血液製劑條例

This Act is legislated to enhance the safety and quality of plasma derivatives and assure a stable supply thereof in order to protect public health. Matters not provided for under this Act shall be governed by the provisions of the Medical Care Act, the Pharmaceutical Affairs Act, and other relevant acts.

For the purposes of this Act, the term "competent authority" shall mean the Ministry of Health and Welfare at the central government level, the municipal governments at the municipal level, and the county/city governments at the county/city level.

The term “plasma derivative” refers to a pharmaceutical product of a certain dosage form prepared and processed from human plasma.

The materials for plasma derivatives shall be obtained from domestic blood donations. However, in the event that the domestic supply of such materials should become insufficient, plasma derivative manufacturers may, subject to the approval of the central competent authority, import the materials from foreign countries.

To achieve domestic self-sufficiency in plasma derivatives, the competent authority shall actively adopt educational and promotional measures to encourage local blood donation.

To ensure the safety, quality, and stable supply of plasma derivatives, as well as to promote research and local industrial development, the central competent authority shall promulgate development programs for plasma derivatives.

Blood donation institutions shall make efforts to promote blood donation, enhance the safety of the materials used for plasma derivatives, assist in ensuring a stable supply, and adopt measures to protect the health of blood donors.

Plasma derivative manufacturers shall meet the standards of Good Manufacturing Practices (GMP) and provide safe and high-quality plasma derivatives.

1Medical institutions and physicians shall give preference to the use of plasma derivatives made from blood donated domestically and provide patients with prescription information on such usage.

2To respect patients’ right to choose the preparations to be used, the use of preparations manufactured by other materials, methods or genetic engineering is not restricted by the preceding paragraph.

Blood donation institutions shall establish annual blood collection plans, which shall include blood donation volume, medical blood usage volume, plasma volume for manufacturing plasma derivatives, and the promotion of blood drive activities. The aforementioned plans shall be submitted to the central competent authority for further reference.

Plasma derivative manufacturers and importers shall periodically report their estimated and actual manufactured or imported quantity of plasma derivatives to the central competent authority for further reference.

1The central competent authority shall establish and announce annual plans regarding the estimated demand for plasma derivatives.

2The aforementioned plan shall include the following items:

31. Categories of plasma derivatives

42. Annual target volume for manufacturing and importing different categories of plasma derivatives

53. Volume of blood materials needed for said targeted volume of plasma derivatives

64. Quantity of interchangeable pharmaceutical products in lieu of plasma derivatives

75. Other matters related to the effective utilization of blood materials

1Blood donation institutions may engage in the manufacturing of plasma derivatives with the blood materials collected, or with the approval of the central competent authority, supply such blood materials to other plasma derivative manufacturers.

2Blood donation institutions may charge cost-based fees for the aforementioned supply to the plasma derivative manufacturers. The amount of said charge shall be submitted to and approved by the central competent authority.

1Blood donation institutions shall implement health screening on blood donors before collecting their blood.

2The standards for health requirements of blood donors and the items of the aforementioned health screening shall be prescribed by the central competent authority.

When necessary, blood donation institutions shall provide plasma derivative manufacturers with essential information, including blood collection date, test items and results, and donor information, so as to prevent the health hazards that may be caused by blood materials.

Violation of Articles 10 and 11 shall be subject to an administrative fine of no less than twenty thousand and no more than one hundred thousand New Taiwan Dollars, imposed by the central competent authority together with an order to take corrective action within a prescribed time. If the violation is not corrected within the prescribed time limit, consecutive fines may be imposed for each continuing violation.

Failure to pay the administrative fines imposed under this Act by the prescribed time shall result in compulsory enforcement [or injunctive relief] pursuant to the relevant laws.

The enforcement rules [of this Act] shall be promulgated by the central competent authority.

This Act shall take effect one year after the presidential announcement.