m

s iu
po
ym
S
ory
lat
FOOD AND DRUG

gu
Re
ADMINISTRATION

ug
Dr
AN
Ensuring Safety, Efficacy, and Quality of Drug Products in
the Philippines
SE
-A
an
aiw
7T

8/3/2017 1
01
 m
s iu
Presentation Outline

po
ym S
ory
I. The Food and Drug Administration

lat
gu
II. The Center for Drug Regulation and Research

Re
III. Drug and Drug Products

ug
Dr
IV. Regulatory Framework

AN
V. The Way Forward
-A
SE
an
aiw
7T

8/3/2017 2
01
 m
s iu
Legal Bases

po
ymS
ory
Republic Act No. 3720 (as amended) – Foods, Drugs and Devices,

lat
and Cosmetics Act

gu
Re
ug
Dr
AN
SE
-A
an
aiw
7T

8/3/2017 3
01
 m
s iu
Legal Bases

po
ymS
ory
Republic Act No. 6675 – The Generics Act of 1988

lat
gu
Re
ug
Dr
AN
SE
-A
an
aiw
7T

8/3/2017 4
01
 m
s iu
Legal Bases

po
ymS
ory
Republic Act No. 7394 – Consumer Act of the Philippines

lat
gu
Re
ug
Dr
AN
SE
-A
an
aiw
7T

8/3/2017 5
01
 m
s iu
Legal Bases

po
ymS
ory
Republic Act No. 8203 – Special Law on Counterfeit Drugs

lat
gu
Re
ug
Dr
AN
SE
-A
an
aiw
7T

8/3/2017 6
01
 m
s iu
Legal Bases

po
ymS
ory
Republic Act No. 9502 – Universally Accessible Cheaper Quality

lat
Medicines Act of 2008

gu
Re
ug
Dr
AN
SE
-A
an
aiw
7T

8/3/2017 7
01
 m
s iu
Legal Bases

po
ymS
ory
Republic Act No. 9711 – Food and Drug Administration (FDA) Act

lat
of 2009

gu
Re
ug
Dr
AN
SE
-A
an
aiw
7T

8/3/2017 8
01
 m
s iu
Legal Bases

po
ymS
ory
Republic Act No. 10354 – The Responsible Parenthood and

lat
Reproductive Health Act of 2013

gu
Re
ug
Dr
AN
SE
-A
an
aiw
7T

8/3/2017 9
01
 m
s iu
Legal Bases

po
ymS
ory
Republic Act No. 10918 – Philippine Pharmacy Act

lat
gu
Re
ug
Dr
AN
SE
-A
an
aiw
7T

8/3/2017 10
01
 m
s iu
Legal Bases

po
ymS
ory
Republic Act No. 7277 (as amended by RA 10754) – Magna Carta

lat
for Disabled Persons

gu
Re
Republic Act No. 9165 – Comprehensive Dangerous Drugs Act of

ug
2002

Dr
Republic Act No. 9994 – Expanded Senior Citizens Act of 2010

AN
Republic Act No. 10532 – Philippine National Health Research
SE System Act of 2013
-A
Republic Act No. 10747 – Rare Diseases Act of the Philippines
an

Republic Act No. 10767 – Comprehensive Tuberculosis

aiw

Elimination Plan Act

7T

8/3/2017 11
01
 m
s iu
po
FDA MANDATE

ym S
ory
PROTECT

lat
gu
Re
THE GENERAL PUBLIC

ug
Dr
AN
by ensuring the safety, efficacy, and
SE
-A
quality of health products
an
aiw
7T

8/3/2017 12
01
 m
s iu
BRIEF HISTORY

po
ym S
ory
2009

lat
gu
RA 9711

Re
1982 FDA Strengthening

ug
Dr
EO 851
1963 BFAD

AN
RA 3720 SE
Creation of FDA
-A
an
aiw
7T

8/3/2017 13
01
 m
FOOD AND DRUG

s iu
po
ADMINISTRATION

ymS
ory
lat
gu
Currently, FDA is headed by

Re
Ms. Nela Charade Galang-Puno

ug
as appointed by President Rodrigo Duterte.

Dr
AN
SE
-A
an
aiw
7T

8/3/2017 14
01
 m
s iu
po
ym
S
MISSION

ory
lat
To guarantee the safety, quality, purity, efficacy of

gu
health products in order to protect and promote the

Re
right to health of the general public.

ug
Dr
VISION
AN
SETo be an internationally recognized center of
-A
excellence in health product regulation by 2026.
an
aiw
7T

8/3/2017 15
01
 m
s iu
Quality Policy

po
ymS
ory
Our highest commitment is to ensure the safety, efficacy and

lat
quality of health products.

gu
Re
ug
Toward this end, we commit to maintain and establish science-

Dr
based policies based on national and international standards as

AN
the basis for regulatory policies, to continually improve and
SE
maintain our competencies in relation to our regulatory function,
-A
and to deliver quality public service with integrity and efficiency.
an
aiw
7T

8/3/2017 16
01
 m
s iu
po
ym
Ms. Nela Charade G. Puno, RPh
Director General

S
ory
Ms. Maria Lourdes C. Santiago, MSc,
Atty. Ronald R. De Veyra, MBA, CESO VI

lat
MM
Deputy Director General for Internal
Deputy Director General for Field Regulatory
Management

gu
Operations Office

Re
Atty. Jasper Racquel P. Atty. Emilio L. Ms. Jesusa Joyce Atty. Anabelle C. Ms. Deborah S. Engr. Annette B.
Atty. Katherine M.
Alberto H. Alvendia, CPA, Polig, Sr. N. Cirunay De Veyra Legaspi Tan

ug
Austria-Lock
Lascano, MBA-H MBA-H Director II, NL Director II, SL Director II, Visayas Director II, ME Director II, MW
OIC, LSSC
Director III, PPS Director III, AFS Cluster Cluster Cluster Cluster Cluster

Dr
AN
Engr. Bayani C. San Juan,
MSc, MNSA Pagayunan SE
Ms. Pilar Marilyn P.
Dr. Benjamin G. Co
Director IV, CDRR
Engr. Ana Trinidad F.
Rivera
-A
OIC, CDRRHR Director IV, CFRR Director IV, CCRR
an

KEY OFFICIALS
aiw
7T

8/3/2017 17
01
 m
The Center for Drug

s iu
po
Regulation and Research

ym S
ory
lat
gu
Re
Ensures the safety, efficacy, and

ug
Dr
quality of drug products
AN
SE
-A
an
aiw
7T

8/3/2017 18
01
 m
s iu
“Drug Products”

po
ym
S
ory
1. any article recognized in the official USP-NF, official

lat
HPUS, PP, PNDF, BP, EP, JP, IP, any national

gu
Re
compendium or any supplement to any of them;

ug
Dr
2. any article intended for use in the diagnosis, cure,

AN
mitigation, treatment or prevention of
SE
disease in humans or animals;
-A
an
aiw
7T

8/3/2017 19
01
 m
s iu
“Drug Products”

po
ym
S
ory
3. any article other than food intended to affect the

lat
gu
structure or any function of the human body or animals;

Re
4. any article intended for use as a component of any

ug
articles specified in clauses (1), (2) and (3) not including

Dr
AN
devices or their components, parts or accessories;
SE
-A
an
aiw
7T

8/3/2017 20
01
 m
s iu
“Drug Products”

po
ym
S
ory
lat
5. herbal and/or traditional drugs which are articles of

gu
plant or animal origin used in folk medicine which are:

Re
recognized in PNF

ug
i.

Dr
ii. intended for use in the treatment
or cure or

AN
mitigation of disease symptoms, injury or
SE
body defects in humans
-A
an
aiw
7T

8/3/2017 21
01
 m
s iu
“Drug Products”

po
Sym
ory
lat
5. herbal and/or traditional drugs which are articles of

gu
plant or animal origin used in folk medicine which are:

Re
iii. other than food, intended to affect the structure or

ug
Dr
any function of the human body

AN
iv. in finished or ready-to-use dosage form; and
SE
component of any of the articles
-A
v. intended for use as a
an

specified in clauses (i), (ii), (iii) and (iv)

aiw
7T

8/3/2017 22
01
 m
s iu
“Drug Products”

po
ym S
ory
1. New chemical entities 6. Traditionally-used

lat
2. Generic products herbal products

gu
Re
3. Biological products (including 7. Herbal medicines

ug
biosimilars and vaccines) 8. Medical gases

Dr
4. Household remedies 9. Veterinary Drugs

AN
5. Over-the-counter products 10. Stem Cell Products
SE
-A
an
aiw
7T

8/3/2017 23
01
 m
Drug Class

s iu
po
ym
S
1. New Chemical Entities under Monitored Release

ory
Not previously authorized for marketing for any pharmaceutical

lat
use

gu
2. Biotechnological Products (including biosimilars and

Re
vaccines)

ug
Any product of biological origin, prepared with biological

Dr
processes, derived from human blood and plasma, or

AN
manufactured by biotechnology consisting of substances of high
MW whose purity, potency, and composition cannot readily be
SE
determined by chemical or physicochemical analysis
-A
3. Generic Drugs
an
aiw

Intended to be interchangeable with the innovator product

7T

8/3/2017 24
01
 8/3/2017
01
7T
aiw
an
-A
SE
AN
Dr
ug
Re
gu
lat
ory
Sym
po
s iu
m
25
 m
Drug Class

s iu
po
ym
S
ory
4. Traditionally-used Herbal Products

lat
preparations from plant materials whose claimed application/s

gu
is/are based only on traditional experience of long usage which

Re
should be at least five (5) or more decades as documented in
medical, historical and ethnological literature

ug
Dr
AN
SE
-A
an
aiw
7T

8/3/2017 26
01
 m
Drug Class

s iu
po
Sym
ory
5. Herbal Medicines
finished, products that contain as active ingredient(s) aerial or underground

lat
part(s) of plants or any other plant material, or combination thereof, whether in

gu
the crude state or as plant preparations

Re
have specific therapeutic claim(s) intended for use in the diagnosis,

ug
alleviation, cure or treatment of disease, promotion of health or intended to
affect or modify the structure or any function of the body of humans or animals

Dr
AN
SE
-A
an
aiw
7T

8/3/2017 27
01
 m
Drug Class

s iu
po
Sym
ory
6. Household Remedies
containing pharmaceutical substances of common or ordinary use to relieve

lat
common physical ailments which may be dispensed without a medical

gu
prescription in original packages, bottles or containers, the nomenclature of

Re
which has been duly approved by FDA in the process of registration. A
household remedy preparation should have no history of or recognized

ug
adverse reaction after being marketed and used for at least twenty (20)

Dr
years according to its indication

AN
SE
-A
an
aiw
7T

8/3/2017 28
01
 m
Drug Class

s iu
po
ym
S
ory
7. Over-the-Counter Preparations

lat
drug products or preparations that can be dispensed even

gu
without the written order of a licensed physician or dentist

Re
ug
Dr
AN
SE
-A
an
aiw
7T

8/3/2017 29
01
 m
Drug Class

s iu
po
ym
S
ory
8. Medical Gases

lat
Any gas or mixture of gases intended for administration to

gu
patients for anesthetic, therapeutic, diagnostic, or prophylactic

Re
purposes, which may be manufactured in a liquefied, non-
liquefied, or cryogenic state and administered as a gas

ug
Dr
AN
SE
-A
an
aiw
7T

8/3/2017 30
01
 m
Drug Class

s iu
po
ym
S
ory
9. Veterinary Drugs

lat
any substance, including biological products, applied or

gu
administered to food producing, companion, aquatic, laboratory

Re
and exotic animals, whether used for therapeutic, prophylactic or
diagnostic purposes or for modification of physiological functions

ug
or behaviors

Dr
AN
SE
-A
an
aiw
7T

8/3/2017 31
01
 m
Drug Class

s iu
po
ym
S
ory
10.Stem Cell-Based Products

lat
Comprised of human cells, tissues, and cellular and tissue-based

gu
products (HCT/Ps) that are subject to Philippine FDA regulations

Re
ug
Dr
AN
SE
-A
an
aiw
7T

8/3/2017 32
01
 m
Benjamin G. Co, MD, FPPS,

s iu
FPSECP
Office of the Director

po
ym
Ma. Theresa Pia C. Yap, RPh
Melody M. Zamudio, RPh, MGM-ESP
Product Research and Standards
Licensing and Registration Division (LRD)

S
Development Division (PRSDD)

ory
Policy/Standards
Registration LRD Support

lat
Development and Licensing Section
Section Section
Advocacy Section

gu
Re
New Drug and
Clinical Research
L1 Unit Prescription
Section
Generics Unit

ug
Dr
Post-marketing
Vaccines and
Surveillance 1 L2 Unit
Biologics Unit
Section

AN
Post-marketing
SE
Surveillance 2
Section
OTC and Herbal
Preparations Unit
-A
an

Pharmacovigilance Veterinary Drugs

aiw

Section Unit
7T

PRSDD Support
8/3/2017 Post-Approval Unit 33
Section
01
 m
s iu
Citizen’s Charter

po
S ym
Type of Application Duration of Activity Type of Application Duration of Activity

ory
Licensing of drug 30 calendar days Product Variation Notification 72-hours (3-working
establishment days)

lat
Initial application 254 calendar days LTO Variation on the Addition/ 72-hours (3-working

gu
Renewal application 68 calendar days Deletion of Source(s) through days)

Re
Notification
Automatic Renewal 33 calendar days

ug
Extension of CPR Validity for 72-hours (3-working
application
Renewal Applications days)

Dr
CLIDP application 31 calendar days
Import Permit for Samples for 72-hours (3-working

AN
Variation application 52 calendar days Product Registration and days)
Certificate of 14 calendar days Development
Pharmaceutical Products SE Export Permit for Drug Samples 72-hours (3-working
-A
(CoPP) Used for Bioequivalence Studies days)
an

Certificate of Free Sale 14 calendar days Certification for Animal Feeds 72-hours (3-working
aiw

Export Certificate 14 calendar days and Feed Products days)

Sales Promotion Permit 72-hours (3-working
7T

8/3/2017
days) 34
01
 m
s iu
Licensed Drug Establishments

po
ym
0.07%

S
0.07% 1.00% Establishment Type Number
Manufacturer

ory
2.38% 1.15% Manufacturer 351

lat
Trader Trader 403

gu
Distributor 6195

Re
17.68% Distributor Drugstore 27204

ug
Retail Outlet for 834
Drugstore

Dr
Non-prescription
Retail Outlet for Non- Drug

AN
prescription Drug Contract Research 26
SE Contract Research
Organization
Organization
-A
Sponsor
Sponsor 26
an

77.64%
TOTAL 35039
aiw

As of December 2016
7T

8/3/2017 35
01
 m
s iu
Registered Drug Products

po
ym
Product Type Number

S
1.71% 2.02%
Drug (Human) 20512

ory
0.12%

lat
Human Drug Drug (Vet) 2201
9.32%

gu
Vet Drug Medical Oxygen 28

Re
ug
Medical Oxygen Traditional Medicine 404

Dr
Traditional Vaccine and Biological 478

AN
Medicine Products
Vaccine and
86.83% SE
Biological Products
TOTAL 23623
-A
an
aiw

As of December 2016
7T

8/3/2017 36
01
 m
s iu
Regulatory Framework

po
ym
S
ory
lat
Licensing Pre- Post-

gu
and Market marketing

Re
Inspection Assessment Surveillance

ug
Dr
AN
Communication, coordination, and collaboration
SE
-A
“standards of safety,
an
aiw

efficacy, and quality”

7T

8/3/2017 37
01
 m
Licensing and Inspection:

s iu
po
at par with international standards

Sym
ory
lat
gu
Good Manufacturing Practice → AO 2012-0008  52 Countries

Re
Good Distribution Practice

ug
→ AO 2013-0027  Worldwide

Dr
Good Storage Practice → AO 2013-0027  Worldwide

AN
Good Clinical Practice SE → FC 2013-018  Worldwide
-A
an
aiw
7T

8/3/2017 38
01
 m
Licensing and Inspection:

s iu
po
at par with international standards

ym S
ory
lat
gu
Re
ug
Dr
AN
SE
-A
an
aiw
7T

8/3/2017 39
01
 m
Licensing and Inspection:

s iu
po
process flow Receiving

S ym
ory
Evaluation

lat
gu
Re
With
For Yes
deficiencies
inspection?
Yes ?

ug
Issuance of No

Dr
No Inspection
NOD/LOD

AN
With
deficiencies
SE ?
Yes
-A
No
an

Issuance of
aiw

Issuance of LTO
NOD/LOD
7T

8/3/2017 40
Releasing
01
 m
Licensing and Inspection:

s iu
po
process flow

ym S
ory
lat
gu
Re
ug
Dr
AN
SE
-A
an
aiw
7T

8/3/2017 41
01
 m
Licensing and Inspection:

s iu
po
Requirements

ymS
ory
1. LTO Application form

lat
2. Proof of Business Name Registration

gu
Re
3. Site Master file

ug
Dr
4. Risk Management Plan

AN
5. Proof of Payment
-A
SE
an
aiw
7T

8/3/2017 42
01
 m
Pre-Market Assessment:

s iu
po
at par with international standards

ymS
ory
1. The conduct of clinical trials must comply with ICH GCP

lat
gu
Re
ug
Dr
AN
SE
-A
an
aiw
7T

8/3/2017 43
01
 m
Pre-Market Assessment:

s iu
po
at par with international standards

ymS
ory
2. Proof of safety, efficacy, and quality must pass the

lat
requirements of FDA

gu
Re
ug
Dr
AN
SE
-A
an
aiw
7T

8/3/2017 44
01
 m
Pre-Market Assessment:

s iu
po
at par with international regulatory schemes

ym
S
ory
Inspection of foreign drug → Eliminates “backyard

lat
→ AO 2013-0022
manufacturers

gu
manufacturing”

Re
ug
Dr
AN
Conduct of Bioavailability
SE → Generic interchangeability → FC 2016-019
and Bioequivalence Studies
-A
an
aiw
7T

8/3/2017 45
01
 m
Pre-Market Assessment:

s iu
po
process flow Receiving

Sym
ory
Pre-Evaluation

lat
Email NOD

gu
With

Re
deficiencies?
Yes

ug
Dr
Evaluation

AN
SE No With
Yes
-A
deficiencies?
an

Issuance of CPR NOD/LOD

aiw
7T

8/3/2017 46
01

Releasing
 m
Pre-Market Assessment:

s iu
po
Requirements

ym S
ory
Part I: Administrative Data and Product Information

lat
Application Form

gu
Re
GMP Certificate/LTO

ug
Supply Agreements

Dr
Labeling
AN
SE
Product Information
-A
an
aiw
7T

8/3/2017 47
01
 m
Pre-Market Assessment:

s iu
po
Requirements

ym
S
Part II: Quality

ory
lat
Drug Substance

gu
S1 General Information: general properties of the API

Re
S2 Manufacture: description of the API manufacturing process

ug
Dr
S3 Characterization: confirmation of the structure of the API

AN
S4 Control of Drug Substance: tests and specification for API
SE
S5 Reference Standard: standard for testing of API
-A
an

S7 Stability: stability of the API

aiw
7T

8/3/2017 48
01
 m
Pre-Market Assessment:

s iu
po
Requirements

ym
S
Part II: Quality

ory
lat
Drug Product

gu
P1 Description and Composition: description of product

Re
P2 Pharmaceutical Development: dev’t of formulation

ug
Dr
P3 Manufacture: manufacturing process of product

AN
P4 Control of Excipients: tests and specification for excipients
SE
P5 Control of Finished Product: tests and specification of product
-A
P6 Reference Standards or Materials: standard for testing
an

P7 Container Closure System: storage system of product

aiw

P8 Stability: stability of the API

7T

8/3/2017 49
P9 Proof of Interchangeability: BA/BE, biowaiver
01
 Postmarketing Surveillance

m
s iu
po
strengthened enforcement

ym
S
ory
1. Pharmacovigilance

lat
Safety monitoring of drugs on the market for unexpected

gu
health risks and informing the public of risks posed by specific

Re
drugs and other health products

ug
Dr
AN
SE
-A
an
aiw
7T

8/3/2017 50
01
 Postmarketing Surveillance

m
s iu
po
strengthened enforcement

ymS
ory
2. Monitoring, collecting, sampling and testing of drugs

lat
3. Audits and inspection of manufacturers/ distributors/ retail

gu
outlets

Re
ug
Dr
AN
SE
-A
an
aiw
7T

8/3/2017 51
01
 Postmarketing Surveillance

m
s iu
po
strengthened enforcement

ymS
ory
4. Advertisements and claims monitoring

lat
gu
Re
ug
Dr
AN
SE
-A
an
aiw
7T

8/3/2017 52
01
 Postmarketing Surveillance

m
s iu
po
strengthened enforcement

ymS
ory
5. Consumer reporting of ADR/complaints processing

lat
gu
Re
ug
Dr
AN
SE
-A
an
aiw
7T

8/3/2017 53
01
 Postmarketing Surveillance

m
s iu
po
strengthened enforcement

ymS
ory
6. Recall, labeling revision, restrictions on use, and other

lat
enforcement action

gu
Re
ug
Dr
AN
SE
-A
an
aiw
7T

8/3/2017 54
01
 m
Communication, Coordination,

s iu
po
and Collaboration

ym S
ory
1. International Collaboration

lat
gu
Re
ug
Dr
AN
SE
-A
an
aiw
7T

8/3/2017 55
01
 m
Communication, Coordination,

s iu
po
and Collaboration

ymS
ory
2. Alignment with other government agencies

lat
gu
Re
ug
Dr
AN
SE
-A
an
aiw
7T

8/3/2017 56
01
 m
Communication, Coordination,

s iu
po
and Collaboration

ymS
ory
3. Partnerships with professional associations and private

lat
institutions

gu
Re
ug
Dr
AN
SE
-A
an
aiw
7T

8/3/2017 57
01
 m
s iu
Way Forward

po
ym
S
ory
1. International and Local Collaboration

lat
 Regulatory alignment

gu
2. Reduce regulatory burden

Re
ug
 Risk-based approach

Dr
 Increase manpower complement

AN
 Upgrading of facilities
SE
-A
an
aiw
7T

8/3/2017 58
01