Submitted by:

BALLADA, Theodore Daniel

DUNGCA, Ma. Katrina
FERNANDO, Andrea
TIONGSON, Maria Gabriela

Second Batch - July 2017

University of Santo Tomas
SCENARIO:
Wellness Healthcare, a company located at Hyderabad, India,
specializes in mAbs, has expressed their interest to market
MABTHERA in the Philippines.

TASK:
Show the different steps in order to register the product.
In each step, include the different applications involved.
 Steps in order to register
SIMILAR BIOTHERAPEUTIC/BIOSIMILAR
(mAbs) product
 Steps in order to register
SIMILAR BIOTHERAPEUTIC/BIOSIMILAR (mAbs) products
STEP 1: Partnership with Local Company

- Contract of agreement
- Requirements and procedures for registration of LTO

STEP 2: GMP Clearance

- Requirements and application procedures

STEP 3: Product Registration

- Requirements and application procedures

 STEP 1: Partnership with Local Company
 Find a local MAH (Marketing Authorization Holder) in the Philippines that
can market MABTHERA (of Wellness Healthcare).
- Local MAH should be registered at FDA strictly with LTO.

 Through the local MAH the product MABTHERA can now be registered and
marketed in the Philippines.

MAH – Marketing Authorization Holder

FDA – Food and Drug Administration
LTO – License to Operate
 STEP 1: Partnership with Local Company
• Contract of agreement (SAMPLE)
 STEP 1: Partnership with Local Company
• Contract of agreement
 STEP 1: Partnership with Local Company
•Requirements and procedures for registration of LTO

Requirements:
• Accomplished and duly notarized Petition Form and Joint Affidavit of Undertaking;
• List of products to be distributed, identified by generic names and brand names intended for use;
• Copies of Pharmacist Board Registration Certificate, PRC ID, valid PTR, ID picture, and Duties and Responsibilities;
• Certificate of Attendance of owner or pharmacist to an FDA seminar on Licensing of Drug Establishments;
• Certificate of Registration with SEC and Articles of Incorporation/Partnership (for corporations or partnerships);
• Certificate of Business Name Registration with DTI (for single proprietorships);
• Locational plan and floor plan (office and storage room) with dimensions; and
• Contract of lease for the space to be occupied.


Importer
• Foreign Agency Agreement (FAA) from each supplier, duly authenticated by the Territorial Philippine Consulate
• Certificate of Registration of manufacturer and its conformity with the Good Manufacturing Practices From Health Authority
authenticated by the Philippine Consulate
PRC – Professional Regulation Commission
PTR – Professional Tax Receipt
SEC – Securities and Exchange Commission
DTI – Department of Trade and Industry
FAA – Foreign Agency Agreement
 STEP 1: Partnership with Local Company
•Requirements and procedures for registration of LTO

Requirements:


Requirements for verification during inspection:
• Reference materials:
– Philippine National Drug Formulary (latest edition)
– R.A. 3720: Foods, Drugs, Devices & Cosmetics Act
– R.A. 6675: Generics Act of 1988 and Relevant Implementing Rules and Regulations
– R.A. 5921: Pharmacy Law as amended and Relevant Implementing Rules and Regulations
– Latest edition of United State Pharmacopoeia/National Formulary (USP/NF), or Remington’s Pharmaceutical
Sciences, or Goodman & Gilman’s The Pharmacological Basis of Therapeutics

• Batch Distribution Record Book

USP – United State Pharmacopoeia

NF – National Formulary
 STEP 1: Partnership with Local Company
• Requirements and procedures for registration of LTO

Procedure:

• Submit application requirements to FDA;

• Proceed with interview with the Food and Drug Registration Office (FDRO);
• Review of completion of requirements and application by the Licensing Department;
• Receive Order for Payment and complete application;
• Request for schedule of inspection;
• Physical inspection of office and facility by the FDRO;
• Approval of the LTO by the Director; and
• Release of documents to applicant.

FDRO – Food and Drug Registration Office

FDA – Food and Drug Administration
LTO – License to Operate
 STEP 2: GMP
Clearance
•Requirements and application procedures
Administrative Order No. 2013-0022
FDA Circular No. 2014-016  NOTES:
 
REQUIREMENTS:  All documentary requirements must be in PDF format to
be submitted to PAIR
For Foreign GMP Evidence Evaluation  Existing image file format shall be followed
 A hard copy of the letter of request is required
1) Letter of Request  
2) GMP Evidence  PAIR (Public Assistance Information and Receiving)
3) Annex B In charge of the following:
4) Annex C (for non-PIC/s countries)
5) Annex E  Receiving of applications
6) Assessment Slip  Releasing of GMP Clearance/Notices/Denial

PAIR – Public Assistance Information and Receiving

GMP – Good Manufacturing Practice
 STEP 2: GMP
Clearance
• Requirements and
application procedures
APPLICATION PROCESS  PAIR (Public Assistance Information and Receiving)
 

1. SUBMISSION: GMP EVIDENCE EVALUATION In charge of the following:

The following should be submitted: Payment
- Letter of Request Electronic Submission
- Assessment Slip
- GMP Evidence
- Annex B
 CDRR (Center for Drug Regulation and Research)
- Annex E
In charge of the following:
- Annex C (for non-PIC/s)
Storage of application
Scheduling, assigning, and decking of applications
PAIR – Public Assistance Information and Receiving
GMP – Good Manufacturing Practice
CDRR – Center for Drug Regulation and Research
 STEP 2: GMP
Clearance
• Requirements and -Minor Deficiencies
application procedures -Notice to apply for Foreign Manufacturer GMP
Inspection
APPLICATION PROCESS
 

2. EVALUATION
-GMP Evidence 4. RELEASING
-GMP Dossier (where applicable) ICTMD (Information Communication Technology
-Other aspects of evaluation Management Division)
*Completeness -In charge of the following:
*Fraudulent, misrepresentations,falsified Scanning
  Endorsement to PAIR for release

ICTMD – Information Communication Technology

Management Division
GMP – Good Manufacturing Practice
 STEP 2: GMP
Clearance
• Requirements and • FROO and applicant (Field Regulatory Operation Office)
application procedures • FROO (Field Regulatory Operation Office)
In charge of the following:
1) foreign GMP Inspection
 FOREIGN GMP INSPECTION PROCESS: 2) coordinate with the local establishment for logistics and
scheduling
1. SUBMISSION: Foreign GMP Inspection 3) forward to CDRR the result of inspection with recommendation
(1) Letter of Request 4) Committee decision
(2) Notice to Apply
(3) Assessment Slip
(4) Annex D
(5) Annex C (where applicable)

 Payment: P3,000.00 + LRF (per application per importer per

site)
 
CDRR – Center for Drug Regulation and Research
GMP – Good Manufacturing Practice
FROO – Field Regulatory Operation Office
 STEP 2: GMP
Clearance
• Requirements and 4. RELEASING
application procedures ICTMD (Information Communication
Technology Management Division)
In charge of the following:
 FOREIGN GMP INSPECTION PROCESS:
- Scanning
3. REGULATORY DECISION - Endorsement to PAIR for release
CAPA (Corrective and Preventive Action)
-Recommendation for GMP Clearance
-Recommendation for Letter of Denial with reapplication
after six months

CAPA – Corrective and Preventive Action

ICTMD - Information Communication Technology Management
Division
GMP – Good Manufacturing Practice
PAIR – Public Assistance Information and Receiving
 STEP 2: GMP
Clearance
• Requirements and application procedures

Files/Forms/Downloadables for GMP Clearance (from FDA)

- List of Requirements for Foreign GMP Clearance (See attached file here)
- Foreign GMP Inspection Presentation (See attached file here)
- Assessment Slip Foreign GMP Clearance (See attached file here)
- Annex B = Request for GMP Evidence Evaluation Form (See attached file here)
- Annex D = Application form for Foreign Manufacturer GMP Inspection (See attached file here)
- Annex E = Affidavit of Undertaking (See attached file here)

GMP – Good Manufacturing Practice

 STEP 3: Product
Registration
• Requirements and application procedures  Duration of Activity: 68 calendar days
 Drug Regular Registration Application (See attached file here)
 INTEGRATED APPLICATION FORM
 CDRR (Center for Drug Regulation and Research)  Integrated Applicatom Form format (See attached file here)
 Front Line Service: Issuance of Certificate of Product Registration
(Regular Renewal)  CLIENT/APPLICANT ACTION:
• Download checklist of requirements for product
 Clients: All Manufacturers, Distributors, Importers, Exporters, registration from the FDA website (www.fda.gov.ph),
Wholesalers, and Traders of Pharmaceutical Products
submit application to Public Assistance, Information
 Requirements: Bureau Circular No.5, s. 1997 and Receiving (PAIR) Unit.
Administrative Order No. 67, s. 1989 • ACTD CHECKLIST FOR INITIAL REGISTRATION/SPECIFIC
REQUIREMENTS FOR mAbs (See attached file here)
Administrative Order No. 47-A, s. 2001
• Wait for schedule of PAIR.
Administrative Order No. 184, s. 2004
• Pay FDA fees.
Administrative Order No. 2013-0021 • Submit documents.
FDA Circular No. 2013-014
FDA Circular No. 2013-018
FDA Circular No. 2013-004
 Fees: A.O. 50 s. 2001* + Legal Research Fee (LRF)

FDA – Food and Drug Administration

PAIR – Public Assistance Information and Receiving
A.O. – Administrative Order
mAbs – Monoclonal Antibodies
 STEP 3: Product
Registration
• Requirements and application procedures Evaluates the product application according
to the requirements.

In case of approval, prepare worksheet for

FDA EVALUATION Certificate of Product Registration (CPR). In
case of Notice of Deficiency (NOD)/Letter of
AGENCY ACTION: Denial (LOD), prepare letter.
Pre-evaluates application based on the type
of application and completeness of Reviews the evaluated application with
documentary requirements. recommendation.

Assigns the application to the evaluators

through first in, first out system and relevant
memorandum.

Shares application for evaluation (e-copy).

Decks the application to the assigned

evaluators.
DTS – Document Tracking System
CPR – Certificate of Product Registration
Receives the product application using the
NOD – Notice of Deficiency
LOD – Letter of Denial
 STEP 3: Product
• Requirements and application procedures
Registration
 CPR (Certificate of Product Registration)
 LTO and CPR App Process Flowchart (See attached file here)
 CLIENT/APPLICANT ACTION:
• Proceed for the issuance of assessment slip.
• Proceed for the issuance order of payment.
• Proceed for payment.
• Proceed for submission of CPR application
(hardcopy and e-copy requirements).
• Technical evaluation.
• Proceed for the release of CPR.
CPR – Certificate of Product Registration
DTS – Document Tracking System
LRD – Licensing and Registration Division
NOD – Notice of Deficiency
LOD – Letter of Denial
ICTMD - Information Communication Technology Management
Division
 AGENCY ACTION:
• Encodes the CPR.
• Checks and affixes initial.
• Detaches the CPR from the documents and forward to
Licensing and Registration Division (LRD) Chief.
• Checks and affixes initial.
• Document Tracking of the application before
endorsement to Center OIC/Director.
• Signs CPR/LOD.
• Document Tracking of the signed application.
• In case of approval, endorses CPR to ICTMD for
scanning. In case of NOD/LOD, endorses letter to
Central Releasing.
• Scans and forwards to Central Releasing.
• Releases the CPR/NOD/LOD to client and updates DTS.
 STEP 3: Product
Registration
• Requirements and application procedures

Files/Forms/Downloadables for GMP Clearance (from FDA)

- Checklist of Requirements for Similar Biotherapeutics/Biosimilars/mAbs (See attached file here)

- LTO and CPR Application Process Form (See attached file here)
- Drug Regular Registration Application (See attached file here)
- Integrated Application Form (See attached file here)

CPR – Certificate of Product Registration

LTO – License to Operate
mAbs – Monoclonal Antibodies