Republic of the Philippines
Department of Health
OFFICE OF THE SECRETARY
JUL 0 1 2013
ADMINISTRATIVE ORDER,
No. 2013 - 002
SUBJECT: Adoption of the Association_of Southeast_Asian Nations
{ASEAN) Common Technical Dossier (ACTD) and Common
Technical Requirements (ACTR) for the Registration of
Pharmaceutical Products for Human Use
I. BACKGROUND
The ASEAN Consultative Committee for Standards and Quality
(ACCSQ) was formed by the ASEAN Economic Ministry in 1992 with the aim
of eliminating technical barriers to trade of goods and services in order to
facilitate the implementation of the Agreement on the Common Effective
Preferential Tariff (CEPT) Scheme and realize the ASEAN Free Trade Area
(AFTA) by 2015.
The 13" Meeting of the ACCSQ held in Manila in 1999 agreed that a
Pharmaceutical Product Working Group (PPWG) be set up to develop
harmonized schemes in pharmaceutical product regulation among the 10
ASEAN Member States to complement the objective of AFTA without
compromising quality, safety and efficacy of pharmaceutical products made
available,
Given the significant differences in the existing infrastructure and
technical and financial capacity of ASEAN Member States, the PPWG was able
to make considerable progress through the years. After series of meetings and
consultations among the national drug regulatory authorities and pharmaceutical
industries of the region, the PPWG was able to establish and adopt the ASEAN
Common Technical Dossier (ACTD) and ASEAN Common Technical
Requirements (ACTR). Both the ACTD and ACTR are currently in various
stages of implementation among ASEAN Member States.
U. RATIONALE
With the advent of free trade and globalization, the need for increased
efficiency in the regulation of pharmaceutical products has compelled many
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national drug regulatory authorities to seek harmonized approaches and enter
into mutual recognition agreements/cooperative schemes with each other. In
ASEAN, this led to the streamlining of structurally diverse regulatory systems
and policies, yet still taking into careful consideration each participating
country’s sovereign laws.
The harmonization of regulatory requirements for pharmaceutical
products among ASEAN Member States, with the adoption of the ACTD and
ACTR as a key component, can help enhance public health and welfare by
providing faster access to and increasing the availability of quality, safe and
efficacious pharmaceutical products, as this will reduce technical barriers posed
by regulations and facilitate intra- and inter-regional trade. This convergence
also intends to provide the foundation for establishing sound partnerships
among the regulatory authorities and the pharmaceutical industries, and a means
to leverage valuable resources.
STATEMENT OF POLICY
‘The Department of Health (DOH) shall:
‘A. Support the members of the Philippine Pharmaceutical Industry as
‘they adopt the ASEAN Common Technical Dossier (ACTD) and
ASEAN Common Technical Requirements (ACTR) in order to
penetrate the Southeast Asian market for pharmaceutical products;
B. Encourage the members of the Philippine Pharmaceutical Industry to
update their systems and technologies to conform to the ASEAN
standards and requirements, and provide them with relevant
technical information through the Food and Drug Administration
(FDA) in cooperation with the pharmaceutical industry associations.
OBJECTIVE
This Administrative Order intends to formally adopt and incorporate the
ACTD and ACTR into the national regulations and registration requirements of
pharmaceutical products.
SCOPE OF APPLICATION
This Administrative Order shall apply to all manufacturers, traders and
distributors (e.g. exporters, importers and wholesalers) of pharmaceutical
products. However, manufacturers, traders and distributors of single and
multiple-component vitamin and mineral products, traditional medicines, over-
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the-counter preparations, household remedies, medical gases and veterinary
products are not covered by this Administrative Order.
DEFINITION OF TERMS.
Definition of terms, acronyms and abbreviations shall follow the
definitions provided for by the Glossary used for the ACTD and ACTR, insofar
as they are not in conflict with the national laws of the Philippines, in which
case, the latter shall prevail.
‘These terms, acronyms and abbreviations shalll include:
1) ACTD or ASEAN Common Technical Dossier - the part of
tion application dossier that is common to all
2) ACTR or ASEAN Common Technical Requirements — a set of
written materials intended to guide applicants to prepare application
dossiers in a way that is consistent with the expectations of all
ASEAN Drug Regulatory Authorities (DRA).
IMPLEMENTING GUIDELINES
The following ASEAN harmonized documents for the registration of
pharmaceutical products are hereby adopted and incorporated into the national
regulations and registration requirements of pharmaceutical products, insofar as
they are not in conflict with the national laws of the Phi 7
A. ASEAN Common Technical Dossier (ACTD)
1. Glossary
2. Organization of the Dossier
a) Part I. Table of Contents, Administrative Data and Product
Information
= Section A. Introduction
= Section B. Overall ACTD Table of Contents
= Section C. Administrative Data and Product Information
Documents (e.g. Application Form, Letter of
Authorization, Certifications, Labeling, Prescribing
Information)
b) Part II. Quality Document
a
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\+ Section A. Table of Contents
= Section B. Quality Overall Summary
- Section C. Body of Data
c) Part III. Nonclinical (Safety) Document
- Section A. Table of Contents
= Section B. Nonelinical Overview
- Section C. Nonclinical Written and Tabulated Summaries
= Section D. Nonelinical Study Reports
- Section E, List of Key Literature References
4) Part IV. Clinical (Efficacy) Document
- Section A. Table of Contents
= Section B. Clinical Overview
= Section C. Clinical Summary
= Section D. Tabular Listing of All Clinical Studies
- Section E. Clinical Study Reports
= Section F. List of Key Literature References
B, ASEAN Common Technical Requirements (ACTR)
1. ASEAN Guidelines on Stability Study of Drug Product
2. ASEAN Guidelines on Submission of Manufacturing Process
Validation Data for Drug Registration
3. ASEAN Guidelines for Validation of Analytical Procedures
4, ASEAN Guidelines for the Conduct of Bioavailability and
Bioequivalence Studies
5. ASEAN Guidelines on Nonclinical (Safety) Document
6. ASEAN Guidelines on Clinical (Efficacy) Document
7. ASEAN Variation Guidelines for Pharmaceutical Products
The FDA shall make available the full and current version of the ACTD
and ACTR guidelines on its official website for reference and information of all
stakeholders. To further elaborate and give clarity to certain provisions of these
guidelines, the ASEAN Question and Answer (Q&A) documents that have been
agreed upon and adopted in previous ACCSQ-PPWG Meetings shall also be
posted.
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IX.
C. Flexibility Over and Above the ACTD
For innovative therapeutic products (including |New
Chemical Entities), biologics and generic products approved in ICH
(International Conference on Harmonization) _ member
countries/regions, the FDA shall accept registration applications
filed following the ICH Common Technical Document (CTD)
format, in lieu of the ACTD. It must be emphasized, however, that
certain sections of the I[CH-CTD shall still comply with the ASEAN
harmonized requirements (including drug product stability studies),
when applicable. Otherwise, other relevant intemationally accepted
guidelines may be used as reference.
ROLES AND RESPONSIBILITIES OF ALL STAKEHOLDERS
All information provided by the applicant in connection with an
application for registration of a pharmaceutical product for human use shall be,
to the best of his/her knowledge, true and correct and reflective of the complete
and current information available. The applicant shall be aware that if he/she
makes any misrepresentation or false entry, or willfully withholds any material
fact in connection with an application submitted to FDA, this shall be a ground
for the disapproval of the said application.
Moreover, the applicant (including the manufacturer, if different from
the applicant), shall be responsible for the quality, safety and efficacy of the
product. Whenever changes in the quality, safety and efficacy aspects of the
product are made during the course of its life cycle, the applicant has the
obligation to notify FDA in writing.
FDA shall evaluate all information provided by the applicant in support
of an application for registration within reasonable time, It shall then determine,
on the basis of the data available, if the pharmaceutical product for human use
sought to be registered meets FDA’s current standards for quality, safety and
efficacy. After the evaluation process, a regulatory decision shall be made on
the application for registration which shall be issued in the form of either a
marketing authorization, disapproval letter or notice of deficiency(ies).
REPEALING CLAUSE
All other Administrative Orders, Circulars, Memoranda or parts thereof
concerning pharmaceutical product registration inconsistent with
Administrative Order are hereby repealed.
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plsSEPARABILITY CLAUSE
In any case any provision of this Administrative Order is declared contrary
to law or unconstitutional, other provisions which are not affected thereby shall
remain in force and effect.
EFFECTIVITY
This Administrative Order shall be published in a newspaper of general
circulation and shall take effect beginning 01 July 2013,
Cie.
ENRIQUE T. ONA, MD
Secretary of Health
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