REFERENCE MATRIX

By: Cuachon, Arljayn Joy

Central Philippine University
arljaync@gmail.com

PRODUCT TYPE New Generics Herbal

Drugs Medicine
LEGAL BASIS
Certificate of Product Registration (CPR) of Pharmaceutical Products Except Cancer Drugs
(New Chemical Entities)

This Certificate of Product Registration is granted to Marketing Authorization Holders of

chemical or synthetic drug products (except cancer drugs) classified under Monitored Release
either as a New Drug/New Chemical Entity or a pharmaceutical/therapeutic innovation of a
Tried and Tested/Established Drug (i.e., involving use for a new indication, a new mode of
administration, a new dosage form, and/or a new fixed-dose combination of two or more active
ingredients) upon compliance to the agency-prescribed Quality, Safety, Efficacy standards. It is
the approval granted by FDA to market a specific product in the country.

Certificate of Product Registration (CPR) of Pharmaceutical Products (Initial – Generic Drugs

Except Cancer Drugs)

This Certificate of Product Registration is granted to Marketing Authorization Holders of

prescription generic drugs (except cancer drugs) upon compliance to Quality, Safety, Efficacy
standards. It is the approval granted by FDA to market a specific product in the country.

Certificate of Product Registration (CPR) of Pharmaceutical Products (Initial – Herbal Medicine)

The issuance of a Certificate of Product Registration is granted to Marketing Authorization

Holder of Herbal Medicines and Traditionally Used Herbal Product which meets the standards
for Quality, Safety and Efficacy/Claimed Benefit of their product based on the provided
documentation. It is a marketing approval that the FDA grants for the sale and distribution of
such product in the country.

REQUIREMENTS
Sec. A Introduction
ASEAN Common Technical Dossier

Sec. B Overall ASEAN Common Technical Dossier Table of

Contents
Sec. C Guidance on the Administrative Data and Product
Information
1. Integrated Application Form (with proof of payment)
2. Letter of Authorization (where applicable)
For contractmanufacturing:
a.License of pharmaceutical industries and
contract manufacturer
b.Contract manufacturing agreement
c. GMP certificate of contract manufacturer
Part I: For manufacturing “under-license”
a.License of pharmaceutical industries
Administrative b.GMP certificate of the manufacturer
Data and c. Copy of “under-license” agreement
Product 3. Certifications For locally manufactured products:
Information a.License of pharmaceutical industries
b.GMP certificate (country specific)

For imported products

a.License of pharmaceutical
industries/importer/wholesaler (country
specific)
b.Certificate of Pharmaceutical Product
(CPP) issued by the competent authority in
the country of origin according to the current
WHO format
c. Foreign GMP Clearance
 4. Site Master File
5. Labeling
6. Representative Sample with corresponding Certificate of
Analysis
a. Package Insert
b. Summary of Product Characteristics (Product Data Sheet)
Part II: Sec. A Table of Contents

Quality Sec. B Quality Overall Summary

Sec. C Body of Data

S 1 General Information S 1.1. Nomenclature

S 1.2. Structural Formula
S 1.3. General Properties
S 2 Manufacture S 2.1. Manufacturer(s)
S 2.2. Description of Manufacturing
Process and Process Controls
Drug Substance S 2.3. Control of Materials
(S) S 2.4. Control of Critical Steps and
Intermediates
S 2.5. Process Validation and/or
Evaluation
S 2.5. Process Validation and/or
Evaluation
S 3 Characterization S 3.1. Elucidation of Structure and
Characteristics
S 3.2. Impurities
S 4 Control of Drug S 4.1. Specifications
Substance S 4.2. Analytical Procedures
S 4.3. Validation of Analytical
Procedures
S 4.4. Batch Analyses
S 4.5. Justification of Specifications
S 5 Reference Standards or Materials

S 6 Container Closure System

S 7 Stability

P 1 Description and Composition

P2 P 2.1. Information on Development Studies

Pharmaceutical
P 2.2. Components of the Drug Product
Development
P 2.3. Finished Product
P 2.4. Manufacturing Process Development
Drug Product
(P)
P 2.5. Container Closure System
P 2.6. Microbiological Attributes

P 2.7. Compatibility

P3 P 3.1. Batch Formula

Manufacture
P 3.2. Manufacturing Process and Process
Control
P 3.3. Controls of Critical Steps and
Intermediates
P 3.4. Process Validation and/or Evaluation
P 4 Control of Excipients

P 5 Control of Finished Product

P 6 Reference Standards or Material

P 7 Container Closure System

P 8 Product Stability
 P 9 Product Interchangeability/Equivalence Evidence (if
applicable)
Sec. A Table of Contents
Part III:
Nonclinical Sec. B Nonclinical Overview
Document
Sec. C Nonclinical Written and Tabulated Summaries

Sec. D Nonclinical Study Reports

Sec. E List of Key Literature References

Sec. A Table of Contents

Sec. B Clinical 1. Product Development Rationale

Overview 2. Overview of Biopharmaceutics
Part IV: Clinical
Document 3. Overview of Clinical Pharmacology
4. Overview of Efficacy
5. Overview of Safety
6. Benefits and Risks Conclusions
Sec. C Clinical Summary

Appendix 1 Summary of Clinical Pharmacology Studies

Appendix Appendix 2 Summary of Clinical Efficacy

Appendix 3 Summary of Clinical Safety

1. Integrated Application Form

2. Proof of Payment

3. Valid agreements between the manufacturer, trader, importer, distributor, where applicable

4. Unit Dose and Batch Formulation

5. Technical Specifications of all Raw Materials

6. Certificate of Analysis of active Raw a. From supplier of Active Raw Material

Material(s)
b. From manufacturer of finished product
c. Certification of Authenticity of Plant
Specimen from the National Museum or any
FDArecognized Taxonomist
7. Technical Specifications of Finished Product

8. Certificate of Analysis (CA) of Finished Product from the same batch of representative
sample)
9. Manufacturing Procedure, Production Equipment, Sampling, In-process controls, and Master
Packaging Procedure (including specification for container closure system)
10.Assay and Other Test Procedures including Identity, Purity Tests, with Data Analysis, where
applicable
11.Stability Studies

12.Labeling Materials (facsimile)

13.Evidence of Safety and Efficacy

14.Representative Sample (upon request of the evaluator)

1. For herbal medicines validated by the National Integrated Research Program on

ADDITIONAL

Medicinal Plants (NIRPROMP), Copy of the Memorandum of Agreement between

NIRPROMP and the applicant; otherwise, a copy of approval of FDA Committee
on the registration of the said herbal medicine

2. For products in plastic container: Certificate of Analysis for Test of Migratable

Substances/ Leachability

3. For imported products: Certificate of Pharmaceutical Product (CPP), Foreign

GMP Clearance, Valid LTO (Importer/Manufacturer/Distributor/Trader)
 FEES Required
Php 20,000.00/3 years

Php 3,000.00/year

Initial fee: Branded + 500.00

+ 1% LRF

Initial fee: Unbranded Php 2,000.00/year

+ 1% LRF

Clinical review + Php 5,000.00

Post-Marketing Surveillance Protocol Review + Php 2,500.00 + 1% LRF

2 year-validity: Branded Php 6,000.00 + 500.00= 6,500.00 + 1%

2 year-validity: Unbranded Php 4,000.00 + 1% LRF

5 year-validity: Branded Php 15,000.00 + 500.00= 15,500.00 + 1%

LRF
5 year-validity: Unbranded Php 10,000.00 + 1% LRF

TIMELINES Days= 180 days in total

STEP 1 Endorses the received application to the Center (applications which satisfactorily Day 1-2
passed the preassessment). Day 2 Day 2
STEP 2 Receives the application from FDAC and encodes/updates the database. Day 2

STEP 3 Queuing time of the application before decking to evaluators of Registration Day 2-46 Day 2-21 Day 2-21
Section and Clinical Research Section.

STEP 4 Decks/Assigns the application to the assigned evaluators of Registration Section Day 47 Day 21 Day 21
and Clinical Research Section.

STEP 5 Evaluates the application according to requirements and prescribed standards Day 48- Day 22- Day 22-141
147 119

STEP 6 Reviews the evaluated application bearing the recommendation of the Junior Day 148- Day 120- Day 142-163
Evaluator (for Quality evaluation). 167 166

STEP 7 Prepares the final output document (CPR/LOD), affixes initial, and forwards it to Day 164
the senior evaluator (FDRO III). If with post-approval commitment/s, prepares a
letter, signs, and forwards it together with the CPR. Day 168 Day 167
For Dangerous Drugs, prepares a letter/notification to PDEA for the approval of the
application
STEP 8 Reviews the final output document, affixes initial on the worksheet, and forwards it Day 168 Day 165-167
to the Section Supervisor

STEP 9 Reviews the final output document, affixes initial on the worksheet, and forwards it Day 169- Day 169- Day 168-170
to the Licensing and Registration (LRD) Chief. 171 171

STEP 10 Checks and recommends the decision of the evaluators and supervisor by affixing Day 172- Day 172- Day 171-173
signature. 174 174

STEP 11 Signs and approves the final decision Day 175 Day 175 Day 174

STEP 12 Encodes/Updates the Database and Endorses the final output document to the Day 176- Day 176- Day 175-176
CDRR-Records Section 177 177

STEP 13 Scans and endorses the final output document to the AFS - Releasing Section Day 178- Day 178- Day 177-179
179 179

STEP 14 Releases the CPR/LOD/letter to the client Day 180 Day 180 Day 180