Clinical Trial Supply East Asia

transcript

FOCUSED. TRUSTED. GLOBAL.

Clinical Trial Supply East Asia2015

Mainfong AngDirector, Clinical Operations

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…

What we needSupply deliveredo To the right placeo At the right timeo At the right quantity

Supply processes regulations

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

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

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

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

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.

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)

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)

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

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.

Specific regulation in Hong KongAdditional RA submission for IPo Clinical trial certificate

Each import license is valid for six months only

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

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”

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.

Better integration to support compliance

Start up: o Communication Plan, Roles & Responsibilities

• Sponsor• Manufacturer of IP / Various Supplies

Vendor• CRO / Project Management Team• CRO / Regulatory Submission Team• Site Personnel

CommunicationCommunication between the global and regional teamo Frequento Completeo Accurateo Timely

Roles & Responsibilitieso Improve overall understanding of

responsibilities within each roleo 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

Ensure compliance through training

o Understand the regulationso Adequate training and guidance o Change control

Ref: Chatfield Safety Training and Advisory UK PSC_Biotech

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)

Real life situations

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.

Shipment held up…Supplies were held up in Philippines

Additional fee is required even though the invoice was marked “DDP”

Custom clearance FAILED…

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

Shipment pick-up failure

During MERS…

Letter of Authority

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

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

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.

Reminders…

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

Country idiosyncrasies

o Communicationo Holidayso Religions

Supply management

o Accurate supply forecastso Tracking of the number of kits imported o Tracking supply levels at the sites

Weather changes

Best Practice

o Work with local experts, CRO with extensive local experience….

Clinical Trial Supply East Asia

Health & Medicine