The document discusses Thailand's drug registration and control system. It provides details on: 1) The organizational structure of Thailand's Food and Drug Administration (FDA) and its drug control divisions that are responsible for pre-and post-marketing activities like inspections, monitoring, and surveillance. 2) Thailand's drug registration process which requires licensees to obtain licenses before selling, manufacturing, or importing drugs. The registration ensures safety, efficacy and quality. 3) Different categories of drugs and their registration processes, timelines, and requirements. Priority review is given to drugs addressing public health issues. 4) Ongoing efforts to strengthen regulatory capacity, encourage compliance, and facilitate access through various initiatives and

1. PENDAFTARAN DAN KENDALI OBAT - OBATAN
8/12/2010
SIRIPORN CHAWANON
Ahli Obat, Divisi Pengendalian
Obat,Administrasi Obat dan
Makanan Thailand Tingkat
Professional 1

2. OUTLINE
8/12/2010 2
• Sistem Kendali Obat
• Organisasi dari Divisi Pengendali Obat
• Pendaftaran dan Membuat Surat Izin
Obat
•Sistem Pendaftaran Obat
•Program Monitor Keamanan

3. SISTEM KENDALI OBAT
8/12/2010 3
KEMENTRIAN KESEHATAN MASYARAKAT
ADMINISTRASI MAKANAN DAN OBAT -
OBATAN (FDA) DEPARTMENT ILMU
KESEHATAN KANTOR PROVINSI
THAI FDA
 PRE-MARKETING: SURAT IZIN PENDAFTARAN
OBAT
 POST-MARKETING:INSPEKSI
PENGAWASAN
ADR MONITORING

4. 8/12/2010 4
Bagan Organisasi dari Divisi Kendali Obat
DIVISI KENDALI OBAT
Seksi Pengembangan
Sistem Dan Kebijakan
Seksi Obat
Umum
Seksi
Obat Baru
Seksi Produk
Biologi
Seksi Obat
Tradisional dan Herbal
Bagian Hubungan
Internsional
Seksi Pengendali
Periklanan
Seksi Daftar
Pengembangan Esensial
Obat Nasional
Bagian Obat
Hewan
Bagian Industri Produk Generik dan
Bagian Kekayaan Intelektual
Sub- Divisi Administratif

5. 8/12/20105
Sistem Peraturan Thailand
Dasar legislatif dari sistem ini adalah
UU Narkoba BE 2510 (1967) dan
amandemen

6. Thai Regulatory System
8/12/20106
Undang-Undang Narkoba menetapkan bahwa
keputusan Sekretaris Jenderal, FDA, dibuat atas
saran Dewan Obat yang terdiri dari Direktur
Jenderal Departemen Utama yang relevan di
dalam MoPH serta perwakilan dari organisasi
terkait, ditambah lima hingga sembilan ahli obat.
Dewan Obat bertemu setiap bulan dan dapat
memberikan rekomendasi atau pendapat tentang
keputusan lisensi dan registrasi seperti disetujui,
ditarik atau ditangguhkan lisensi.

7. Surat Izin
(Lisensi)
8/12/20107
Undang-Undang Narkoba
mengharuskan orang yang ingin
menjual, memproduksi, atau
mengimpor obat-obatan ke Thailand
harus mendapatkan lisensi dari
FDA.

8. Pendaftaran
8/12/20108
• Orang yang memenuhi syarat dan
kriteria : Lisensi resmi
• Untuk memastikan kemanjuran
keamanan dan kualitas obat
• Setelah menerima Sertifikat Registrasi
Obat, obat tersebut dapat dipasarkan
secara sah.

9. DRUG REGISTRATION AND APPROVAL
8/12/20109
Bagian Obat BaruObat Baru dan Obat Generik Baru
(Untuk Penggunaan Manusia )
Obat Umum (Untuk Penggunaan
Manusia)
Bagian Obat Baru
Biological Product SectionBiological Products
(for human or veterinary uses)
Veterinary Drugs Veterinary and Pharmaceutical chemicals Section
(not include Biological Products and Traditional and Herbal Drugs)
Traditional and Herbal Drugs Traditional and Herbal Medicine Section
(for human or veterinary uses)

10. DRUG REGISTRATION PROCESS
8/12/201010
Applicants: Only authorized licensees are qualified to apply for
product registration.

Manufacturing plants :GMP compliance
2 steps:
Step 1: Application for permission to manufacture or import of
drug samples – One Stop Service Center
Step 2: Application for product registration approval

11. Flow Chart of Drug Review Process
8/12/201011
ApplicantApplicant
ApplicationApplication
Pre-filing screening ReviewPre-filing screening Review
Review by Experts/Subcommittee/CommitteeReview by Experts/Subcommittee/Committee
Make Decision by FDAMake Decision by FDA
ApprovedApproved RevisedRevised RejectedRejected
[Completeness Review]
[Technical Review]

12. Thai FDA Classified modern medicine into 3 categories :
8/12/201012
 New drugs
 New generic drugs: Pharmaceutical products with the
same active ingredients, doses and dosage forms as
those of new compounds (new drugs) registered after
1992 but manufactured by different manufacturers
 Generic drugs.

13. Thai FDA Classified modern medicine into 3 categories :
8/12/201013
 New drugs: registrations is the most stringent of all
require a complete set of product dossiers
 Generic drugs. The registrations require basically
dossiers on product manufacturing and quality
control together with product information.
 New generic drugs: In addition to the required
dossiers for generic submission, the new generic
registrations require dossiers of bioequivalence
studies as well as literature documents for
supporting safety and efficacy

14. ASEAN HARMONIZATION PRODUCT i.e.
8/12/201014
 ACTR , ACTD
 4 Technical Guidelines
(1) Analytical Validation guideline
(2) BA/BE Studies guideline
(3) Process Validation guideline
(4) Stability Study

15. Process of New Drug Registration
8/12/201015
Track 1 : Standard Review
210 - 280 working days
Track 2 : Accelerated or Priority Review
(Drugs for public health problems / life
threatening)
100-130 working days

16. Process of New Generic Drug Registration
8/12/201016
Track 1 : Standard Review
110 working days
Track 2 : Accelerated or Priority Review
(Drugs for public health problems / life
threatening)
70 working days

17. New Drug Registration (ASEAN Harmonization)
8/12/201017
ASEAN Common Technical Dossiers (ACTD)
Documents to be submitted 4 Parts
Part 1: Administrative Data and Product Information
Part 2: Quality Document
Part 3: Nonclinical Document
Part 4: Clinical Document

18. New Drug Registration System
8/12/201018
Step I
New Drug
Experts/Subcommittee
Approval
Conditional approval
SMP & Limited distribution (2 yrs)
Unconditional approval
Step II
Voluntary Spontaneous ADR Reporting System

19. Conditional Approval
8/12/201019
 Safety Monitoring Program (SMP) will be
conducted for approx. 2 years.
 Drug packages must bear labeling to
show conditional approval status.
should
monitori
 Triangle shows monitoring statusn
.g
 Specially-control drug
Limited distribution only through
medical institutes or hospitals

20. Objectives:
• To confirm the drug safety in Thai
patients
• To generate earlier safety signals and
gather more safety information of new
drugs before granting and unconditional
approval.
• To more rigorously control the usage of
new drugs
Why SMP?
8/12/201020

21. Objectives:
• To encourage physicians, pharmacist
and other health professionals to have
more concerns on the safety of new
drugs and their usage.
Why SMP? (2)
8/12/201021

22. • Capacity building on drug evaluation and
registration in order to be prepared for ASEAN
Pharmaceutical Harmonization and WHO
assessment of regulartory system.
• Collaboration and communication links with other
NRAs in order to strengthen professional
competence and exchange information (MOU with
TGA, US FDA Regulator Training Program for
vaccine)
• BE study submitted for registration should be
conducted in compliance with the ICH GCP as well
as GLP standard.
What Have Been Currently Done ?
8/12/201022

23. • Encourage current and new domestic manufacturer
to upgrade their quality standard.
• The proposed revision of Drug Act is
expected to bring about better drug
regulatory implications
• One Stop Service Center has been
established for submitted applications which
can be processed and approved within a
short time period.
What Have Been Currently Done ?
8/12/201023

24. • Maintain a balance between ensuring a product is
safe, efficacious and of good quality and not
delaying public access to the products.by Clearly
separate the tracks of registration submission into
standard review and priority review and Reduce the
timelines for each steps were announced.
What Have Been Currently Done ?
8/12/201024

25. 25
the public health’s
problem
1. The fast track pathway for the emergent medicine, such as,
neoplastic, H.I.V., antituberculous drug, antiviral
vaccine, can reduce the consideration period from 280
working days to 130 working days.
2. Thailand's MoPH issued a compulsory license for HIV
drug (EFFAVIRENZE, lopinavir/ritronavir) and drug for
other diseases with public health consequences such as
cancer or other chronic
8/12/2
d010
iseases (letrozole Imatinib errotinib docetaxel

26. 3. The personnel’s efficiency should be more
developed and improve competence
4. the ASEAN Economic Ministers signed the ASEAN
Sectoral Mutual Recognition Arrangement (MRA)
for Good Manufacturing Practice (GMP).
the accessibility of the medicine,
which can solve
the public health’s
problem
8/12/2010 26

27. THANK YOU FOR YOUR
ATTENTION
THANK YOU FOR YOUR
ATTENTION
www.fda.moph.go.th
E-mail: be.study@gmail.com
8/12/2010 27

28. Asian Food Regulation Information Service is a resource for the
food industry. We have the largest database of Asian food
regulations in the world – and it’s FREE to use.
We publish a range of communication services (free and paid), list
a very large number of food events and online educational
webinars and continue to grow our Digital Library.
Feel free to contact us anytime to talk about your specific
requirements, offer comments, complaints or to compliment us.
We look forward to hearing from you soon!
www.asianfoodreg.com
adrienna@asianfoodreg.com