June 2024
Taiwan's Legislative Yuan Passed the Regenerative Medicine Dual Legislation
June 2024
Biotech and Pharmaceutical Law Team of Lee, Tsai & Partners [1]
On June 4, 2024, Taiwan's Legislative Yuan completed the third reading and passed the "Regenerative Medicine Act" and the "Regenerative Medicine Product Regulations" (hereinafter collectively referred to as the "Regenerative Medicine Dual Acts" [2] ), and the Regenerative Medicine Dual Acts have been promulgated by the President on June 19, 2024, officially establishing a regulatory framework for regenerative medicine technologies and pharmaceuticals at the legal level, outlining a blueprint for the development of Taiwan's regenerative medicine industry.
I. Key Points of the Regenerative Medicine Act
To ensure the safety, quality, and efficacy of regenerative medicine and to protect patient rights, the Regenerative Medicine Act regulates the scope of regenerative medicine practices by medical institutions and physician qualifications, the management of the sources of tissues and cells, supervision and prevention measures, advertisements for recruiting cell donors, and other related matters. The act aims to accelerate the application of regenerative medicine research results to clinical medicine. The key points of the Regenerative Medicine Act are as follows:
1. Definition of Regenerative Medicine: Regenerative medicine is defined as the use of genes, cells, and their derivatives to treat, repair, or replace human cells, tissues, and organs (Article 3).
2. Promotion and R&D of Regenerative Medicine: The central competent authority is required to formulate a plan for promoting regenerative medicine and establish a Regenerative Medicine Review Committee (Articles 4 and 5). The central competent authority or the central authority in charge of relevant industry may provide incentives or subsidies for the research and development of regenerative medicine (Article 10).
3. Exemption from Clinical Trials: In principle, medical institutions must conduct and complete clinical trials before implementing regenerative medicine technologies (Article 7). However, exemptions from completing clinical trials are allowed under the following circumstances (Article 8):
(1) For treating life-threatening or severely disabling diseases for which there are no suitable drugs, medical devices, or medical technologies available domestically (commonly referred to as "compassionate use"), but the treatment must exclude xenogeneic cells and tissues.
(2) For regenerative technologies approved by the central competent authority before the implementation of the Regenerative Medicine Act.
4. Regulation governing Embryos and Embryonic Stem Cells: The Regenerative Medicine Act prohibits certain practices involving embryos or embryonic stem cells in regenerative medicine research, including the creation of embryos through artificial fertilization and the creation of hybrids (Article 9).
5. Implementation of Regenerative Medicine Technologies: Medical institutions may undertake or commission regenerative biotechnology companies or other medical institutions for necessary cell culture, processing, and preservation (collectively referred to as "Cell Operations"). These institutions or commissioned entities are exempt from obtaining a pharmaceutical manufacturing license under the Pharmaceutical Affairs Act but their Cell Operations must undergo inspection and approval by the central competent authority (Article 14).
6. Management of Regenerative Medicine Tissues and Cells: The establishment of regenerative medicine cell banks requires approval from the central competent authority (Article 18). The Regenerative Medicine Act also regulates the qualifications of donors of regenerative medicine tissues and cells, written consent, and informed consent requirements (Articles 19 and 20).
7. Supervision, Remedies, and Penalties: The Regenerative Medicine Act regulates advertisements for regenerative medicine and the recruitment of tissue and cell donors. If a medical institution affects patient rights and safety, the central competent authority may order the suspension or termination of all or part of the regenerative medicine practices and announce it publicly. Penalties for violations of the Regenerative Medicine Act, such as non-medical institutions performing regenerative medicine or advertising for regenerative medicine, can be as high as NT$20 million (Articles 21 to 23, 26, and 28).
II. Key Points of the Regenerative Medicine Product Regulations
To ensure the safety, quality, and efficacy of regenerative medicine products and to protect patient rights, the Regenerative Medicine Product Regulations covers the inspection and registration of regenerative medicine products, conditional approvals, manufacturing and sales regulations, suitability assessments of tissue and cell donors, informed consent and recruitment advertisements, patient rights to advanced treatments, and strengthened post-market tracking and management. The key points of the Regenerative Medicine Product Regulations are as follows:
1. Special Law under the Pharmaceutical Affairs Act: The Regenerative Medicine Product Regulations is a special law to the Pharmaceutical Affairs Act, and regenerative medicine products are considered drugs under Article 6 of the Pharmaceutical Affairs Act (Articles 1 and 3).
2. Definition and Classification of Regenerative Medicine Product: Regenerative medicine products are defined as products containing genes, cells, and their derivatives for human use. They are classified into four categories: gene therapy products, cell therapy products, tissue-engineered products, and composite products (Articles 3 and 4).
3. Manufacturers Supervision: Manufacturers of regenerative medicine products must have a full-time pharmacist supervising production and employ full-time staff with relevant academic backgrounds and specialized knowledge (Article 5).
4. Pre-market Inspection and Registration: Before launching into the market, regenerative medicine products must undergo inspection and registration to obtain a drug permit license or conditional approval for manufacturing or import (Article 6).
5. Conditional Approval System:
(1) For life-threatening or severely disabling diseases, conditional approval for up to five years may be granted after completing Phase II clinical trials, demonstrating safety and preliminary efficacy. Extension of the approval is not permitted (Article 9).
(2) The central competent authority must seek the approval of the Regenerative Medicine Review Committee before granting conditional approval (Article 6).
(3) Conditions for approval include requirements for the pharmaceutical firms to complete efficacy verification tests, submit test reports regularly or within a specified period, propose fee structures and payment methods for the products, and provide remedies for patients experiencing adverse reactions leading to death, disability, or serious illness, and other conditions specified by the central competent authority may also apply to protect patient rights (Article 10).
6. Management of Tissue and Cell Sources: The Regenerative Medicine Product Regulations cover the suitability assessments of tissue and cell donors, written consent, and informed consent requirements for regenerative medicine products (Articles 11 to 13).
7. Management and Remedies of Regenerative Medicine Products: Advertisements for recruiting tissue and cell donors for regenerative medicine products are subject to advance approval. Advertisements for regenerative medicine products must comply with the Pharmaceutical Affairs Act on drug advertisements. Pharmaceutical firms planning to manufacture or distribute regenerative medicine products must obtain distribution and manufacturing license and adhere to Pharmaceutical Good Manufacturing Practice Regulations (i.e., GMP) and Western Pharmaceuticals Good Distribution Practice Regulations (i.e., GDP) for drugs. The Regenerative Medicine Product Regulations also covers safety monitoring and drug injury relief measures for regenerative medicine products (Articles 14 to 19).
8. Penalties: Violations of the Regenerative Medicine Product Regulations can result in fines of up to NT$2 million (Articles 20 and 21).
The effective date of the Regenerative Medicine Dual Acts will be determined and announced by the Executive Yuan. Additionally, over ten subsidiary regulations need to be formulated, including but not limited to the conditions and procedures for the designation and approval of regenerative products, the qualifications and approval procedures for medical institutions and their entrusted entities to perform Cell Operations, the contents required for informed consent forms, and the application procedures for the inspection and registration of regenerative medicine products and drug permits. Our firm welcomes the establishment and development of the regulatory framework for regenerative medicine and will continue to monitor related regulatory developments.
[1] The Biotech and Pharmaceutical Law Team consists of Taiwan-licensed attorneys, including Dr. Chung-Teh Lee, Teresa Huang, Oli Wong, Hannah Kuo, Sally Yang, and David Hung.
[2] For an introduction to the Executive Yuan's submission of the Regenerative Medicine Dual Acts to the Legislative Yuan in 2023, please refer to our article “ Overview of Key Biotech and Pharmaceutical Issues in Taiwan for 2023 ”
Biotech and Pharmaceutical Law Team of Lee, Tsai & Partners [1]
On June 4, 2024, Taiwan's Legislative Yuan completed the third reading and passed the "Regenerative Medicine Act" and the "Regenerative Medicine Product Regulations" (hereinafter collectively referred to as the "Regenerative Medicine Dual Acts" [2] ), and the Regenerative Medicine Dual Acts have been promulgated by the President on June 19, 2024, officially establishing a regulatory framework for regenerative medicine technologies and pharmaceuticals at the legal level, outlining a blueprint for the development of Taiwan's regenerative medicine industry.
I. Key Points of the Regenerative Medicine Act
To ensure the safety, quality, and efficacy of regenerative medicine and to protect patient rights, the Regenerative Medicine Act regulates the scope of regenerative medicine practices by medical institutions and physician qualifications, the management of the sources of tissues and cells, supervision and prevention measures, advertisements for recruiting cell donors, and other related matters. The act aims to accelerate the application of regenerative medicine research results to clinical medicine. The key points of the Regenerative Medicine Act are as follows:
1. Definition of Regenerative Medicine: Regenerative medicine is defined as the use of genes, cells, and their derivatives to treat, repair, or replace human cells, tissues, and organs (Article 3).
2. Promotion and R&D of Regenerative Medicine: The central competent authority is required to formulate a plan for promoting regenerative medicine and establish a Regenerative Medicine Review Committee (Articles 4 and 5). The central competent authority or the central authority in charge of relevant industry may provide incentives or subsidies for the research and development of regenerative medicine (Article 10).
3. Exemption from Clinical Trials: In principle, medical institutions must conduct and complete clinical trials before implementing regenerative medicine technologies (Article 7). However, exemptions from completing clinical trials are allowed under the following circumstances (Article 8):
(1) For treating life-threatening or severely disabling diseases for which there are no suitable drugs, medical devices, or medical technologies available domestically (commonly referred to as "compassionate use"), but the treatment must exclude xenogeneic cells and tissues.
(2) For regenerative technologies approved by the central competent authority before the implementation of the Regenerative Medicine Act.
4. Regulation governing Embryos and Embryonic Stem Cells: The Regenerative Medicine Act prohibits certain practices involving embryos or embryonic stem cells in regenerative medicine research, including the creation of embryos through artificial fertilization and the creation of hybrids (Article 9).
5. Implementation of Regenerative Medicine Technologies: Medical institutions may undertake or commission regenerative biotechnology companies or other medical institutions for necessary cell culture, processing, and preservation (collectively referred to as "Cell Operations"). These institutions or commissioned entities are exempt from obtaining a pharmaceutical manufacturing license under the Pharmaceutical Affairs Act but their Cell Operations must undergo inspection and approval by the central competent authority (Article 14).
6. Management of Regenerative Medicine Tissues and Cells: The establishment of regenerative medicine cell banks requires approval from the central competent authority (Article 18). The Regenerative Medicine Act also regulates the qualifications of donors of regenerative medicine tissues and cells, written consent, and informed consent requirements (Articles 19 and 20).
7. Supervision, Remedies, and Penalties: The Regenerative Medicine Act regulates advertisements for regenerative medicine and the recruitment of tissue and cell donors. If a medical institution affects patient rights and safety, the central competent authority may order the suspension or termination of all or part of the regenerative medicine practices and announce it publicly. Penalties for violations of the Regenerative Medicine Act, such as non-medical institutions performing regenerative medicine or advertising for regenerative medicine, can be as high as NT$20 million (Articles 21 to 23, 26, and 28).
II. Key Points of the Regenerative Medicine Product Regulations
To ensure the safety, quality, and efficacy of regenerative medicine products and to protect patient rights, the Regenerative Medicine Product Regulations covers the inspection and registration of regenerative medicine products, conditional approvals, manufacturing and sales regulations, suitability assessments of tissue and cell donors, informed consent and recruitment advertisements, patient rights to advanced treatments, and strengthened post-market tracking and management. The key points of the Regenerative Medicine Product Regulations are as follows:
1. Special Law under the Pharmaceutical Affairs Act: The Regenerative Medicine Product Regulations is a special law to the Pharmaceutical Affairs Act, and regenerative medicine products are considered drugs under Article 6 of the Pharmaceutical Affairs Act (Articles 1 and 3).
2. Definition and Classification of Regenerative Medicine Product: Regenerative medicine products are defined as products containing genes, cells, and their derivatives for human use. They are classified into four categories: gene therapy products, cell therapy products, tissue-engineered products, and composite products (Articles 3 and 4).
3. Manufacturers Supervision: Manufacturers of regenerative medicine products must have a full-time pharmacist supervising production and employ full-time staff with relevant academic backgrounds and specialized knowledge (Article 5).
4. Pre-market Inspection and Registration: Before launching into the market, regenerative medicine products must undergo inspection and registration to obtain a drug permit license or conditional approval for manufacturing or import (Article 6).
5. Conditional Approval System:
(1) For life-threatening or severely disabling diseases, conditional approval for up to five years may be granted after completing Phase II clinical trials, demonstrating safety and preliminary efficacy. Extension of the approval is not permitted (Article 9).
(2) The central competent authority must seek the approval of the Regenerative Medicine Review Committee before granting conditional approval (Article 6).
(3) Conditions for approval include requirements for the pharmaceutical firms to complete efficacy verification tests, submit test reports regularly or within a specified period, propose fee structures and payment methods for the products, and provide remedies for patients experiencing adverse reactions leading to death, disability, or serious illness, and other conditions specified by the central competent authority may also apply to protect patient rights (Article 10).
6. Management of Tissue and Cell Sources: The Regenerative Medicine Product Regulations cover the suitability assessments of tissue and cell donors, written consent, and informed consent requirements for regenerative medicine products (Articles 11 to 13).
7. Management and Remedies of Regenerative Medicine Products: Advertisements for recruiting tissue and cell donors for regenerative medicine products are subject to advance approval. Advertisements for regenerative medicine products must comply with the Pharmaceutical Affairs Act on drug advertisements. Pharmaceutical firms planning to manufacture or distribute regenerative medicine products must obtain distribution and manufacturing license and adhere to Pharmaceutical Good Manufacturing Practice Regulations (i.e., GMP) and Western Pharmaceuticals Good Distribution Practice Regulations (i.e., GDP) for drugs. The Regenerative Medicine Product Regulations also covers safety monitoring and drug injury relief measures for regenerative medicine products (Articles 14 to 19).
8. Penalties: Violations of the Regenerative Medicine Product Regulations can result in fines of up to NT$2 million (Articles 20 and 21).
The effective date of the Regenerative Medicine Dual Acts will be determined and announced by the Executive Yuan. Additionally, over ten subsidiary regulations need to be formulated, including but not limited to the conditions and procedures for the designation and approval of regenerative products, the qualifications and approval procedures for medical institutions and their entrusted entities to perform Cell Operations, the contents required for informed consent forms, and the application procedures for the inspection and registration of regenerative medicine products and drug permits. Our firm welcomes the establishment and development of the regulatory framework for regenerative medicine and will continue to monitor related regulatory developments.
[1] The Biotech and Pharmaceutical Law Team consists of Taiwan-licensed attorneys, including Dr. Chung-Teh Lee, Teresa Huang, Oli Wong, Hannah Kuo, Sally Yang, and David Hung.
[2] For an introduction to the Executive Yuan's submission of the Regenerative Medicine Dual Acts to the Legislative Yuan in 2023, please refer to our article “ Overview of Key Biotech and Pharmaceutical Issues in Taiwan for 2023 ”
