Yuan Rung Healthcare System New Drug Management Regulations

Revised on January 03, 2025

I. Purpose:

To ensure that patients in this hospital use safe and effective medications, to properly manage medication usage, and to avoid wasting pharmaceutical resources.

II. Definition:

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

1. Different from the ingredients, strength, or dosage form of existing medications in this hospital.
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 period: 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 documents are reviewed and confirmed by the Pharmacy Department, each case requires a new drug application review fee of NT$15,000 to the counter (those who have paid for temporary procurement ratification cases are exempt), and the receipt must be submitted to the Pharmacy Department for archiving. New drug review will commence upon receipt by this hospital. If the manufacturer or physician withdraws the application, or if the submitted documents are incomplete, resulting in an inability to complete the review, no refunds 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 Filling 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 certificates from at least two medical centers in Taiwan.
   (6) At least one representative literature reference.
   (7) New drug Micromedex related data, BA/BE trial certification report, and quality-related data for drug batches that passed BA/BE trials.
   (8) PIC/S GMP certification document.
   (9) Drug appearance photo file.
   (10) Original manufacturer's authorization letter (for applicants other than the license holder).
   (11) Drug review fee receipt.

IV. Application Process

1. Submission: The applying physician or manufacturer's representative shall submit the required documents to the Pharmacy Department within the stipulated 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 Department negotiation: Upon completion of the preliminary review, the Pharmacy Department will notify the manufacturer to proceed with price negotiation at the Procurement Department. After the negotiation process is completed, it will be forwarded 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 is absent or does not appoint a representative to attend and explain, the application will be considered forfeited for that session.

V. Management Regulations

1. Pharmacy and Therapeutics Committee Resolutions Pharmacy and Therapeutics Committee Resolutions
   (1) Disapproved cases: Similar drugs 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 Department 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. Those who fail to complete price negotiation will be considered to have abandoned the current application and may not resubmit an application for the same drug within one year.
2. Hospital medications with in the past six months no or fewer than in the past six months no or fewer than 33 usage records will be reported 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 that the Pharmacy and Therapeutics Committee decides to delete or those with poor supply from manufacturers may not be resubmitted for application within one year.

VII. Others:

In emergency situations such as drug recalls 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 case will be co-signed by the Chairman and, with the approval of the Superintendent, one will be selected and processed according to the temporary drug procurement regulations.

VIII. Addendum:

These procedures will be announced and implemented after approval by the Superintendent, and the same applies to any revisions.