakili syarikat yang memohon mengaku bahawa :
1. Saya akan mematuhi semua peruntukan-peruntukan dalam Akta Jualan Dadah 1952 (Disemak 1989) dan Peraturan-Peraturan Kawalan Dadah dan Kosmetik 1984.
2. Semua kenyataan-kenyataan di atas dan lampiran-lampiran yang disertakan adalah benar.
3. Saya menyedari dan mematuhi peruntukan-peruntukan di dalam Akta Paten 1983.
4. Saya mengaku akan bertanggungjawab sepenuhnya terhadap produk ini.
Tandatangan Pemohon :
Nama Penuh Pemohon :
(Huruf Besar)
Nombor Kad Pengenalan :
Jawatan dalam Syarikat :
Nama dan Alamat Syarikat :
Cop Rasmi Syarikat :
No. Telefon :
No. Faks :
Alamat e mel :
Tarikh :
13