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 at least 3-hour educational programs per half day to justify an overnight CME program.
Programs, daily sign-in sheet of participants, documents/ invoices of expenses in relation to the event (such as hotel expenses, meeting expenses, speaker fee, and speaker contract/agreement) must be provided as evidences when there is a dispute.

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.

Mandatory Medical Components for Post-Marketing Studies:
‧ Protocol to address scientific objectives
　　- To have specific scientific interest
‧ Pre-determined sample size justification based on study description
　　- Should be based on clinical & statistical significant meaning
‧ Patient consent obtained
‧ IRB approval secured
‧ Follow GCP Guideline
　　- Minimum to comply with TW DOH GCP
‧ Registry on IRPMA website
‧ Payment must be appropriate and according to study design. It must not be set to influence prescribing behavior
　　- Must reflect time & efforts from investigators

Essential Components for Post-Marketing Surveillance:
‧ Protocol to address scientific objectives
　　- To have specific scientific interest
‧ Aim to collect individual patient’s efficacy and/or safety and/or QoL and/or outcome data
‧ Must be non-interventional and observational
　　- No interference on treatment decision
　　- Patient enrolment after treatment decision is made
‧ Pre-determined sample size justification based on study description
‧ Patient consent obtained
‧ IRB approval secured
‧ Follow GCP principle
‧ Registry on IRPMA website
‧ Payment must be appropriate and according to study design. It must not be set to influence prescribing behavior
　　- Must reflect time & efforts from investigators

Essential Components for Market Research:
‧ With scientific research methodology:
　　- Sampling techniques
　　- Data collection techniques
　　- Analysis techniques
‧ Samples size: usually relatively small, and representative
‧ Subjects (respondents) consent required
‧ Must not collect medical information (e.g. efficacy, effectiveness or safety data) which can be linked to identifiable
　individuals
　　- Individual data collection is prohibited
‧ If the subjects are patients, the research must be conducted by independent third party
‧ Must not be used as a tool for direct patient promotion
　　- Brand and/or compound name should not be mentioned
‧ Can only be used for research purposes; with one-way communication from subjects to the sponsors
　　- No communication from sponsor to individual subjects (patients/physicians)
　　- General report sharing allowed
‧ Must not be used to influence subjects’ view or behaviors
‧ Payment must be appropriate and according to study design. It must not be set to influence prescribing behavior.

Minimum Components for Patient Support Program
‧ Patients and physicians consent required
‧ Patient privacy must be protected
‧ Recommended to be conducted by a third party
‧ Must not be used as a tool for direct patient promotion

Format for PMS Registry System

*All items must be specified.