Approved on November 9, 2007
Effective on March 1, 2008
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The benchmarks of IRPMA Code is set referring to the Code
of Practices of European countries, United States, Japan,
and other neighboring countries, current local market common
rules, and the social expectation to the pharmaceutical industry.
This Implementing Regulations should be periodically reviewed
and revised by the COP committee of IRPMA (once half a year).
The revision will be adopted after being discussed and resolved
by the Board of Directors and Supervisors.
1. The marketing of OTC drugs is excluded, but OTC drugs used
under physician prescriptions or in hospitals are included.
2. The honorarium of the lecturer of symposia, congresses
and alike should be paid up to NT$10,000/hr.
Moderator / Chairperson: up to NT$10,000/specific venue
Panelist / Members of Focus Group: up to NT$10,000/event.
(International norms will be applied for international speakers).
3. In the case of sponsoring domestic or international symposia,
congresses or alike:
The travel reimbursement and registration fee should be exclusively
limited to the attendees, not to family members or accompanied
guests.
The flight tickets being sponsored should be up to business
class only.
There must be educational programs on the both days to justify
an overnight two-day CME program.
4. Gifts and items of medical utility:
(1) Cash: Payments in cash or cash equivalent (such as gift
certificate) must not be offered to healthcare professionals.
(2) Personal gifts: Gift for the personal benefit of healthcare
professionals (including, but not limited to music CDs, DVDs,
sporting or entertaining tickets, electronic items) must not
be provided or offered.
(3) Promotional Aids: Promotional aids or reminder items may
be provided or offered to healthcare professionals and appropriate
administrative staff, provided the gift is of minimal value
and relevant to the practice of the healthcare professional.
The value of the gift should not exceed NT$700. The names
of companies and / or products must be printed on the gifts.
(4) Items of Medical Utility: Medical journal or textbooks
for academic use for individual hospital departments or items
of medical utility may be offered or provided free of charge,
provided that such items are of modest value and are beneficial
to the provision of medical services and patient care.
(5) Cultural Courtesy Gifts: In accordance with local practices
and customs, gifts could be offered to healthcare professionals
on traditional festivals, which are defined and limited to
Chinese New Year and Moon Festival. However, the value of the gift should not exceed NT$1,800.
To follow local custom, flowers and funeral scrolls for funeral is allowable
when the deceased is healthcare professional. The amount should
not exceed NT$3,500.
5. Donation and educational grants must be clearly separated
from business. The intention of making a donation or providing
an educational grant must not be associated with influencing
purchasing, prescribing and pricing of medicines.
Donation and educational grants must not be given to personal
accounts or the accounts of individual departments of hospitals.
Donation or educational grants must only be given to the government
registered medical institutions, medical societies, associations
and foundations.
IRPMA strongly recommends each member company establishes
a proper review and approval process for Donation & Educational
Grant.
6. The expenses of hospitality should be limited to refreshments and/or meals incidental
to the main purpose of the Event and should not exceed NT$3,500 person/day.
For overseas events, the principle is that the amount should not exceed NT$3,500 person/day.
However, if the amount limits of the international/local regulations in the visiting
countries exceed NT$3,500 person/day, the regulations of the visiting can be followed.
7. All PMS shall go through JIRB, IRB or Ethics Committee;
In-vitro test and retrospective health economics studies are
not included and to be discussed in the future.
All human studies including PMS must be approved and managed
by Medical Director or equivalent CR Manager of member companies.
All PMS must be registered on the website of IRPMA PMS registry
system.
IRB approval code or approval date should be shown on study-related
documents.
Format for PMS Registry System
| Company Name |
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| Protocol Number |
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| Title of Study |
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| Primary Objective |
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| Number of Sites |
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| Period of StudyStarting date/Expected ending date |
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| Number of Patients |
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| IRB Approval Date |
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| Publication Plan/ Date |
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*All items must be specified.
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