Yuan Rung Healthcare System New Drug Management Regulations

Revised on January 3, 2025

I. Purpose:

To ensure the safe and effective use of medications by patients in this hospital, to properly manage medication usage, and to avoid the waste of pharmaceutical resources.

II. Definition:

Any drug with a Ministry of Health and Welfare drug license that meets any of the following criteria:

1. Different from the existing drugs in this hospital in terms of ingredients, content, or dosage form.
2. Clinical therapeutic effect is superior to existing drugs, or has fewer adverse reactions than existing drugs, and is supported by literature.

III. Application Procedures:

1. Applicant: Limited to attending physicians of this hospital.
2. Application Time: To be submitted by the end of the first month of each quarter (before 1/31, 4/30, 7/31, 10/31).
3. Application Fee: After the application materials have been reviewed and confirmed by the Pharmacy Department, each case requires payment of a new drug application review fee of NT$15,000 to the counter (those who have paid for temporary procurement ratification cases are exempt from payment) , The receipt must be submitted to the Pharmacy Department for archiving. The hospital will begin the new drug review process upon receipt of the application. If the manufacturer or physician withdraws the application, or if the review cannot be completed due to incomplete submitted documents, no refund will be issued. Please consider carefully.
4. Required Documents (one copy):
   (1) New Drug Application Form (hard copy and electronic file). To be filled out by the applying physician.
   (2) New Drug Information Form (hard copy and electronic file). To be filled out by the manufacturer's representative. Example:New Drug Information Form Example
   (3) Chinese or English package insert.
   (4) Drug license, or relevant health authority certification from the country of origin of the drug.
   (5) Procurement proof from at least two medical centers in Taiwan.
   (6) At least one representative literature reference.
   (7) New drug Micromedex related data, BA/BE test report, and quality-related data for drug batches that passed BA/BE tests.
   (8) PIC/S GMP certification document.
   (9) Drug appearance photo file.
   (10) Original manufacturer's authorization letter (for applicants who are not the license holder).
   (11) Drug review fee receipt.

IV. Application Process

1. Submission: The applying physician or pharmaceutical company representative shall submit the required documents to the Pharmacy Department within the specified time. Late submissions will be considered as abandonment of the current application.
2. Pharmacy Department Preliminary Review: New drug application review, to be completed 15 days before the Pharmacy and Therapeutics Committee meeting.
3. Procurement Office Negotiation: After the preliminary review is completed, the Pharmacy Department will notify the manufacturer to proceed with price negotiation at the Procurement Office. After the negotiation process is completed, it will be transferred to the Pharmacy and Therapeutics Committee for review.
4. Pharmacy and Therapeutics Committee Review: New drug applications that pass the preliminary review will be submitted to the Pharmacy and Therapeutics Committee for review during the last week of March, June, September, and December each year. If the applying physician does not attend or does not delegate a representative to attend and explain, the application for that session will be considered forfeited.

V. Management Regulations

1. Pharmacy and Therapeutics Committee Resolutions Pharmacy and Therapeutics Committee Resolutions
   (1) Disapproved Cases: Similar drug products of the same type may not be resubmitted for discussion within one year.
   (2) Approved Cases: Starting from the date of internal announcement, the Procurement Office will be requested to notify the manufacturer to complete price negotiation within two weeks.
   The Pharmacy Department will complete the archiving, announcement, and shelving procedures. Applicants who fail to complete price negotiation will be considered to have abandoned the current application and may not resubmit the same drug application within one year.
2. Hospital drugs with no or fewer than no or fewer than 33 usage records in the past six months will be submitted to the Pharmacy and Therapeutics Committee for deletion.

VI. Post-Introduction Drug Evaluation:

1. Track the usage status of newly introduced drugs every six months.
2. Drugs decided by the Pharmacy and Therapeutics Committee to be deleted or those with poor supply from manufacturers may not be resubmitted for application within one year.

VII. Others:

In emergency situations such as drug recall requested by health authorities, or delays/shortages from manufacturers, etc., where normal supply cannot be provided and there are no similar ingredients available in the hospital, the Pharmacy Department will provide two to three manufacturers. After the Procurement Department obtains quotes, the Chief Committee Member will co-sign, and upon the President's approval, one will be selected and handled according to temporary drug procurement regulations.

VIII. Addendum:

This regulation shall be announced and implemented after approval by the Superintendent, and the same shall apply to any revisions.