Clinical Trial Supply East Asia

FOCUSED. TRUSTED. GLOBAL.
Clinical Trial Supply East Asia
2015
Mainfong Ang
Director, Clinical Operations

2
Agenda
o Supply processes regulations
o Better integration of regulatory groups to support
compliance with various regulations guiding clinical
shipments
o Successful and unsuccessful cases for managing
regulatory compliance across various trial aspects
o Reminders…

3
What we need
Supply delivered
o To the right place
o At the right time
o At the right quantity

4
Supply processes
regulations

5
Clinical trial supply regulation
Study drugs
• Item description
• Quantity
• Manufacturer
name & address
• Shipping port
• Shipper’s address
• Proforma Invoice
Lab kits
• Item description
• Quantity
• Manufacturer
name & address
• Shipping port
• Proforma invoice
Medical devices
• Product
description
• Quantity
• Catalog number
• Manufacturer
name & address
• Product
registration
certificate in the
country of origin
• Shipping port
• Sample of invoice

6
Clinical trial supply hurdles
Manufacturing
and Packaging
• GMP certificate
• Certificate of analysis
• Labeling
Approval
• Clinical Trial Submissions to various authorities
• Import Licenses /Permits
Final QC
• Courier
• Cold chain
• Temp taleDistribution
• Proforma invoices
• Tax / Duties terms
Sites
• Confirm receipt
• Trained/delegated personnel
• Proper storage to ensure stability of the supplies

7
Clinical trial supply regulation – General
o 22 – 30 weeks
o Parallel RA and EC submission for most EA
countries
o Import license requirement for drug, lab kits, medical
device is country-specific
o Local language required

8
Country specific regulation
Duration
(weeks)
Import License
for IP
Export
license
Local language
Singapore 22 – 26 Required Not required Malay, Simplified
Chinese, Tamil
South Korea 24 – 28 Required Not required Korean
Taiwan 24 – 28 Required Required Traditional Chinese
Hong Kong 24 – 30 Required Required Traditional Chinese
Thailand 26 - 30 Not required* MTA required Thai
Malaysia 22 - 26 CTIL Required Malay, Simplified
Chines, Tamil
Philippines 24 - 28 Required Required Tagalog, Cebuano,
Hiligaynon
* RA approval may serve as import licence
# Import permit is required for both IP and medical devices.

9
Country specific regulation - timeline
Import Permit
(IP, Lab kits,
devices)
Timeline (Approximate) Validity
Singapore ✓ IP (8 -12 weeks)
Lab kits/devices: 5 days
IP: 2 years
Lab kits/ devices: 1 year
South Korea ✓ IP (1week)
Lab kits/ devices: 3 weeks
1 year
Taiwan ✓ 4 weeks 2 years
Hong Kong ✓ 1 week 6 months
Thailand ✓ IP (6 – 8 weeks)
Lab kits/ devices: 2 weeks
IP: until total permitted quantity is
utilized
Lab kits/ devices: same expiry date
as the EC approval
Malaysia ✓ 8 weeks 3 years
Philippines ✓ 4 -6 weeks 1 year (single use)

10
Specific regulation in Singapore
Additional RA submission
o Clinical trial test material (Name, strength, quantity)
o Importer (company’s name & address, contact person &
details)
o GMP certificate or QP statement
o Certificate of Analysis
o Study drug label
o Packaging list/ Proforma invoice (except IP)
Import license is issued together with the
RA approval (CTC)

11
Specific regulation in South Korea
Additional RA submission for medical devices,
o Catalog number
o Images
o CE marking, CFG or product registration certificate in the
country of origin
Import permit can only be applied after
RA (MFDS) approval is obtained

12
Specific regulation in Taiwan
Additional RA submission for medical devices
o Certificate of Sales
Import license application for IP or medical device is
submitted together with the clinical trial application, but will
only be issued when the study is approved by RA (TFDA).
Import license will be issued in Traditional
Chinese.

13
Specific regulation in Hong Kong
Additional RA submission for IP
o Clinical trial certificate
Each import license is valid for six months only

14
Specific regulation in Thailand
o Certificate of free sale
o IMPD (quality control and drug manufacturing)
o ICF & Protocol synopsis(in Thai)
o Protocol (in Thai or English)
o GMP certificate
o Copy of EC approval
IP Import license has no expiry date*
Application forms are completed in Thai

15
Specific regulation in Malaysia
Additional RA submission in support of CTILapplication
o IMPD
o GMP certificate
o Certificate of analysis
o IMP label
o BSE/ TSE Porcine statement
o Proforma invoice
CTIL will only be released after EC approval
For lab kits and medical devices:
Comprehensive details
“Not for Resale, For Clinical Trial Use Only”

16
Specific regulation in Philippines
o RA (PFDA) approval
o Proforma Invoice
o Previous copy of import license
Import license can only be applied after RA approval.
Import licence is valid or single use and is
site-specific. It is recommended to use a
local depot.

17
Better integration to
support compliance

18
Start up:
o Communication Plan, Roles & Responsibilities
• Sponsor
• Manufacturer of IP / Various Supplies Vendor
• CRO / Project Management Team
• CRO / Regulatory Submission Team
• Site Personnel

19
Communication
Communication between the global and regional
team
o Frequent
o Complete
o Accurate
o Timely

20
Roles & Responsibilities
o Improve overall understanding of responsibilities
within each role
o Reduce timeline and errors!
Ref: Kallidus – developing talented people

o Point of contact for all
o Predict quantities of
clinical trial supplies
based on the protocol
design
o To maintain and track
information centrally
Project Manager is the KEY

22
Ensure compliance through training
o Understand the regulations
o Adequate training and guidance
o Change control
Ref: Chatfield Safety Training and Advisory UK
PSC_Biotech

23
Internal audit
o Assurance of compliance
o Perform periodic staff evaluation
o Early identification of any SOPs violation
o Recognize areas of potential improvement
Ref: Internal Audit training (kobridgeconsulting.com)

Real life situations

25
Delays in approval
GMP documents specific to United Kingdom were
inadvertently included with the local regulatory
submission in Hong Kong.
Lack of supporting documents, e.g. CE certificates.

26
Shipment held up…
Supplies were held up in Philippines
Additional fee is required even though the invoice was
marked “DDP”

Custom clearance FAILED…

29
Lab Kits held up…
You think you have all the required import license for
your lab kit ? (Maybe not for Australia and New Zealand)

30
Shipment pick-up failure
During MERS…
Letter of
Authority

31
Delegated staff?
PI or delegated staff?
o IP confirmation of receipt
o Drug administration
o Temperature log record
o Blinded vs Unblinded staff
Importance of having training documentation for delegated
staff like pharmacists and nurses.
More documentation required for study staff who
administers the study drug to patients

32
Unsuccessful cases of regulatory compliance
The batch number and expiry date were not indicated
in the IP shipment receipt.
Violation to Singapore GCP Section 4.6.3

33
Unsuccessful cases of regulatory compliance
IP inventory and accountability log did not fulfill the
regulatory requirement
Ensure template used is approved by the local
regulatory authority.

34
Reminders…

Know the requirement
o If you don’t have local office:
 Seek local regulatory experts’ advices
o If you do:
 Frequent communication with regulatory agency

Country idiosyncrasies
o Communication
o Holidays
o Religions

37
Supply management
o Accurate supply forecasts
o Tracking of the number of kits imported
o Tracking supply levels at the sites

Weather changes

39
Best Practice
o Work with local experts, CRO with extensive local
experience….

Q & A

Clinical Trial Supply East Asia

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