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Introduction to Taiwan’s Guidelines for Implementing Decentralized Elements in Medicinal Product Clinical Trials

Introduction to Taiwan’s Guidelines for Implementing Decentralized Elements in Medicinal Product Clinical Trials

2023/12/15

The development of digital tools such as the internet, apps, and wearable devices have meant major breakthroughs for clinical trials. These advances have the potential to reduce the frequency of trial subject visits, accelerate research timelines, and lower the costs of drug development. The COVID-19 pandemic has further accelerated the use of digital tools, prompting many countries to adopt decentralized measures that enable trial subjects to participate in clinical trials regardless of their physical location. In step with the transition into the post-pandemic era, the Taiwan Food and Drug Administration (TFDA) issued the Guidelines for Implementing Decentralized Elements in Medicinal Product Clinical Trials in June, 2023[1]. The Guidelines are intended to cover a wide array of decentralized measures; they aim to increase trial subjects’ willingness to participate in trials, reduce the need for in-person visits to clinical trial sites, enhance real-time data acquisition during trials, and enable clinic sponsors and contract research organizations to process data remotely.

I. Key Points of Taiwan’s Guidelines for Implementing Decentralized Elements in Medicinal Product Clinical Trials

The Guidelines cover primarily the following matters: General considerations for implementing decentralized measures; trial subject recruitment and electronic informed consent; delivery and provision of investigational medicinal products; remote monitoring of trial subject safety; trial subject reporting of adverse events; remote data monitoring; and information systems and electronic data collection/processing/storage.

1. General Considerations for Implementing Decentralized Measures

(1) During clinical trial execution, a reduction in trial subject in-person visits may present challenges to medical observation. It is recommended that home visits for any given trial subject be conducted by the principal investigator, sub-investigator, or a single, consistent delegated study nurse.
(2) Sponsors must carefully evaluate all of the trial design’s decentralization measures to ensure data integrity.
(3) Sponsors must conduct risk assessments for each individual trial, and must confirm the rationality of choosing decentralized measures. These decentralized measures must also be incorporated into the protocol.
(4) When electronically collecting data, sponsors must ensure information system reliability and data security. Artificial intelligence may be considered for use in decentralized clinical trials; sponsors must carefully evaluate such systems, especially when they touch on determinations for critical data or strategies.
(5) As the design of decentralized clinical trials is to ensure equal access to healthcare services, it must provide patients with a variety of ways to participate in clinical trials.
(6) When implementing any decentralized measures, it is essential to ensure that the principal investigator and sponsor adhere to the Regulations for Good Clinical Practice and bear their respective responsibilities for the trial.
(7) The use of decentralized measures must be stated in the regulatory application, and the Checklist of Decentralized Elements in Medicinal Product Clinical Trials must be included in the submission.

2. Subject Recruitment and Electronic Informed Consent

(1) Trial subject recruitment through social media or established databases may only be implemented after the Institutional Review Board reviews and approves of the recruitment methods and content.
(2) Must comply with the Principles for Recruiting Clinical Trial Subjects in medicinal product trials, the Personal Data Protection Act, and other regulations.
(3) Regarding clinical trial subject informed consent done through digital software or devices, if it complies with Article 4, Paragraph 2 of the Electronic Signatures Act, that is, if the content can be displayed in its entirety and continues to be accessible for subsequent reference, then so long as the trial subject agrees to do so, the signature may be done via a tablet or other electronic device. The storage of signed electronic Informed Consent Forms (eICF) must align with the aforementioned Principles and meet the competent authority’s access requirements.

3. Delivery and Provision of Investigational Medicinal Products

(1) The method of delivering and providing investigational medicinal products and whether trial subjects can use them on their own at home depends to a high degree on the investigational medicinal product’s administration route and safety profile.
(2) When investigational medicinal products are delivered and provided through decentralized measures to trial subjects, this must be documented in the protocol. The process of delivering and providing said products must also be clearly stated in the informed consent form; only after being explained to a trial subject by the trial team, and after the trial subject’s consent is obtained, may such decentralized measures be used.
(3) Investigational products prescribed by the principal investigator/sub-investigator must be reviewed by a delegated pharmacist to confirm that the investigational products’ specific items, dosage, duration, total quantity, and labeling align with the trial design. The pharmacist must also review each trial subject’s medication history, to ensure there are no medication-related issues; only then, and only in a manner that ensures the investigational product’s quality and the subject’s privacy, may delegated and specifically-trained trial personnel provide the investigational product to the subject.
(4) Compliance with relevant regulations such as the Pharmaceutical Affairs Act, Pharmacists Act, Regulations on Good Practices for Drug Dispensation, and Regulations for Good Clinical Practice is required.

4. Remote Monitoring of Subject Safety

(1) Decentralized trial designs involve trial subjects performing relatively large numbers of trial-related procedures at home. The principal investigator must delegate trained, qualified personnel to perform tasks such as collecting blood samples, administering investigational products, conducting safety monitoring, doing adverse event tracking, etc.
(2) If trial subjects receive protocol-prescribed testing at nearby medical facilities or laboratories rather than at the original trial site, these locations must be authorized by the trial sponsor and must have relevant laboratory certification; only then may they collect or analyze samples. Such locations must provide detailed records to the principal investigator, to be archived in the trial master file.
(3) The trial protocol and schedule must clearly specify which visits must be conducted at the trial site; which can be conducted via phone calls, video calls, or home visits; which tests must be performed at nearby laboratories; and whether trial subjects have multiple or single options at each visit.

5. Subject Reporting of Adverse Events

(1) If the trial uses a digital platform to enhance adverse event reporting, trial subjects must be able to report adverse events through the digital platform, such as via a mobile phone app; that is, the principal investigator must be able to immediately access such adverse event information.
(2) The principal investigator must handle such reports using risk-based assessment methods. The principal investigator must validate the adverse event reporting platform’s effectiveness, and must develop procedures to identify potential duplicate reports.

6. Remote Data Monitoring

(1) If a sponsor chooses to implement remote monitoring, it must perform a reasonability assessment to confirm the appropriateness of such monitoring and establish a remote monitoring plan.
(2) The monitoring plan must include monitoring strategies, monitoring personnel responsibilities, monitoring methods, rationale for such implementation, and critical data and processes that must be monitored. It must also generate comprehensive monitoring reports for audit purposes.
(3) The sponsor is responsible for ensuring the implementation of remote monitoring, and must conduct risk assessments regarding the implementation process’ data protection and information confidentiality.

7. Information Systems and Electronic Data Collection, Processing, and Storage

(1) In accordance with the Regulations for Good Clinical Practice, data recorded in clinical trials must be trustworthy, reliable, and verifiable.
(2) It must be ensured that all organizations participating in the clinical trial have a full picture of the data flow. It is recommended that the trial protocol and trial-related documents include data flow diagrams and additional explanations.
(3) Define the types and scopes of subject personal data that will be collected, and ensure that every step in the process properly protects their data in accordance with the Personal Data Protection Act.

II. A Comparison with Decentralized Trial Regulations in Other Countries

Denmark became the first country in the world to release regulatory measures on decentralized trials, issuing the “Danish Medicines Agency’s Guidance on the Implementation of Decentralized Elements in Clinical Trials with Medicinal Products” in September 2021[2]. In December 2022, the European Union as a whole released its “Recommendation Paper on Decentralized Elements in Clinical Trials”[3]. The United States issued the draft “Decentralized Clinical Trials for Drugs, Biological Products, and Devices” document in May 2023[4]. The comparison in Table 1 shows that Taiwan’s guidelines a relatively similar in structure to those of Denmark and the EU; the US guidelines also cover medical device clinical trials.

Table 1: Summary of Decentralized Clinical Trial Guidelines in Taiwan, Denmark, the European Union as a whole, and the United States

 

Taiwan

Denmark

European Union as a whole

United States

What do the guidelines apply to?

Medicinal products

Medicinal products

Medicinal products

Medicinal products and medical devices

Trial subject recruitment and electronic informed consent

Covers informed consent process; informed consent interview; digital information sheet; trial subject consent form signing; etc.

Covers informed consent process; informed consent interview; trial subject consent form signing; etc.

Covers informed consent process; informed consent interview; digital information sheet; trial subject consent form signing; etc.

Covers informed consent process; informed consent interview; etc.

Delivery and provision of investigational medicinal products

Delegated, specifically-trained trial personnel deliver and provide investigational medicinal products.

The investigator or delegated personnel deliver and provide investigational medicinal products.

The investigator, delegated personnel, or a third-party, Good Distribution Practice-compliant logistics provider deliver and provide investigational medicinal products.

The principal investigator, delegated personnel, or a distributor deliver and provide investigational products.

Remote monitoring of trial subject safety

Trial subjects may do return visits at trial sites, via phone calls, via video calls, or via home visits, and may undergo testing at nearby laboratories.

Trial subjects may do return visits at trial sites, via phone calls, via video calls, or via home visits, and may undergo testing at nearby laboratories.

Trial subjects may do return visits at trial sites, via phone calls, via video calls, or via home visits.

Trial subjects may do return visits at trial sites, via phone calls, via video calls, or via home visits, and may undergo testing at nearby laboratories.

Trial subject reporting of adverse events

Trial subjects may self-report adverse events through a digital platform.

Trial subjects may self-report adverse events through a digital platform.

Trial subjects may self-report adverse events through a digital platform.

Trial subjects may self-report adverse events through a digital platform.

Remote data monitoring

The sponsor may conduct remote data monitoring.

The sponsor may conduct remote data monitoring.

The sponsor may conduct remote data monitoring (not permitted in some countries).

The sponsor may conduct remote data monitoring.

Information systems and electronic data collection, processing, and storage

The recorded data must be credible, reliable, and verifiable.

Requires an information system that is validated, secure, and user-friendly.

The recorded data must be credible, reliable, and verifiable.

Must ensure data reliability, security, privacy, and confidentiality.

 

III. Conclusion

The implementation of decentralized clinical trials must be approached with careful assessment of risks and rationality, with trial subject safety, rights, and well-being as top priorities. Since Taiwan’s Guidelines for Implementing Decentralized Elements in Medicinal Product Clinical Trials were just announced in June of this year, the status of decentralized clinical trial implementation is still pending industry feedback to confirm feasibility. The overall goal is to enhance and optimize the clinical trial environment in Taiwan.

 

Reference:

[1] 衛生福利部食品藥物管理署，〈藥品臨床試驗執行分散式措施指引〉，2023/6/12，https://www.fda.gov.tw/TC/siteListContent.aspx?sid=9354&id=43548（最後瀏覽日：2023/11/2）。

[2] [DMA] DANISH MEDICINES AGENCY, The Danish Medicines Agency’s guidance on the Implementation of decentralised elements in clinical trials with medicinal products (2021), https://laegemiddelstyrelsen.dk/en/news/2021/guidance-on-the-implementation-of-decentralised-elements-in-clinical-trials-with-medicinal-products-is-now-available/ (last visited Nov. 2, 2023).

[3] [HMA] HEADS OF MEDICINES AGENCIES, [EC] EUROPEAN COMMISSION & [EMA] EUROPEAN MEDICINES AGENCY, Recommendation paper on decentralised elements in clinical trials (2022), https://health.ec.europa.eu/latest-updates/recommendation-paper-decentralised-elements-clinical-trials-2022-12-14_en (last visited Nov. 2, 2023).

[4] [US FDA] US FOOD AND DRUG ADMINISTRATION, Decentralized Clinical Trials for Drugs, Biological Products, and Devices (draft, 2023), https://www.fda.gov/regulatory-information/search-fda-guidance-documents/decentralized-clinical-trials-drugs-biological-products-and-devices (last visited Nov. 2, 2023).

※Introduction to Taiwan’s Guidelines for Implementing Decentralized Elements in Medicinal Product Clinical Trials,STLI, https://stli.iii.org.tw/en/article-detail.aspx?d=9100&i=168&no=55&tp=2 (Date:2025/07/02)
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Lu, Cheng-Yen
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Release： 2023/12
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To gain the international competitiveness, the government will continue to promote policies and measures. By establishing the free economic demonstration zone, it is expected to create innovative effects into the education system and to create more job opportunities.2.Legislation Yuan has reviewd “The Free Ecomonic Pilot Zones Special Act”The Republic of China (R.O.C) have been carried out “free economic” recent years, by promoting “Free Economic Pilot Zone” (hereinafter as FEPZs) to encourage every industrial and foreign investment. Besides, FEPZs will not only keep talents and technologies in R.O.C but also liberalize and internationalize our economic.The Executive Yuan had approved a Bill titled “The Free Economic Pilot Zones Special Act” (hereinafter as the Bill) on Dec. 26th, 2013. At the end of May, the Joint Economic, Internal Administration, and Finance Committee of the Legislation Yuan (the Congress) have taken five public hearings for the Bill, and amended the Bill according to the advices proposed by specialists. Not until the deliberation of the Bill item by item and its passage in the Congress, the second stage of the FEDZ program would not be initiated. There are five main points, including the treatments on foreigners, tax incentives for R.O.C businessman, foreign professionals and foreign companies, regulations on untaxed goods and labor, regulations on industrial development, such as the agriculture and the medical service, and certain new items on education and professional services.The government considers that there have to be enough human resource to sustain the opened industries, so Executive Yuan is trying to promote innovative education in FEPZs. The core concept of FEPZs is foresight, liberalization and internationalization, the premier said, and the higher education systems belong to high-end service and have much more marketability and variability compared to other education systems. Through innovative and efficient way to manage the school could let University being much more liberalized. Furthermore, the higher education systems in R.O.C. have to connect with international education to avoid being marginalized. Our first stage of education innovation will promote to set up “degree programs” and “professional courses”. The first phase for the Ministry of Education is going to found “degree programs” or “professional courses” through collaboration way. The Ministry of Education will also draw up related regulations or guidance on standards for school cooperation, co-regulation, setup conditions, supervision, enrolling new student, and recruiting staff.? Once the Bills pass, The Ministry of Education plans to establish “branch school” and “independence campus” helping R.O.C. higher education goes internationalized.On the other hand, Our medical service also has strong international competitiveness. R.O.C is engage in developing international medical and health industry. The premier said, the Ministry of Health and Welfare have proposed some measures, such as limitation to the number of medical centre, medical personnel working hours, and NHI is not allow to use in the zones.The premier added, on the extemporaneous sittings, “The Free Economic Pilot Zones Special Act” will be the priority bills and be deliberated in the end of June By establishing the free economic demonstration zone, it is expected to propel R.O.C take part in Trans-Pacific Partnership (TPP) and the Regional Comprehensive Economic Partnership (RCEP).3.Executive Yuan’s rapid roll-out of “The Free Economic Pilot Zones”, and has published a report concerning the legal and economic implications of its the BillThe “Free Economic Pilot Zones” (hereinafter as FEPZs) plays a pivotal role in promoting market liberalization, especially at an international level. Premier of the Executive Yuan, Mr. Jiang Yi-Hua has stated that the “market economy” and “innovation economy” allows for tremendous economic prosperity to be embraced by the Republic of China (hereinafter as R.O.C). The seizing of such opportunity has been the goal of government efforts, which can be attested by the recent proposal of the “The Free Economic Pilot Zones Special Act” (hereinafter as the Bill), currently undergoing review and consultation proceedings. The Premier further stressed that the national economy should not be left excluded from international commerce, on the other hand, it is imperative that closer economic bonds with other nations are forged, therefore allowing itself open up to wider scope of opportunities for growth. The key in rendering this possible is through the enactment of laws. At a time, when Trans-Pacific nations, including the United States of America, Japan and countries from Southeast Asia, are working towards regional economic cooperation, if R.O.C. is to be left out, it is feared that its position in the global market would further be marginalized.The core innovative strengths of the FEPZs include “Smart Logistics”, “International healthcare services”, “Value added agriculture”, “Financial Services”, “Education Innovation”, all of which are implemented by employing R.O.C.’s finest workforce, knowledge, information and communications technology (ICT), geographical position and cross-strait relationship advantages, leading way for an advantageous basis for pioneering economic development. The first stage of development will be based on 6 locations proximal to the sea (including Keelung Port, Taipei Port, Kaohsiung Port, Suao Harbor, Anping Port, Taichung Port) and Taoyuan Aerotropolis and Pingtung Agricultural Biotech Park. The second stage of development would only commence after the Bill have been approved by the legislative Yuan, which would attract much capital investment, hence boosting high employment rates. Presently, besides the aforementioned regions opened up for the FEPZs, other cities and industrial sites (including those from offshore islands), are striving to gain membership of the FEPZs, or applying for empirical research of the FEPZs.The Executive Yuan has published a report concerning the legal and economic implications of its the Bill on May 2014. The report largely consists of assessments made by varying governing bodies, such as Ministry of Home Affairs, Financial Supervisory Commission etc., on the implications of the draft concerning real estate, employment, fiscal income, logistics, conditions for medical care, agriculture, higher education, social environment and social wealth redistribution etc.Furthermore, international attention has been closely centered on the progress of FEPZs. During the “The third review of the trade policies and practices of Chinese Taipei” after R.O.C accession to the World Trade Organization (WTO) held on the 17th of September 2014 in Geneva, each member state has demonstrated expectations arising out of the direction and planning undertaken for the FEPZs. National economic and international commercial reforms are under way and have seen much progress in further promoting the overall strength of the economic system, in an effort to respond to the rapid global political and economic developments, for example, through the signing of Economic Cooperation Framework Agreement (ECFA), and the implementation of FEPZs policies. In the future, it will be expected that R.O.C. will strive for a more integral international commercial system, allowing much capital investment inflows as well as the cultivating of high-caliber human resources.To promote more liberal and internationalized development of Taiwan economy, government of Republic of China (R.O.C) approved the “Free Economic Pilot Zone (FEPZ) Plan,” which the Bill is currently censored in Legislation Yuan and the measures would be implemented in two phases. The first phase of FEPZs would be initiated within six free trade ports, Taoyuan airport free trade zone, and Pingtung Agricultural Biotechnology Park; other industries that match up with the idea of liberalization, internationalization and foresight can all be incorporated into FEPZ through continuing examination under Execution Yuan. After this special legislation is passed, the set-ups of demonstration zones can be applied by authorities either of central or of local government and the related promotion works of the second phase will be unfolded immediately.Heading to the target of becoming Kin-Xiao (Kinmen and Xiaomen) Free Trade Zone, Kinmen government planned to apply to be one of the FEPZs and thus cooperated with Taiwan Institute of Economic Research (TIER) on December 11, for a commissioned research (which was later released on the conference of accelerating Kin-Xia FTZ on December 19) on evaluating if Kinmen is qualified for an application of FEPZs. Kinmen’s critical location and the featured industries have composed a perfect environment complying with the ideas such as value-added agriculture, international healthcare and innovative education for FEPZ. For instance, the white liquor industry in Kinmen represents the international management and promotion of agricultural products, and is the best example for value-added agriculture. “Long-term Healthcare Village in Kinmen,” which is currently developing in Kinmen, would also be a drive for international healthcare industry. Based on the Taiwan-featured culture, “International Education City” could be developed with a liberal and innovative atmosphere, which would attract famous schools in world to set up their branch school in Kinmen. Above all, Kinmen County vice Mayor, Wu Yo-Chin, indicated that Kinmen would be the first choice for FEPZ and would hold the key to open a new gate for the Cross-Strait. The vice Mayor emphasized that Kinmen government has well budgeting and financial management, which needn’t the extra aids from central government, yet Kinmen was excluded in the first phase of FEPZs. Although Kinmen would apply to be a FEPZ in the second phase after the special legislation passed, Kinmen still strived for taking part in the first phase of FEPZs due to the uncertain schedule for implementation of regulations on FEPZs.National Development Council (NDC), however, gave an opinion on issue of Kinmen applying to be in the first phase of FEPZs, which declared again the original plan for the first phase only included six free trade ports, Taoyuan airport free trade zone, and Pingtung Agricultural Biotechnology Park. NDC also suggested Kinmen could still follow after the first phase and apply to be a FEPZ in the second phase.

 After the European Union's Artificial Intelligence Law, the draft of AI Basic Law is announced in Taiwan.

After the European Union's Artificial Intelligence Law, the draft of AI Basic Law is announced in Taiwan. 2024/09/19 Countries around the world are currently seeking to establish AI governance principles. The U.S. currently has only AI executive orders and state bills, and the European Union (EU) first AI law came into effect in August 2024. Taiwan has announced a draft of AI Basic Law for public comments on July 15, 2024, which, if passed by the Legislative Yuan, will become the world's second special legislation on AI. Taiwan's Coming AI Basic Law - Legislative Development and Progress With the successful conclusion of the 2024 Paris Olympics, AI technology has demonstrated its potential on the global stage, bringing new experiences to the public in varied areas, such as sport competition analysis, athlete training, and referee assisting, and showing that AI has also crossed over into the sports industry, in addition to its known applications in areas such as healthcare, finance, transportation, arts and culture fields. As AI will be apply in various industries, it may also bring new risks or impacts to individuals or society. Countries are seeking to establish guidelines and principles for AI governance. The EU’s Artificial Intelligence Act, which was announced to take effect in August 2024. Even in the AI pioneer, the U.S., there are currently only U.S. President’s AI Executive Orders and bills introduced by Congress or state governments. When Taiwan President Lai announced the promotion of the Island of Artificial Intelligence, Taiwan also had a draft of the AI Basic Law announced for public comments by the National Science and Technology Council (NSTC) on July 15, 2024, proposing the principles of basic values for the development of AI in Taiwan. What is the Basic Law in Taiwan? There are 11 basic laws/acts in Taiwan, including the Fundamental Science and Technology Act, and the Ocean Basic Act, etc. A basic law/act is a legislative model of principle, progress, or guideline for a specific important matter. The AI Basic Law serves as a declaration of policy integration, reveals the government's goals and principles, and regulates the executive branch without directly regulating the people, or deriving the rights for substantive claims. Why Taiwan need a Basic Law on Artificial Intelligence? AI is evolving rapidly, and its applications are spreading to a wider range of areas. If all sectors and administrations have different values, there will be no way for a country to develop AI. NSTC has announced a total of 18 articles in the draft, in Article 3 first set out 7 common principles, such as human autonomy, from the AI research and development to the final market application must comply with the basic values; and in the following provisions of Article 4 to declare that the government's 4 major promotional focuses. The most important provision is found in Article 17, which requires that government ministries should review and adjust the functions, businesses and regulations under their scope in accordance with the Basic Law, so as to enable the executive branch to accelerate its response to the changes brought about by AI, and to share a common set of values: the promotion of innovation while taking human rights into consideration. 7 basic principles The draft AI Basic Law in the announcement contains the following 7 basic principles: 1. Sustainable development and well-being: Social equity and environmental sustainability should be taken into account. Appropriate education and training should be provided to minimize the possible digital gap, so that people can adapt to the changes brought about by AI. 2. Human autonomy: It shall support human autonomy, respect for fundamental human rights and cultural values such as the right to personal integrity, and allow for human oversight, thereby implementing a human-based approach that upholds the rule of law and democratic values. 3. Privacy Protection and Data Governance: The privacy of personal data should be properly protected to avoid the risk of data leakage, and the principle of data minimization should be adopted; at the same time, the opening and reuse of non-sensitive data should be promoted. 4. Security and safety: In the process of AI research and development and application, security measures should be established to prevent security threats and attacks and to ensure the robustness and safety of the system. 5. Transparency and explainability: The output of AI should be appropriately disclosed or labeled to facilitate the assessment of possible risks and the understanding of the impact on related rights and interests, thereby enhancing the trustworthiness of AI. 6. Fairness and non-discrimination: In the process of AI research and development and application, the risks of bias and discrimination in algorithms should be avoided as much as possible, and should not lead to discriminatory results for specific groups. 7. Accountability: Ensure the assumption of corresponding responsibilities, including internal governance responsibilities and external social responsibilities. 4 key areas of promotion 1. Innovative Collaboration and Talent Cultivation: Ensuring the resources and talent needed for AI. 2. Risk management and application responsibility: Risks must be identified and managed before AI systems can be safely applied. 3. Protection of rights and access to data: People's basic rights, such as privacy, cannot be compromised. 4. Regulatory Adaptation and Business Review: Policies and regulations must be agile to keep pace with AI development. The AI Basic Law is paving the way for Taiwan's future opportunities and challenges. AI development requires sufficient resources, data and a friendly environment; to ensure the safe application of AI, it is necessary to first identify and plan for different possible risks, and the draft AI Basic Law has initially drawn a blueprint for the above innovative development and safe application. In the future, various government ministries will need to work together to keep up with the wave of AI innovation in terms of business and legal regulations for multiple fields and industries. It is believed that Taiwan can leverage the advantages in the semiconductor industry and talent resources to gain a favorable global strategic position for the development of AI, as well as to help achieve the goal of "AI for good" to enhance the well-being of Taiwan people through a sound legal environment.

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