Date post: | 12-Apr-2017 |
Category: |
Health & Medicine |
Upload: | medpace |
View: | 436 times |
Download: | 2 times |
FOCUSED. TRUSTED. GLOBAL.
Clinical Trial Supply East Asia2015
Mainfong AngDirector, Clinical Operations
FOCUSED. TRUSTED. GLOBAL.
2
FOCUSED. TRUSTED. GLOBAL.
3
Agendao Supply processes regulationso 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…
FOCUSED. TRUSTED. GLOBAL.
4
What we needSupply deliveredo To the right placeo At the right timeo At the right quantity
FOCUSED. TRUSTED. GLOBAL.
5
Supply processes regulations
FOCUSED. TRUSTED. GLOBAL.
6
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•Shipper’s address•Proforma invoice
Medical devices
•Product description•Quantity•Catalog number•Manufacturer name & address•Product registration certificate in the country of origin•Shipping port•Shipper’s address•Sample of invoice
FOCUSED. TRUSTED. GLOBAL.
7
Clinical trial supply hurdlesManufacturing and Packaging
•GMP certificate•Certificate of analysis•Labeling
Approval •Clinical Trial Submissions to various authorities•Import Licenses /Permits
Final QC•Courier •Cold chain •Temp tale
Distribution •Proforma invoices •Tax / Duties terms
Sites•Confirm receipt•Trained/delegated personnel•Proper storage to ensure stability of the supplies
FOCUSED. TRUSTED. GLOBAL.
8
Clinical trial supply regulation – General
o 22 – 30 weekso Parallel RA and EC submission for most EA
countrieso Import license requirement for drug, lab kits,
medical device is country-specifico Local language required
FOCUSED. TRUSTED. GLOBAL.
9
Country specific regulationDuration (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.
FOCUSED. TRUSTED. GLOBAL.
10
Country specific regulation - timelineImport Permit (IP, Lab kits, devices)
Timeline (Approximate)
Validity
Singapore ✓ IP (8 -12 weeks)Lab kits/devices: 5 days
IP: 2 yearsLab 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 utilizedLab kits/ devices: same expiry date as the EC approval
Malaysia ✓ 8 weeks 3 years
Philippines ✓ 4 -6 weeks 1 year (single use)
FOCUSED. TRUSTED. GLOBAL.
11
Specific regulation in SingaporeAdditional RA submissiono Clinical trial test material (Name, strength,
quantity)o Importer (company’s name & address, contact
person & details)o GMP certificate or QP statemento Certificate of Analysiso Study drug labelo Packaging list/ Proforma invoice (except IP)
Import license is issued together with the RA approval (CTC)
FOCUSED. TRUSTED. GLOBAL.
12
Specific regulation in South KoreaAdditional RA submission for medical devices,o Catalog number o Imageso CE marking, CFG or product registration
certificate in the country of origin
Import permit can only be applied afterRA (MFDS) approval is obtained
FOCUSED. TRUSTED. GLOBAL.
13
Specific regulation in TaiwanAdditional RA submission for medical deviceso 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 TraditionalChinese.
FOCUSED. TRUSTED. GLOBAL.
14
Specific regulation in Hong KongAdditional RA submission for IPo Clinical trial certificate
Each import license is valid for six months only
FOCUSED. TRUSTED. GLOBAL.
15
Specific regulation in ThailandAdditional RA submissiono Certificate of free saleo IMPD (quality control and drug manufacturing)o ICF & Protocol synopsis(in Thai)o Protocol (in Thai or English)o GMP certificateo Copy of EC approval
IP Import license has no expiry date*Application forms are completed in Thai
FOCUSED. TRUSTED. GLOBAL.
16
Specific regulation in MalaysiaAdditional RA submission in support of CTILapplication o IMPDo GMP certificateo Certificate of analysiso IMP labelo 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”
FOCUSED. TRUSTED. GLOBAL.
17
Specific regulation in PhilippinesAdditional RA submissiono RA (PFDA) approvalo Proforma Invoiceo Previous copy of import license
Import license can only be applied after RA approval.
Import licence is valid or single use and issite-specific. It is recommended to use a local depot.
FOCUSED. TRUSTED. GLOBAL.
18
Better integration to support compliance
FOCUSED. TRUSTED. GLOBAL.
19
Start up: o Communication Plan, Roles & Responsibilities
• Sponsor• Manufacturer of IP / Various Supplies
Vendor• CRO / Project Management Team• CRO / Regulatory Submission Team• Site Personnel
FOCUSED. TRUSTED. GLOBAL.
20
CommunicationCommunication between the global and regional teamo Frequento Completeo Accurateo Timely
FOCUSED. TRUSTED. GLOBAL.
21
Roles & Responsibilitieso Improve overall understanding of
responsibilities within each roleo Reduce timeline and errors!
Ref: Kallidus – developing talented people
FOCUSED. TRUSTED. GLOBAL.
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
FOCUSED. TRUSTED. GLOBAL.
23
Ensure compliance through training
o Understand the regulationso Adequate training and guidance o Change control
Ref: Chatfield Safety Training and Advisory UK PSC_Biotech
FOCUSED. TRUSTED. GLOBAL.
24
Internal audit
o Assurance of compliance o Perform periodic staff evaluationo Early identification of any SOPs violation o Recognize areas of potential improvement
Ref: Internal Audit training (kobridgeconsulting.com)
FOCUSED. TRUSTED. GLOBAL.
Real life situations
FOCUSED. TRUSTED. GLOBAL.
26
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.
FOCUSED. TRUSTED. GLOBAL.
27
Shipment held up…Supplies were held up in Philippines
Additional fee is required even though the invoice was marked “DDP”
FOCUSED. TRUSTED. GLOBAL.
28
FOCUSED. TRUSTED. GLOBAL.
Custom clearance FAILED…
FOCUSED. TRUSTED. GLOBAL.
30
Lab Kits held up…You think you have all the required import license for your lab kit ? (Maybe not for Australia and New Zealand)
FOCUSED. TRUSTED. GLOBAL.
31
Shipment pick-up failure
During MERS…
Letter of Authority
FOCUSED. TRUSTED. GLOBAL.
32
Delegated staff?PI or delegated staff?o IP confirmation of receipto Drug administrationo Temperature log recordo 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
FOCUSED. TRUSTED. GLOBAL.
33
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
FOCUSED. TRUSTED. GLOBAL.
34
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.
FOCUSED. TRUSTED. GLOBAL.
35
Reminders…
FOCUSED. TRUSTED. GLOBAL.
Know the requirementKnow the requirementKnow the requirementKnow the requirementKnow the requirement
o If you don’t have local office: Seek local regulatory experts’ advices
o If you do: Frequent communication with regulatory agency
FOCUSED. TRUSTED. GLOBAL.
Country idiosyncrasies
o Communicationo Holidayso Religions
FOCUSED. TRUSTED. GLOBAL.
38
Supply management
o Accurate supply forecastso Tracking of the number of kits imported o Tracking supply levels at the sites
FOCUSED. TRUSTED. GLOBAL.
Weather changes
FOCUSED. TRUSTED. GLOBAL.
40
Best Practice
o Work with local experts, CRO with extensive local experience….
CRO
FOCUSED. TRUSTED. GLOBAL.
41
FOCUSED. TRUSTED. GLOBAL.
Q & A