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_01082016Please indicate the attachment name accordingly in the registration form.

Product Classification □ New Chemical Entity/Radiopharmaceutical Substance□ New Combination Product□ Supplemental Product

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)

1

REFERENCE NO:

No. Excipient Name Strength Function Overage Remarks1.2.3.4.5.

  

5. Animal Origin :YES/NO

Porcine

Bovine

OvineAnimal origin selected:No. Active / excipient Name Type of animal origin1.2.

6. Manufacturer (name & address)

:

(i) Contract manufacturer

: YES / NO

 

(ii) Repacker : YES / NOIf Yes , to submit

No. Repacker Name Repacker Address GMP Certificate(attachment)

Packaging Process(attachment)

1

7. Second Source : YES / NOIf Yes , to submit

    i. Letter of declaration : ii. Registration number : iii. Product Name of the First Source :

2

 

 

PART I - ADMINISTRATIVE DATA AND PRODUCT INFORMATION

 Section A: Product Particulars

A1. Name of Product :  

A2. Name and Strength of Active Substance(s)  

No. Active Ingredient Name Strength Overage Remarks12.

 Name and Strength of Excipient(s)

 

No. Excipient Name Strength Function Overage Remarks12345

A3. Dosage form : _______________ in form of ____________________________________________

3

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

:

   

         

4

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 group2nd Level Therapeutic subgroup3rd Level Pharmacological subgroup4th Level Chemical subgroup5th Level Chemical substance

No. Therapeutic Name Therapeutic Code1

:

Section B: Product Formula B1.1 Batch Manufacturing Formula

5

  Batch Size :    

  Unit :    

  List of Active Ingredient(s):-No. Active Ingredient Name Strength Overage Remarks1.2.

           List of Excipient(s):-

No. Excipient Name Function Strength Overage Remarks1.2.3.4.5.

         

B1.2 Attachment of Batch Manufacturing Formula Documentation

:

 

Section C: Particular of Packing No. Pack Size Measurement

TypeContainer Type

Container Type Description

Container TypeDescription

Barcode/Serial No.

Distributor Price(RM)

1.

2.

         

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 :

6

carton(attachment)

 D3. Proposed package insert

(attachment):

 D4.  Consumer Medicine Information Leaflet (English and Bahasa Malaysia) :

(attachment)

Section E: Supplementary Documentation 

E1.1 Product Owner :PRODUCT HOLDER

PRODUCT 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)

:

7

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) 

:  

8

         

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 Address1

E17 Other Manufacturer(s) Involved No.

9

Manufacturer

Address

12

 

E18 Store Address (* if any)

No. Store Name Address1

PART II - QUALITY

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)

 :  

   

10

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 Remarks12345

         

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) :

 

11

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) :

12

P9 Product Interchangeability /Equivalence Evidence (attachment)(if applicable)

 :

 

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)

   

       

PART III – NON CLINICAL DOCUMENT

Section A: Table of Contents  

Table of Contents (attachment) :     

13

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)  :

   

14

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)

:

15

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                                  :

16