ASEAN Pharmaceutical Harmonization Guidebook 2013

Pharmaceuticals & Healthcare
Asia Pacific
ASEAN Pharmaceutical
Harmonization
ASEAN Economic Community
Baker & McKenzie's

ASEAN Pharmaceutical
Harmonization Guide
Editors' Note
Dear Valuable Clients,
ASEAN has the potential to become a key driver of the global
economic structure. With a total population of about 600 million
people, a combined GDP of US$ 2.1 trillion, an abundance of natural
resources and a well-educated workforce, regional economic
integration into a single market and production base will boost
ASEAN's competitive edge. As we move closer to the establishment
of the ASEAN Economic Community ("AEC") in 2015, the freer flow
of capital, goods, services, investment and people may substantially
change the way we do business and interact with our neighboring
countries.
To achieve the ASEAN's objectives, barriers such as the different
laws, rules, regulations and standards governing goods and services
need to be eliminated. As a result, a long-term, concerted effort to
harmonize different laws and standards was put in place with 13
sectors identified as areas of importance. Healthcare, including
pharmaceuticals and other relevant products, is one of these identified
sectors, where efforts to achieve harmonization are to be concentrated.
Baker & McKenzie, a law firm entrenched in the ASEAN, has rolled
out several AEC Pharma initiatives, including seminars, publications
and other communications, in response to this industry trend.
The AEC Seminar Spotlight on the Pharmaceutical Industry
brought together key regulatory authorities, investment specialists and
pharmaceuticals & healthcare clients to talk about current updates,
insights, opportunities and threats surrounding the AEC efforts. The
first leg of many took place in Bangkok in 2012, to be followed by
similar seminars in Manila, Singapore and Kuala Lumpur in 2013.
This ASEAN Pharmaceutical Harmonization Guidebook addresses

five key AEC harmonization issues and aims to provide information
on how to navigate your business through the ASEAN pharmaceutical
harmonization process. Included in the guidebook are majority of the
ASEAN member countries, namely, Cambodia, Indonesia, Lao PDR,
Malaysia, Myanmar, Philippines, Singapore, Thailand, and Vietnam.
We would like to extend our gratitude to all the contributors,
especially correspondent law firms, namely Sciaroni & Associates
and South East Asia Law Office, whom we have partnered with for
the Cambodia and Lao PDR chapters, respectively.
ASEAN has proven that it can endure economic challenges. This fact,
along with regional integration efforts, has not gone unnoticed by
international corporations and investors. An integrated ASEAN
market, particularly in the pharmaceuticals & healthcare industry,
with harmonized standards, registration and evaluation, mutual
recognition of qualifications and cross-border cooperation, will propel
companies to become more prominent players in the global landscape.
We hope that our seminars and publications serve as a useful resource
and we look forward to engaging you more on the AEC as we spot
opportunities and help your company gain the first-mover advantage.
Yours truly,
Peerapan Tungsuwan
Partner
Head, Asia Pacific Pharmaceutical & Healthcare Industry Group
ii
Contributors
Baker & McKenzie
INDONESIA
Daru Lukiantono
+62 21 515 4853
Daru.Lukiantono
@bakernet.com
Cahyani Endahayu
+62 21 515 4893 Ext.4893
Cahyani.Endahayu
@bakernet.com
MALAYSIA
Kherk Ying Chew
+60 3 2298 7933
KherkYing.Chew
@wongpartners.com
Sonia Ong
+60 3 2298 7931
Sonia.Ong
@wongpartners.com
MYANMAR
Saw Yu Win
+66 2 636 2000 X6001
SawYu.Win
@bakermckenzie.com
PHILIPPINES
Christina Macasaet-Acaban
+63 2 819 4947
Christina.Macasaet-Acaban
@bakermckenzie.com
Charles Veloso
+63 2 819 4954
Charles.Veloso
@bakermckenzie.com
SINGAPORE
Andy Leck
+65 6434 2525
Andy.Leck
@bakermckenzie.com
Ren Jun Lim

+65 6434 2721
Ren.Jun.Lim
@bakermckenzie.com
iii
THAILAND
Peerapan Tungsuwan
+66 2 636 2000 X4333
Peerapan.Tungsuwan
@bakermckenzie.com
Prim Uditananda
+66 2636 2000 X4330
Prim.Uditananda
@bakermckenzie.com
VIETNAM
Yee Chung Seck
+84 8 3520 2633
YeeChung.Seck
@bakermckenzie.com
Correspondent Law Firms

CAMBODIA
Bretton Sciaroni
Sciaroni & Associates
+855 (23) 21 0225
Brett@sa-cambodia.com
LAO PDR
Kitchrat Kontain
South East Asia Law Office
+856 980 2221
kk.seal@ymail.com
iv
Minh Ha Vu
+84 8 3520 2664
MinhHa.Vu
@bakermckenzie.com
Table of Contents
Editors' Note ......................................................................................... i
Contributors ........................................................................................ iii
ASEAN Pharmaceutical Harmonization ............................................. 1
AEC Pharmaceutical Questionnaire .................................................... 3
Cambodia ...................................................................................... 5
Indonesia ....................................................................................... 8
Lao PDR ..................................................................................... 12
Malaysia ...................................................................................... 14
Myanmar ..................................................................................... 17
Philippines .................................................................................. 20
Singapore .................................................................................... 24
Thailand ...................................................................................... 27
Vietnam ....................................................................................... 30
ASEAN Pharmaceutical Harmonization

In 2015, the ten countries which form ASEAN ("Association of
Southeast Asian Nations") will implement the ASEAN Economic
Community ("AEC") with the goal of creating a common economic
community in Southeast Asia, characterized by a single market and
production base. The establishment of this community has the
potential to substantially change the way we do business and interact
with our neighboring countries.
In order to achieve the ASEAN's objectives, there is a need to
eliminate the barrier of having different laws, regulations and
standards governing goods and services. Thirteen sectors have been
identified as areas of importance, where efforts to achieve
harmonization should be concentrated. The Healthcare industry,
including pharmaceuticals and other relevant products, has been
particularly identified as one of these 13 sectors.
The ASEAN Pharmaceutical Product Working Group ("PPWG"), the
regulatory body responsible for overseeing the ASEAN harmonization
efforts, has formally stated the following objective:
"To develop harmonization schemes of pharmaceutical regulations of
the ASEAN member countries to complement and facilitate the
objective of AFTA, particularly, the elimination of technical barriers
to trade posed by these regulations, without compromising drug
quality, safety and efficacy."
Through harmonization efforts, the PPWG envisions an ASEAN
pharmaceutical product, for which the same regulatory requirements
would apply for all ASEAN member countries. Its development
would encourage increased supplies by multinational companies to the
ASEAN region and presumably, increased supplies between members.
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If an ASEAN pharmaceutical product is achieved, ASEAN

manufacturers could have renewed unity and coherence as well as the
benefits of cost savings and greater economies of scale. These should
enable them not only to supply the needs of ASEAN markets more
quickly and effectively, but also to compete more vigorously in the
wider market of ASEAN +3 (i.e. ASEAN and its key partners, Japan,
South Korea and China).
Harmonization is the key to the success of the AEC. With the
establishment of the AEC, the ASEAN Free Trade Agreement
("AFTA") and the creation of the ASEAN pharmaceutical product,
there lies opportunities and challenges, especially for the
pharmaceutical and healthcare industry.
The ASEAN Pharmaceutical Harmonization Guidebook aims to
provide you an overview of the key harmonization issues in the
pharmaceutical industry for the various ASEAN jurisdictions, namely
Cambodia, Indonesia, Lao PDR, Malaysia, Myanmar, Philippines,
Singapore, Thailand and Vietnam.
Baker & McKenzie
AEC Pharmaceutical Questionnaire

To address the key harmonization issues in the pharmaceutical
industry, each of the ASEAN member countries responded to these
five questions:
1) What is the definition of a
"new drug"?
New drugs are defined differently

in the various ASEAN countries.
For instance, Thailand and
Cambodia have 7 "new drug"
categories, while other countries
have 2 or 3 categories only. It is
important to identify and
understand how new drugs are
defined for product registration
and/or application purposes.
2) What are the current

requirements and timelines
for pharmaceutical product
registrations?
The ASEAN has initiated

pharmaceutical harmonization
efforts, including the
development of the ACTR and
ACTD format for product
registration documents. However,
not all countries are at the same
pace in terms of implementation.
While some countries have fully
implemented the ACTR/ACTD
format, other countries have not
gone so far as strictly requiring
the ACTR/ACTD for
submissions.
3) Have the ASEAN Common

Technical Requirements
("ACTR") and ASEAN
Common Technical Dossiers
("ACTD") been
implemented? If not, when
can it be expected?
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4) What are the requirements for

pharmaceutical facilities?
In terms of the registration of

pharmaceutical facilities,
compliance with the
Pharmaceutical Inspection
Cooperation Scheme ("PIC/S")
standards is the end goal of the
ASEAN harmonization. Although
some countries have already
enforced this, not all countries
have fully adopted the PIC/S
compliance requirement.
5) Will there be a revision of

application files, which were
not in accordance to the
ACTD format?
Since not all ASEAN countries

have fully implemented the
ACTR/ACTD format for
documents, for some countries,
revisions for previous product
registrations may be required.
The desired outcome of the
ASEAN pharmaceutical
harmonization efforts is to have a
review and/or revision of
application files every five years
to ensure product quality and
validity. This differs from the
current status for the various
countries as some product
licenses do not expire.
To navigate your business through the ASEAN pharmaceutical

harmonization process, the responses to these five AEC questions aid
in identifying where the various ASEAN countries are in terms of
implementation as well as managing the needed preparations for
product registration submissions.
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Cambodia
1. What is the definition of a "new drug"?
Cambodia follows practices similar to other ASEAN countries,
such as Thailand.
According to the Department of Drugs and Food, a new drug
refers to drugs having at least one of the following qualities:
1) new chemical entity
2) new indication
3) new delivery system that affects
bioavailability/bioequivalence ("BA/BE")
4) new route of administration
5) new dosage form
6) new strength
7) new combination of:
i.
new chemical entities and new derivatives
ii. two registered chemical entities or more but not the same
as combination drugs already registered
iii. combination drugs already registered but of different
strength
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2. What are the current requirements and

timelines for pharmaceutical product
registrations?
Pharmaceutical product application files (innovative drugs and
generic drugs) must be submitted following ACTR and ACTD.
The timeline for registration of an innovative drug is
approximately three months and the timeline for registration of a
generic drug is approximately six months, starting from the day
the FDA issues an actual acknowledgement number.
3. Have the ACTR and ACTD been

implemented? If not, when can it be
expected?
On 1 March 2010, the ACTR/ACTD was implemented in
Cambodia.
Cambodia does not have an actual trial period but began voluntary
submission in 2008.
4. What are the requirements for

Local pharmaceutical manufacturing facilities must comply with
Good Manufacturing Processes ("GMP") standards (refer to
PIC/S), and must undergo training by the Ministry of Health.
However, according to the Department of Drugs and Food,
facilities established overseas need to submit full documentation,
including the Plant Master File, Plant Layout, latest GMP
Assessment Report and latest GMP Certificate as well as other
documents for consideration for certifying overseas
manufacturing facilities.
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5. Will there be a revision of application files,

which were not in accordance to the ACTD
format?
According to the Department of Drugs and Food, starting March
2010, pharmaceutical product licenses of currently registered
products must be revised according to the ACTR/ACTD (Part I
and II) format. A bioequivalence document must be submitted
along with the Quality documents for those Generic drugs in the
List of Molecules required for Bioequivalence Study and Quality
documents. The Non-clinical document (Part III) and Clinical
document (Part IV) must also be submitted for the registration of
New Chemical Entities ("NCE") and Biotech products.
Applications in the revised format may retain the existing
registration numbers. The result is that an application file will
need to be revised every five years as in other ASEAN countries.
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Indonesia
A "new drug" is a drug with a new active chemical entity, new
additive chemical, new dosage form/new route of administration,
new strength, or new combination that has not been approved in
Indonesia.

registrations?
Before registering drugs, the registrant should go through a preregistration process. A pre-registration process is conducted in
order to filter drug registrations, decide on the registration
category, evaluation line, evaluation cost, and decide on the
documents needed for drug registration.
The registration takes most time in the evaluation process,
depending on which evaluation line the drugs should go through.
There are 4 evaluation line categories, which are:
1) Forty (40) days line for:
a) Registration of minor variations that need approval;
b) Registration of drugs specialized for export
2) One hundred (100) days line for:
a) Registration of new drugs and biology products indicated

for serious illness therapy that:
i.
threatens human life (life saving), and/or
ii. is easily contagious to other people, and/or

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iii. does not have or there is a lack of choice for safe and
effective therapy;
b) Registration of new drugs and biology products, which
are, based on justification, indicated for serious and rare
illnesses (orphan drugs);
c) Registration of new drugs and biology products for public
health programs;
d) Registration of new drugs and biology products, which
have been through a development of new drug process
that is developed by a pharmacy industry or research
institution in Indonesia with all phases of the clinical tests
conducted in Indonesia;
e) New registration of essential generic copy drugs which
are completed with supporting documents for program
needs or supporting data as a generic drug;
f) New registration of copy drugs with electronic
information standards ("Stinel"), or
g) Registration of major variations of new indications/new
posology for drugs, intended for as mentioned in 2a, 2b,
2c and 2d;
h) Registration of major variations which are not included in
2g.
3) One hundred and fifty (150) days line for:
a) New registration of new drugs, biology products, and

registration of major variations of new indications/new
posology that has been approved in countries applying the
harmonized evaluation system and in countries with well
known evaluation systems.
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b) New registration of new drugs, biology products, and

posology that has been approved in at least three countries
with well known evaluation systems.
c) New registration of copy drugs without Stinel.
4) Three hundred (300) days line are for new registration of new
drugs, biology products, similar biology products, or
posology that are not included in the evaluation line stated in
item 2 and 3.
After submitting the registration form containing information
from the pre-registration process and enclosing the relevant
documents, the Head of the National Agency of Drug and Food
Control ("BPOM") will decide whether to accept or decline the
drug registration. In practice, it may take 12 to 18 months for
BPOM to issue a pre-market approval, starting from the day
BPOM issues an acknowledgement letter stating that the
application letter and the supporting documents have been
completely submitted.

expected?
ACTD has been implemented since 12 October 2011 through the
enactment of 2011 BPOM regulation on Criteria and Procedure of
Drugs Registration, which results in all drug registrations to
follow ACTD format as of that date. Whereas ACTR has been
implemented since December 2011 by the Indonesian government
through conducting national workshops and providing capacity
building.
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All pharmaceutical facilities must acquire a Pharmaceutical
Industry License. Starting 9 April 2012, all pharmaceutical
facilities must also comply with the updated requirement of GMP
(refer to CPOB) proven by the GMP Certificate, which is valid for
5 years.

format?
Application files which were submitted for registration before 12
October 2011 will still be processed based on the old format and
those which are submitted after such date will be processed based
on the ACTD format.
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Lao PDR
"New drugs" refer to drugs with the following qualifications:
1) Modern drugs or any traditional medicine, resulting in
positive effect
2) Not completely defined and mentioned in international
medical documents
3) Not registered in its country of origin
4) Registered for less than five years
5) Differs in formula, method of use, form, and packing from
drugs that have been registered

registrations?
Registration of a pharmaceutical product requires submitting an
application form and supporting documents following ACTR and
ACTD to the Department of Food and Drug ("FDD").
Registration of a pharmaceutical product normally takes
approximately six months upon the FDD confirming that the
application and all supporting documents have been duly received
by the FDD.
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expected?
The trial period for voluntary submission started in 2009. From
August 2011 onwards, the FDD has gradually imposed that
pharmaceutical application files must follow ACTR/ACTD.

GMP standards. For the overseas facilities that do not comply
with the GMP standards, they are required to submit the
manufacturing and product information to the FDD.

format?
It is not clear whether the application files approved prior to
August 2011 must be revised. However, it is obvious that all
applications filed from August 2011 onwards will follow ACTR
format, in which such applications are subject to be revised from
time to time in accordance with the ACTR format.
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Malaysia
The Drug Registration Guidance Document ("DRGD") issued by
the National Pharmaceutical Control Bureau ("NPCB") of the
Malaysian Ministry of Health defines "New Drug Product" or
"NDP" as one which has not been registered in accordance with
the Control of Drugs and Cosmetics Regulations 1984
("Regulations").
An NDP may fall under any one of the following categories:
1) New chemical entity (an active moiety that has not been
registered in any pharmaceutical product) or
radiopharmaceutical substance (a radionucleotide ligand or
the coupling mechanism to link the molecule and the
radionucleotide that has not been registered in any
pharmaceutical product).
2) New combination product - a new pharmaceutical product
containing two or more drugs that are physically, chemically
or otherwise combined or mixed and produced as a single
pharmaceutical product, in a combination that has not been
registered in any other pharmaceutical product.
3) Supplemental product - a new pharmaceutical product
containing a drug that has been previously registered as a
pharmaceutical product but differing in properties with regard
to safety and/or efficacy from the product that has been
previously registered.
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registrations?
Applications for registration of pharmaceuticals must be
submitted online to the Drug Control Authority ("DCA") via the
QUEST 3 system. Registration takes between 210 - 245 working
days from the date of final and complete submission of the
application to the NPCB. The registration is valid for five (5)
years or such other period as specified in the registration
certificate.

expected?
Yes, the DRGD incorporates the ACTR and ACTD.

Compliance with the DCA's GMP guidelines is a prerequisite for
the application of a manufacturing license, as well as product
registration. 'Manufacturing' is defined under the Regulations to
include (i) the making or assembling of the product, (ii) the
enclosing or packaging of a product in any container in a form
suitable for administration or application, and the labeling of the
container, and (iii) the carrying out of any process in the course of
any of the foregoing activities.
The DRGD states that a manufacturing site should comply with
current GMP standards. Local manufacturing sites are subjected to
pre-licensing inspections and for manufacturing sites outside
Malaysia, certification by the competent authority is sufficient.
However, the DCA reserves the right to conduct an inspection on
any manufacturing site.
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format?
There is no confirmation from the DCA whether applications
submitted prior to the implementation of ACTD and ACTR that
are not in ACTD format must be revised to comply.
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Myanmar
Drug is defined under the National Drug Law as a substance for
use, whether internal or external, in the diagnosis, prevention and
treatment of disease, birth control or for any beneficial effect in
human beings and animals.
"New drug" is not defined specifically in the National Drug Law.
The Myanmar Food and Drug Administration ("FDA") requires
updating changes to registered drugs to be made only with the
approval of the FDA. For example, changes to registered drugs
such as relevant data or findings from studies used as basis for the
justification of change, significant effect of changes to the
specification of drugs, changes to strength and dosage form.

registrations?
Drug registration applications must be filed to the FDA in a form
(Form 1 Registration) prescribed by the FDA following ACTD
for the registration of pharmaceuticals for human use.
Enquiring and getting approval of the FDA may take around six
months after submission of the completed Form 1 Registration
and documentation for common, established drugs, and
approximately nine months for less common drugs and non-new
chemical entities, and approximately 12 months for new chemical
entities.
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expected?
According to the current practice in applying for registration of
drugs, the FDA mandates that the standard ACTD has to be used
in connection with complete information of drugs accompanying
Form 1 Registration, when submitting them to the FDA.
Therefore, ACTD has been referred to by the FDA to be strictly
complied with.

GMP applies to the products which are categorized as medicine,
medical equipment, cosmetics or sanitation products in Myanmar.
Pursuant to the National Drug Law, the Myanmar Food and Drug
Board of Authority can, among others, determine good practices
for assurance of quality in respect of manufacturing, clinical tests
and laboratory analyses of the pharmaceutical raw material or
registered drug and all matters relating to drugs.
The National Drug Law requires a person who has been granted
the right to manufacture, import, export, store, distribute or sell
pharmaceutical raw material or registered drug to abide strictly by
the order, directive and conditions issued by the Myanmar Food
and Drug Board of Authority in respect of quality assurance of the
drug.
Moreover, according to "A Guideline on Drug Registration
Application (revised in February 2009)" prescribed by the FDA
(the "Guideline"), GMP certificate of manufacturing plant is also
required to be submitted to FDA, together with other relevant
documents such as: a) a product certificate issued by the
regulatory authority of its own country indicating that the product
is authorized to be sold in country of origin, b) properly endorsed
photocopy of valid manufacturing license, etc. Please also refer to
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answer in item 2, regarding good practices in manufacturing and

drug quality control.

format?
The Guideline mandates that the ACTD format has to be strictly
observed when applying for registration of drugs. The FDA does
not accept applications for registration of drugs which are not in
conformity with ACTD format.
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Philippines
A "new drug" refers to:
1) any drug which is not generally recognized, among experts
qualified by scientific training and experience to evaluate the
safety of drugs, as safe for use under the conditions
prescribed, recommended, or suggested in the labeling
thereof.
2) any drug, the composition of which is such that said drug, as a
result of investigations to determine its safety for use under
such conditions, has become so recognized, but which has not,
otherwise than in such investigations, been used to a material
extent or for a material time under new conditions.
The term "new drug" shall include drugs: a) containing a newly
discovered active ingredient; b) containing a new fixed
combination of drugs, either by molecular or physical
combination of drugs; c) intended for new indications; d) an
additional new mode of administration; or e) in an additional
dosage or strength of the dosage form, which meets the conditions
as defined under the new drug.

registrations?
Applications for registration of pharmaceutical products must be
submitted to the Food and Drug Administration ("FDA") in
accordance with the ACTD format. In addition, the following
documents must generally be submitted:
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1) Notarized Letter of Application;

2) Form No. 8, as prescribed by the FDA;
3) Distributorship Agreement over the product to be distributed /
imported;
4) Copy of valid License to Operate;
5) Unit Dose and Batch Formulation;
6) Technical specifications of all raw materials;
7) Certificate of Analysis of all active raw materials from the
manufacturer of the active raw material and from the
manufacturer of the finished product;
8) Technical specifications of the finished product;
9) Certificate of Analysis of the finished product;
10) Master manufacturing procedure, production equipment,
sampling and in-process controls, and master packaging
procedure;
11) Assay and other test procedures, including assay with data
analysis;
12) Stability studies;
13) Representative sample in market or commercial presentation;
14) Labeling materials, with actual color text;
15) Bioavailability / bioequivalence studies, where applicable;
16) Dissolution profile for certain drugs;
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17) For new drug applications, a copy of FDA's approval on preclinical, clinical and protocol for Monitored Release, the
rationale of Fixed Dose Combination Product (if applicable),
and Post-Marketing Surveillance ("PMS") or Letter of
Extension of Monitored Release Status (if applicable);
18) For imported products, original Certificate of Pharmaceutical
Product ("CPP"), issued at least one year from the date the
application for registration was filed, or, if CPP is not
available, Certificate of Free Sale from the country of origin,
duly authenticated by the Philippine consulate of the place of
execution, and a government certificate attesting to the
registration status of the manufacturer, duly authenticated by
the Philippine consulate of the place of execution;
19) For products contained in plastic container: general
information on the container, studies done on the plastic to
substantiate claim that the product is safe to use, test
procedure and limits, and empty plastic container and closure
with corresponding proof of payment for laboratory analysis;
20) Payment of registration fee.
The approval timeline for product registration is eight to 12
months, depending on the volume of work of the FDA, and the
applicant's submission of complete documentation or immediate
compliance with any additional requirements. Applications for
new drugs may take a longer period. New drug applications for
general use shall be issued either two or five years based on the
application of the company while renewal registrations are valid
for 5 years.

expected?
The FDA issued a circular in 2007, which stated that the
ACTD/ACTR will be fully implemented by January 2009.
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However, based on informal conferences with the FDA, it

confirmed that in practice, the FDA still accepts applications that
are not compliant with the ACTD/ACTR. It has been
communicated with Philippines regulators/health authorities that
ACTD/ACTR must be fully implemented by 2015.

Pharmaceutical facilities being referred to are drug establishments
engaged in the manufacturing, importation, exportation, sale, offer
for sale, distribution, donation, transfer, use, testing, promotion,
advertising, or sponsorship of health products, including the
facilities and installation needed for its activities.
Drug establishments are inspected using the PIC/S GMP Guides
as standard for Good Manufacturing Practice. On June 2012, full
implementation of the PIC/S GMP Guides created under the
ASEAN Mutual Recognition Agreement ("MRA") was adopted.
For compliance, a one year transition period starting from the
effectivity of the adoption was given. In addition, a drug
establishment must obtain a License to Operate from the FDA.
The requirements for obtaining a License to Operate will depend
on the activity the drug establishment is engaged in (as
manufacturer/repacker, trader, or importer).

format?
According to a responsible officer of the FDA, under the current
policy of the FDA, no revisions are required for applications not
made in accordance with ACTD format.
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Singapore
There are 3 different types of new drug applications ("NDA"):
1) NDA-1: For the first strength of a product containing a new
chemical or biological entity ("new" means it has not been
registered before in Singapore);
2) NDA-2:
(i) For the first strength of a new drug product:
containing a new combination of registered chemical or

biological entities;
containing registered chemical or biological entity/ies in a

new dosage form;
containing registered chemical or biological entity/ies for

use by a new route of administration; or
containing registered chemical or biological entity/ies for

new indication/s, dosage recommendation/s and/or patient
population/s.
(ii) For new drug products that do not fall under the
requirements for NDA-1, NDA-3 or generic drug
application ("GDA").
3) NDA-3: For subsequent strength/s of a new drug product that
has been registered or has been submitted as an NDA-1 or

NDA-2. The product name, pharmaceutical dosage form,
indication, dosing regimen and patient population shall be the
same as that for the NDA-1 or NDA-2.
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registrations?
Pharmaceutical product application files must be submitted
following either the International Conference on Harmonization
("ICH") CTD or the ACTD format. Timelines vary from 60 to
270 working days, depending on whether the submission is a
verification, abridged or full dossier submission.

expected?
Yes, they have been implemented since December 2005.

Documentary evidence must be provided to certify that the
manufacturer complies with current applicable GMP standards.
Applicants must submit a GMP certificate issued by a drug
regulatory agency for all drug product manufacturing sites
including, but not limited to, bulk product manufacturers, primary
packagers and secondary packagers.
All new overseas drug product manufacturing sites not previously
registered with the regulators before 1 April 2004 and who intend
to register their Western medicinal products in Singapore will be
subjected to a GMP Conformity Assessment.
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format?
Only if variation applications need to be submitted or if there are
changes to a product's efficacy, quality and/or safety.
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Thailand
"New drugs" refer to drugs with the following qualifications:
1) new chemical entity
2) new indication
3) new delivery system that affects
bioavailability/bioequivalence ("BA/BE")
4) new route of administration
5) new dosage form
6) new strength
7) new combination of:
i.
new chemical entities and new derivatives
ii. two registered chemical entities or more but not the same
as combination drugs already registered
iii. combination drugs already registered but with different
strength

registrations?
Pharmaceutical product application files for innovative drugs and
generic drugs must be submitted following ACTR and ACTD.
The registration timelines for innovative drugs and generic drugs
are roughly around 1.5 - 2 years and 8 - 10 months, respectively,
Baker & McKenzie
27
starting from the day the FDA issues an actual acknowledgement

number.

expected?
The trial period for voluntary submission started in 2003. On the
first day of January 2009 onwards, pharmaceutical application
files must follow ACTR/ACTD.

GMP standards (refer to Pharmaceutical PIC/S). Therefore,
overseas facilities must comply to these GMP standards as well.
From 1 October 2012 onwards, new overseas facilities who have
not yet had any pharmaceutical products registered with the FDA
prior to the date, must submit Plant Master File, Plant Layout,
latest GMP Assessment Report and latest GMP Certificate as
detailed in the FDA Notification on specification of application
form, format of the Certificate and other documents for
consideration of certifying overseas manufacturing facilities dated
17 October 2012.

format?
Currently, pharmaceutical product licenses do not expire. The
FDA will soon announce that around 20,000 application files
approved before 31 December 2008 are to be revised according to
ACTR/ACTD (parts: Administrative and Quality) as an update
and obsolete products will be eliminated. These revisions may be
in the form of the variations to keep the existing registration
28
Baker & McKenzie
numbers. The outcome is that an application file will need to be

revised every five years as in other countries.
Baker & McKenzie
29
Vietnam
"New drug" means a drug which is registered for the first time in
Vietnam, including:
1) drugs containing a new chemical entity; or
2) drugs with a new combination of substances which were
already circulated in Vietnam

registrations?
Application dossiers for drug registration for both innovative
drugs and generic drugs must be submitted following
ACTR/ACTD.
By law, the approval timeline for a newly registered drug or reregistered drug is six months from the date of submission of a
duly completed application dossier. However, in practice, this
approval process may take 8 to 12 months, depending on the
Ministry of Health's ("MOH") workload.
Approval timeline for both major variation and minor variation is
two months (by law). In practice it may take 3 to 6 months,
depending on the MOH's workload.
The Product registration number is valid for five years since the
date of issuance and can be renewed.
30
Baker & McKenzie

expected?
Starting 24 May 2010, all application dossiers for drug
registration must follow ACTD.

World Health Organization ("WHO") GMP is a mandatory
requirement for all local pharmaceutical manufacturers of (i)
chemical drugs since 1 July 2008 and of (ii) vaccine and medical
biologicals since 1 January 2011.
GMP certificate is valid for 3 years and can be renewed.

format?
For product registration application dossiers submitted before the
ACTD requirement (i.e., before 24 May 2010), once the product
registration numbers are expired, the company must submit the
application dossier under ACTD format for renewal. This includes
the data of method validation and manufacturing process
validation.
Baker & McKenzie
31
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Pharmaceuticals & Healthcare

Baker & McKenzie's

This ASEAN Pharmaceutical Harmonization Guidebook addresses

Ren Jun Lim

Correspondent Law Firms

ASEAN Pharmaceutical Harmonization

Baker & McKenzie

ASEAN Pharmaceutical Harmonization

If an ASEAN pharmaceutical product is achieved, ASEAN

ASEAN Pharmaceutical Harmonization

Baker & McKenzie

AEC Pharmaceutical Questionnaire

New drugs are defined differently

2) What are the current

The ASEAN has initiated

3) Have the ASEAN Common

Baker & McKenzie

ASEAN Pharmaceutical Harmonization

4) What are the requirements for

In terms of the registration of

5) Will there be a revision of

Since not all ASEAN countries

To navigate your business through the ASEAN pharmaceutical

ASEAN Pharmaceutical Harmonization

Baker & McKenzie

new chemical entities and new derivatives

Baker & McKenzie

ASEAN Pharmaceutical Harmonization

2. What are the current requirements and

3. Have the ACTR and ACTD been

4. What are the requirements for

ASEAN Pharmaceutical Harmonization

Baker & McKenzie

5. Will there be a revision of application files,

Baker & McKenzie

ASEAN Pharmaceutical Harmonization

2. What are the current requirements and

a) Registration of new drugs and biology products indicated

threatens human life (life saving), and/or

ii. is easily contagious to other people, and/or

ASEAN Pharmaceutical Harmonization

Baker & McKenzie

a) New registration of new drugs, biology products, and

Baker & McKenzie

ASEAN Pharmaceutical Harmonization

b) New registration of new drugs, biology products, and

3. Have the ACTR and ACTD been

ASEAN Pharmaceutical Harmonization

Baker & McKenzie

4. What are the requirements for

5. Will there be a revision of application files,

Baker & McKenzie

ASEAN Pharmaceutical Harmonization

2. What are the current requirements and

ASEAN Pharmaceutical Harmonization

Baker & McKenzie

3. Have the ACTR and ACTD been

4. What are the requirements for

5. Will there be a revision of application files,

Baker & McKenzie

ASEAN Pharmaceutical Harmonization

ASEAN Pharmaceutical Harmonization

Baker & McKenzie