Introduction to ACTD & Registration Requirements for China/Korea & ASEAN

1. REGULATORY REQUIREMENTS FOR
REGISTRATION OF DRUGS IN ASIAN COUNTRIES
Presented by –Vikas Rathee
M Pharm (DRA)
180000802005

2. • Introduction to ACTD
• Regulatory requirements of Registration of drugs in China
• Regulatory requirements of Registration of drugs in South
Korea
• ASEAN Region

3. ASEAN CommonTechnical Dossier
This ASEAN CommonTechnical Dossier (ACTD) is a guideline of the agreed
upon common format for the preparation of a well-structured Common
Technical Dossier (CTD) applications that will be submitted to ASEAN
regulatory authorities for the registration of pharmaceuticals for human
use.
This guideline describes a CTD format that will significantly reduce the
time and resources needed to compile applications for registration and in
the future, will ease the preparation of electronic documental submissions.
Regulatory reviews and communication with the applicant will be facilitated
by a standard document of common elements.

5. Sections of ACTD
PART I: Table of contents, Administrative Data & Product
Information(Applicable)
PART II: Quality Documents(Applicable)
PART III: Non Clinical Documents(Not Applicable for generic
products)
PART IV: Clinical Documents(Not Applicable for generic
products some exception may apply)

6. ACTD Guideline
Part I :Table of ContentAdministrative Information and Prescribing Information
Section A: Introduction
Section B: OverallASEAN CommonTechnical DossierTable of Contents
Section C: Documents required for registration (for example, application forms, labeling,
Product Data Sheet, prescribing information)
Part II : Quality Document
Section A:Table of Contents
Section B: QualityOverall Summary
Section C: Body of Data

7. ACTD Guideline
Part III : Nonclinical
Document
Section A:Table of
Contents
Section B: Nonclinical
Overview
Section C: Nonclinical
Written andTabulated
Summaries
Table of Contents
Pharmacology
Pharmacokinetics
Toxicology
Section D: Nonclinical
Study Reports
Table of Contents
Pharmacology
Pharmacokinetics
Toxicology

8. ACTD Guideline
• Part IV : Clinical Document
• Section A: Table of Contents
• Section B: Clinical Overview
• Section C: Clinical Summary
 Summary of Biopharmaceutics and Associated Analytical Methods
 Summary of Clinical Pharmacology Studies
 Summary of Clinical Efficacy
 Summary of Clinical Safety
 Synopses of Individual Studies
• Section D: Tabular Listing of All Clinical Studies
• Section E: Clinical Study Reports
• Section F: List of Key Literature References

9. REGISTRATION OF DRUGS IN CHINA
Main responsibilities (CFDA)
• The implementation and enforcement of pharmaceutical rules
and laws
• Regulations for all drug, food, supplement, medicaldevice,
and cosmetics in China
• The inspection, sales, research, and advertisement of drug,
food, supplement, medical device, and cosmetics products
• Drug approvals

10. • Drug Classification in China
• Chemical Drugs (small molecules):
• Total 6 Classes
• 2 classes are related to NCE
• Class 1: NCEs that have not been marketed in the world,
• Class 3: NCEs which marketed in outside China
• Biological Products:
• Total 15 Classes and all are considered as new drug
• Class 1: New biologics
• Class 2: Monoclonal Antibody
• Class 3: Gene therapy and cell therapy
• Traditional Chinese Medicines (TCM)
• Total 9 classes

11. The Requirements for New Drug Registration (including Import
Drug Registration)
Overview Summary
• Pharmaceutical Sciences (CMC)
• Non-clinical Pharmacological and Toxicological Research
• Clinical Research

12. • Two Application Steps
• Clinical Trial Application (CTA or IND)
• Marketing Application (NDA)
• Two Review Stages
• Provincial FDA Review:
• Dossier Content/Format Checking
• On-site Inspection
• China FDA (CFDA) Review
• Technical review by the Center for Drug Evaluation (CDE)
• Approval by CFDA

17. Drug Registration in South Korea
MFDS NIFDS

18. Drug Registration in South Korea
• Overview of Pharmaceutical Approval Process
• Approve pharmaceuticals whose safety, efficacy, and quality are identified (including
pharmaceutical ingredients) through technological review and inspection for their
manufacturing and distribution.
• Classification of pharmaceuticals : Drug products, pharmaceutical ingredients
• Classification of drug products : New Drug, Pharmaceutical required for data
submission and Generic Drug
• New Drug refers to a new material pharmaceutical whose chemical structure or
original composition is totally different from a pharmaceutical previously
approved in Korea
• Pharmaceutical required for data submission refers to not a new drug but a
pharmaceutical required for the safety and efficacy evaluation.
• Generic Drug refers to a pharmaceutical which is equivalent to a new drug
(reference drug) in terms of active ingredient, dosage form and strength.

19. Continue …
Investigational new drug approval application
“Investigational New Drug (IND) Application” refers to the process through
which an applicant who intends to execute a clinical trial using a drug in order
to demonstrate the safety and efficacy of the drug on humans applies for an
approval from the MFDS.

20. IND Approval Process

22. ASSOCIATION OF SOUTHEAST ASIAN NATIONS
• The ASEAN was founded on August 8, 1967.
• The Foreign Ministers of Indonesia, Malaysia, the Philippines, Singapore
and Thailand – sat down together in the main hall of the Department of
Foreign Affairs building in Bangkok, Thailand and signed a document. By
virtue of that document, the Association of Southeast Asian Nations
(ASEAN) was born.

24. ASEAN
• ASEAN is a regional grouping that promotes economic, political, and
security cooperation among its ten members: Brunei, Cambodia, Indonesia,
Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand, and
Vietnam.
• In 1976, the members signed the Treaty of Amity and Cooperation,
emphasizing ASEAN's promotion of peace, friendship, and cooperation to
build solidarity.

25. To accelerate the economic growth, social
progress and cultural development in the
region through joint endeavors in the spirit
of equality and partnership in order to
strengthen the foundation for a prosperous
and peaceful community of Southeast
Asian Nations.
To promote regional peace and stability
through abiding respect for justice and the
rule of law in the relationship among
countries of the region and adherence to
the principles of the United Nations
Charter.

26. To promote active collaboration and mutual assistance on matters of common interest in the
economic, social, cultural, technical, scientific and administrative fields.
To provide assistance to each other in the form of training and research facilities in the
educational, professional, technical and administrative spheres.
To collaborate more effectively for the greater utilization of their agriculture and industries,
the expansion of their trade, including the study of the problems of international commodity
trade, the improvement of their transportation and communications facilities and the raising
of the living standards of their peoples.
To promote SoutheastAsian studies.
To maintain close and beneficial cooperation with existing international and regional
organizations with similar aims and purposes, and explore all avenues for even closer
cooperation among themselves

29. Selected References :
1.Asean.org. (2019). [online] Available at:
https://asean.org/storage/2017/03/68.-December-2016-ACTD.pdf [Accessed 1
May 2019].
2. - China CFDA (sfda) Approval - Pharmaceuticals CFDA Register-China
FDA,SFDA,CFDA,MOH,MOA,AQSIQ,CNCA,CIQ registration approval license
for cosmetics , health food supplement , medical device ,IVD ,drug , infant
milk powder ,dairy , pet food ,disinfectant etc. [Internet]. Sfdachina.com. 2019
[cited 1 May 2019]. Available from: http://sfdachina.com/infosort/11_1.htm
3. [Internet]. 2019 [cited 1 May 2019]. Available from:
http://www.mfds.go.kr/eng/
4. ASEAN | ONEVISION ONE IDENTITY ONE COMMUNITY [Internet]. ASEAN
| ONEVISION ONE IDENTITY ONE COMMUNITY. 2019 [cited 1 May 2019].
Available from: https://asean.org/