台灣大學藥學專業學院

Activities

03/27/2023

The "International Conference on the Development and Regulatory Considerations for Complex Products" was held on March 25, 2023, by The Platform for Research and Inspiration in Regulatory Science. Experts and scholars from academia and industry were invited to discuss topics such as complex products, inhaled drug delivery, and lipid-based drug development. The first half of the conference covered regulatory considerations and challenges in developing complex drug-device combinations and inhaled therapies, as well as the evolution and impact of regulations and technologies in this field; the second half focused on lipid-based drug development, exploring the importance of lipid carriers in developing new vaccines and nucleic acid drugs. The conference aimed to promote academic exchange and understanding of current industry trends, providing valuable knowledge and recommendations for Taiwan's pharmaceutical industry.

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Conference brochure

國際藥政法規科學研究平台於2023年3月25日主辦「International Conference on the Development and Regulatory Considerations for Complex Products複雜產品開發及法規考量之國際研討會」。此次研討會邀請國內外產學界的專家學者，探討複雜產品及吸入劑型、脂質載體藥品開發等主題。上半場分享藥品-醫療器材複雜產品之法規及開發考量、開發乾粉吸入器學名藥所面對之挑戰，及吸入劑領域的科技及法規制度的演進和影響；下半場則以脂質載體及藥品開發為主題，探討脂質載體對新型疫苗、核酸藥品開發的重要性。希望能藉此活動增進國內外學術交流與了解目前產業發展趨勢，為臺灣醫藥產業提供有益的知識與建議。

活動海報
活動簡章

03/23/2023

On March 13, 2023, the Platform for Research and Inspiration in Regulatory Science hosted the "Keynote Speech of Lawyer Chia-Feng Lu (呂家鋒)". Lawyer Chia-Feng Lu, currently a shareholder at Greenberg Traurig Law Offices in Washington, DC & Tokyo, participated in two important bills that have greatly impacted the pharmaceutical industry: the Food and Drug Omnibus Reform Act (FDORA) and the Inflation Reduction Act (IRA). Lawyer Lu provided insights and highlighted the latest changes in US FDA policies. The US drug pricing reform will prompt stakeholders to adjust assets and strategies, changing drug markets. Attendance at the event will aid Taiwan's pharmaceutical industry in comprehending the practical impact of these bills on licensing, investment, and biotechnology. This knowledge will assist the industry in drug development and international market connections to tackle future challenges in the biopharmaceutical sector.

於2023年3月13日，國際藥政法規科學研究平台邀請呂家鋒律師進行專題演講。呂家鋒律師現為Greenberg Traurig律師事務所華盛頓特區與東京辦公室資深合夥人，在華府參與了兩項對製藥產業界影響重大法案：使用者付費法案(Food and Drug Omnibus Reform Act, FDORA)和降低通膨法案(Inflation Reduction Act, IRA)的協商。呂律師在本次專題演講分享了美國FDA法案背景與政策的最新變革，美國藥品定價制度的改革措施將重新定義產品商業上市的格局，促使利益相關者調整資產評估與企業策略，透過此次演講使國內製藥產業界深入了解這兩項法案在生技醫藥授權談判和投資策略的實際影響，協助臺灣因應未來生技製藥挑戰的藥品研發對策的制訂與接軌國際市場商業的規劃。

Speech photos
活動剪影

03/16/2023

3/25 International Conference on the Development and Regulatory Considerations for Complex Products
In recent years, the development of complex products has received considerable attention in the pharmaceutical industry. Complex products in the pharmaceutical industry refer to products that have complex active ingredients such as polymers, formulations such as liposomes, delivery methods, dosage forms, or complex drug-medical device combination products. Due to their complex nature, the development of these products is not only challenging but also poses regulatory challenges. To address these challenges, the International Conference on the Development and Regulatory Considerations for Complex Products is being organized by the Platform for Research and Inspiration in Regulatory Science at the School of Pharmacy, National Taiwan University. Experts and scholars from industry, government, and academia will be invited to share their insights on complex product development and regulatory considerations, with a focus on complex drug-device combinations and inhaled formulations. The conference will explore the current regulatory landscape, research considerations, and future challenges. The event will take place on March 25, 2023, from 09:30 to 16:00 in Room 101 of the Shui-Sen Hall at the School of Pharmacy, National Taiwan University. Participants from the pharmaceutical industry and related fields are welcome to register and attend!

3/25複雜產品開發及法規考量之國際研討會
近年來，在醫藥產業的發展中，複雜產品 (complex products)的開發受到相當的重視。醫藥品之複雜產品泛指具有複雜主成分 (如聚合物)、配方 (如微脂粒)、遞送途徑、劑型之藥品，或為複雜藥品-醫療器材複合性產品 (combination product)。複雜產品因其複雜的本質，不僅在產品研發過程充滿考驗，亦使法規管理深具挑戰性。為此，臺大藥學專業學院「國際藥政法規科學研究平台」籌辦此次「複雜產品開發及法規考量之國際研討會」(International Conference on the Development and Regulatory Considerations for Complex Products)，邀請國內外產官學界專家學者分別就複合性產品及吸入劑型、脂質載體藥品開發為主題，從科學面切入，深入解析及探討法規現況、研發考量、未來可能面臨的挑戰等。本項國際研討會將於 2023 年 3 月 25 日 (星期六) 09:30~16:00 ，假臺灣大學藥學專業學院水森館 101 室舉行，歡迎醫藥各界人士踴躍報名參加！

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活動簡章

03/08/2023

2/24 International Pharmaceutical Regulatory Science Symposium

The Platform for Research and Inspiration in Regulatory Science co-hosted the International Pharmaceutical Regulatory Affairs Symposium on February 24, 2023, which was organized by the Taiwan Society of Regulatory Affairs for Medical Products. Dr. Scott Grossman and Ms. Susan Chan, the foreign regulatory affairs directors of Merck Sharp & Dohme (MSD) company introduced the various measures adopted by the US FDA Oncology Center of Excellence (OCE) and their benefits to the industry, as well as to share practical experiences of MSD in the field. The panel discussion section was hosted by Prof. Churn-Shiouh Gau, the principal investigator of the Platform for Research and Inspiration in Regulatory Science and Prof. Jaw-Jou Kang, the Chairman of the Taiwan Society of Regulatory Affairs for Medical Products. Representatives from the non-industry council members of the Taiwan Society of Regulatory Affairs for Medical Products, the division of Medicinal Products, Taiwan Food and Drug Administration, and the Center for Drug Evaluation, Taiwan, as well as experts, scholars, and industry leaders were gathered together. The panelists discussed the progress of the US FDA's accelerated approval process and the opportunities for Taiwan to participate in Project Orbis Partners (POP), as well as exchanged observations and suggestions for further improvement on regulatory oversight for the domestic industry.

2/24 國際藥政法規專題演講「Introduction of US FDA Oncology Center of Excellence Initiatives and Project Orbis」

於2023年2月24日，國際藥政法規科學研究平台協辦，由台灣醫藥品法規學會主辦的「國際藥政法規專題演講」。Merck Sharp & Dohme（MSD）公司國外法規主管Dr. Scott Grossman和Ms. Susan Chan介紹美國FDA腫瘤卓越中心（Oncology Center of Excellence, OCE）所採取的各項措施及其對產業界的效益，並分享MSD的相關實務經驗。綜合討論由國際藥政法規科學研究平台主持人高純琇教授與台灣醫藥品法規學會理事長康照洲教授主持，邀請到多位專家學者、產業界先進以及相關機構代表參與，包括台灣醫藥品法規學會非業界理事、衛生福利部食品藥物管理署藥品組、財團法人醫藥品查驗中心等代表，針對美國加速審查流程的進展情況以及台灣參與Project Orbis Partners（POP）的合作機會，討論國內產業在法規管理方面的觀察和改善建議。

03/01/2023

03/13 Keynote Speech of Lawyer Chia-Feng Lu (呂家鋒)
The Platform for Research and Inspiration in Regulatory Science sincerely invites you to actively participate in the Keynote Speech of Lawyer Chia-Feng Lu!
Topic: The impact of Food and Drug Omnibus Reform Act of 2022 (“FDORA”) and Inflation Reduction Act (“IRA”) on the biopharmaceutical industry
Lecture outline:
The every-five-year Drug User Fee Act came to an end in December 2022. The Food and Drug Omnibus Reform Act, also known as FDORA, will have an impact on clinical trials, cell and gene therapy, supply chains, and real-world data applications in the United States (US). Meanwhile, the Inflation Reduction Act (IRA) introduces the first mechanism for the US government to intervene in drug price negotiations. Lawyer Chia-Feng Lu, who was involved in the negotiation of these two bills in Washington, DC, will discuss the key points and impacts on the biopharmaceutical industry. This speech will primarily focus on FDORA. If time permits, it will also address the potential impact of IRA on biotech licensing negotiations and investment strategies.
Speaker: Chia-Feng Lu / Greenberg Traurig - Senior Partner in Washington, D.C. and Tokyo/Osaka area
Speaker profile：Lawyer Lu specializes in biopharmaceutical and emerging technology businesses. He participates in emerging technology regulatory legislation, as well as negotiates licensing and mergers and acquisitions of cutting-edge technologies. Lawyer Lu has been involved in the world's first global licensing negotiation for immunotherapy, the acquisition of the division of cellular and gene therapies, as well as the development or launch strategies of three Nobel Prize-winning drugs. In addition, he provides consultation on biotech policies for the government agency.

Speech poster
Welcome to Registration

03/13呂家鋒律師專題演講
臺大藥學專業學院「國際藥政法規科學研究平台」誠摯邀請您踴躍參與「呂家鋒律師專題演講」！
演講主題：Food and Drug Omnibus Reform Act of 2022（“FDORA”）及Inflation Reduction Act（“IRA”）對生技醫藥業的影響
講題Outline：
每五年的使用者費付費法案已於2022年12月落幕。此次使用者付費法案（簡稱 FDORA），將對美國臨床試驗、細胞基因治療、供應鏈、真實世界數據的應用帶來影響。於此同時，降低通膨法案（IRA）也給予美國政府首次介入藥價協商的機制。呂家鋒律師在華府參與這兩個法案的協商，將分享對於此兩法案的重點以及對於生技製藥的影響。此次演講將著重在FDORA，若時間允許，會討論IRA可能造成生技醫藥授權談判和投資策略的改變。
主講人：呂家鋒律師 / Greenberg Traurig 律師事務所華盛頓特區&東京辦公室資深合夥人
主講人簡介：呂律師負責生技醫藥和新興科技業務，參與重要新興科技法案管制以及尖端科技的授權併購談判，曾參與第一例的免疫療法的全球授權談判，細胞基因治療部門的收購，以及三個諾貝爾獎藥品開發或上市策略，並提供政府部門其生技政策的諮詢。

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11/15/2022

The Platform for Research and Inspiration in Regulatory Science hosted the "Keynote Speech of Lawyer Chia-Feng Lu (呂家鋒)" on November 3, 2022. Lawyer Chia-Feng Lu is currently a senior partner of Greenberg Traurig Law Offices in Washington, DC & Tokyo. He graduated from the School of Pharmacy, National Taiwan University in 2004, and was awarded the honor of Outstanding Alumni in 2021. With the topic of "A stress test - survive or thrive in a new global environment", Lawyer Lu shared the new business layout of the United States under the User Fee Act and Inflation Reduction Act, analyzed the R&D and commercialization environment in China and Japan, and how to optimize the product portfolio under the latest business environment, in order to formulate a business strategy centered on Taiwan.

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國際藥政法規科學研究平台於2022年11月3日舉辦「呂家鋒律師專題演講」，呂家鋒律師現為Greenberg Traurig 律師事務所於華盛頓特區&東京辦公室之資深合夥人，也是臺大藥學系第48屆系友，且於2021年獲得傑出系友的殊榮。呂律師以” A stress test - survive or thrive in a new global environment”為講題，分享美國於User Fee Act 和Inflation Reduction Act下之新商業佈局，更分析中國和日本之產品研發與商業環境，以及如何依據最新商業環境下優化產品組合，擬定以臺灣為中心之商業策略。

活動海報

11/02/2022

The Platform for Research and Inspiration in Regulatory Science hosted the "Orphan Drug Accessibility Forum" on October 1, 2022 which was co-organized by the Ching Kang Foundation for Pharmacy Promotion and sponsored by Pfizer Taiwan. In the first half of this forum, Dr. Chao-Chun Wu (吳昭軍), Director General of the Health Promotion Administration of Ministry of Health and Welfare, was invited to share the medical care achievements through the implementation of The Rare Disease and Orphan Drug Act in the past 22 years. In view of the current situation and prospects for related drugs, Assistant Professor, Dr. Lin-Chau Chang (張琳巧) and Professor, Dr. Fei-Yuan Hsiao (蕭斐元) of School of Pharmacy, National Taiwan University were invited to share the viewpoints from registration and reimbursement aspects, respectively. In the second half of the forum, Ms. Serena Wu (陳莉茵), Director/Founder of the Taiwan Foundation for Rare Disorders, was invited to share the views and expectations from the perspectives of patients; and Ms. Josie Godfrey, Strategic Director of Project HERCULES, was also invited to share how the international pharmaceutical industry, government, and universities cooperate to collect data of patients with rare diseases. For the discussion section hosted by Professor, Dr. Yoa-Pu Hu (胡幼圃), Distinguished Visiting Chair of the Institute of Biomedical Sciences, Academia Sinica, representatives from the National Health Insurance Administration, Food and Drug Administration, and the Health Promotion Administration of the Ministry of Health and Welfare, Taiwan, as well as experts, scholars, and industry leaders were gathered together to discuss suggestions on the refinement of relevant domestic policies and regulations on the accessibility of orphan drugs.

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國際藥政法規科學研究平台於2022年10月1日主辦「罕病用藥可近性研討會」，感謝財團法人中華景康藥學基金會協辦及輝瑞大藥廠贊助！本活動上半場邀請國民健康署吳昭軍署長，分享罕見疾病防治及藥物法施行二十二年來之醫療照護成果；針對適用罕藥法藥品之現況及展望，邀請臺大藥學專業學院張琳巧助理教授與蕭斐元教授，分別就查驗登記及健保給付面向進行分享。下半場則邀請財團法人罕見疾病基金會陳莉茵董事/創辦人，分享罕見疾病病患觀點與期待；並邀請Strategic Director of Project HERCULES Ms. Josie Godfrey，分享國際間產官學界如何合作收集罕病病患資料；由中央研究院生物醫學科學研究所客座講座胡幼圃教授主持的綜合討論中，邀請到衛生福利部中央健康保險署、食品藥物管理署及國民健康署代表，以及專家學者和與產業界先進，針對罕見疾病用藥可近性討論國內相關政策法規之修訂建議。

活動海報

11/02/2022

The Platform for Research and Inspiration in Regulatory Science hosted the "Taiwan Patent Linkage System and Case Forum" on August 22, 2022 which was coorganized by the Taiwan Pharmaceutical Manufacture and Development Association. This event invited Chairman, Dr. Lee Fang-Chen to share his insights and experience on Taiwan's pharmaceutical patent linkage system and the challenges faced by domestic generic pharmaceutical companies. Attorney, Dr. Danny Kao was also invited to share the patent strategies of pharmaceutical companies in the US and suggestions for the domestic pharmaceutical industry. At the end of the forum, the panel discussion also invited representatives from the Taiwan Intellectual Property Office of the Ministry of Economic Affairs and the Food and Drug Administration of the Ministry of Health and Welfare, as well as experts, scholars and industry leaders, to discuss strategies and suggestions on the refinement of relevant domestic policies and regulations.

Forum poster

國際藥政法規科學研究平台於2022年8月22日主辦「臺灣藥品專利連結及案例論壇講座」，並感謝中華民國製藥發展協會協辦。本活動邀請中華民國製藥發展協會李芳全理事長，分享對臺灣藥品專利連結制度之見解與經驗，及現今國內學名藥廠面臨之挑戰；並邀請郭懷翃律師分享美國原廠專利佈局思維及提出國內製藥產業因應對策建議；綜合座談會也邀請到經濟部智慧財產局與衛生福利部食品藥物管理署代表，以及專家學者和產業界先進，討論產業之因應對策與國內相關政策法規之修訂建議。

活動海報

10/24/2022

11/03 Keynote Speech of Lawyer Chia-Feng Lu (呂家鋒)
The Platform for Research and Inspiration in Regulatory Science sincerely invites you to actively participate in the Keynote Speech of Lawyer Chia-Feng Lu!
Topic: A stress test - survive or thrive in a new global environment
Lecture outline:

‧	The new landscape under the latest User Fee Act and Inflation Reduction Act in the U.S.
‧	R&D and commercialization environment in China, Europe, and Japan
‧	Optimize the product portfolio according to the latest operation and dealmaking environment

Speaker: Chia-Feng Lu / Greenberg Traurig - Senior Partner in Washington, D.C. and Tokyo/Osaka area
Speaker profile：Mr. Lu assists biotech companies and emerging technology companies to understand the regulations applicable to their products, technologies and services, as well as assists with strategic legal requirements for the overall product business cycle, strategic cooperation, go-to-market, drug pricing, financial and life cycle management. Over the past decade, he has provided legal and strategic services for at least three Nobel Prize-winning products, including one that has become a blockbuster drug on the market. Mr. Lu has participated in the formulation and consultation of various pharmaceutical policies in the United States and Japan, such as The User Fee Act, The 21st Century Treatment Act, and the establishment of various regulations on artificial intelligence, personal medicine and cell therapy. Before joining the firm, he was responsible for product portfolio planning and market entry at Takeda and Celgene headquarters.

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Welcome to Registration

11/03呂家鋒律師專題演講
臺大藥學專業學院「國際藥政法規科學研究平台」誠摯邀請您踴躍參與「呂家鋒律師專題演講」！
演講主題：A stress test – survive or thrive in a new global environment
講題Outline：

‧	The new landscape under the latest User Fee Act and Inflation Reduction Act in the U.S.
‧	R&D and commercialization environment in China, Europe, and Japan
‧	Optimize the product portfolio according to the latest operation and dealmaking environment

主講人：呂家鋒律師 / Greenberg Traurig 律師事務所華盛頓特區&東京辦公室資深合夥人
主講人簡介：呂律師協助生技公司和新興技術公司瞭解適用於其產品、技術、服務的監管法規，並協助整體產品商業周期的策略法律需求、舉凡策略合作、上市途徑、藥價、財務和生命週期管理。在過去的十年裡，他為至少三項諾貝爾科學獎得獎的產品提供法律和策略服務，其中包括一項已在市場上成為重磅藥品的產品。呂律師參與美國日本多項醫藥政策制定和諮詢。譬如, 使用者付費法、二十一世紀治療法案，以及多項人工智慧、個人醫療與細胞治療法規建置。在加入事務所前，他曾在Takeda和Celgene總部負責產品組合規劃和市場進入。

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09/27/2022

10/01 Orphan Drug Accessibility Forum
The Rare Disease and Orphan Drug Act was formulated and published in 2000, which has been implemented for more than 20 years. Orphan Drug Accessibility Forum will be held in-person and online on October 1st. To review previous legislative achievements and look forward to future prospects, we will discuss the current situation, future challenges and possible coping strategies from the perspectives of industry, government and patient groups. Welcome to join us!

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Welcome to Registration

10/01 罕見疾病用藥可近性論壇
我國於2000年制定公布罕見疾病防治及藥物法，至今已施行超過20年。為回顧立法成果並展望未來發展，罕見疾病用藥可近性論壇將於10月1日以實體及線上方式同步舉辦，從產官學及病友團體之角度出發，探討現況、未來的挑戰及可能的因應策略。歡迎您共襄盛舉！

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07/29/2022

The Platform for Research and Inspiration in Regulatory Science held the second expert meeting for complex products on June 28, 2022, inviting experts and scholars from the academia, industry, and regulatory agency to continue the discussion in the first expert meeting on March 9, 2022. Besides the exchange of the opinions on the current domestic and international regulations on the complex drug-lipid platform, complex drug-device combination products (e.g., auto-injectors, metered dose inhalers), and other key areas, experts’ suggestions for the organization of the subsequent international symposium were collected.
Presently, fundamental review standards are implemented for complex products universally, with additional product-specific considerations. The regulations for registration of complex products in Taiwan have general rules in combination with case-by-case considerations depending on specific products. It is suggested that scientific communication should be conducted more often between the industry and the regulatory agency to facilitate the exchange of opinions, development process, and refinement of regulatory requirements.

國際藥政法規科學研究平台於2022年6月28日舉辦第二場Complex product專家會議，邀請多位來自學界、產業界及審查單位之專家學者，延續3月9日專家會議之討論議題，針對complex drug-lipid platform與complex drug-device combination products (e.g., auto-injectors, metered dose inhalers) 及其他重點領域之國內外法規現況交換意見，以及收集專家對於後續以此為題之國際研討會之建議。
目前國際上對complex product審查多採用一般原則，再依不同產品特性 (product-specific) 而有不同的審查考量。臺灣法規包含一般規範，並依據個別產品而有個案考量。建議藥業與審查單位多進行科學交流，有助於促進意見交換、研發進程、以及完善法規。

04/14/2022

Due to the complexity of Non-Biological Complex Drugs (NBCDs), the regulatory guidelines and standards are not entirely consistent across countries. Hence, the Platform for Research and Inspiration in Regulatory Science initiated an expert meeting to exchange views on domestic and international NBCD regulations on March 9, 2022, with experts and scholars from academia, pharmaceutical industries, and the regulatory authority.
Currently, besides the fundamental regulatory considerations, additional requirements may apply depending on product categories. Regulatory guidelines were often based on the consensus between pharmaceutical industries and the regulatory authority after cooperative negotiations and discussions. Additionally, an overall assessment of regulations must also be conducted regarding national health care policies and pharmaceutical industry development, such as patient accessibility and urgency, market conditions and scarcity. Experts suggested that the Taiwanese pharmaceutical industry should seek its own niche. Moreover, the regulatory authority should consider drafting appropriate and specific review guidelines.

由於Non-Biological Complex Drug (NBCDs) 之複雜性，審查方式與標準於各國間並未完全一致。因此，國際藥政法規科學研究平台於2022年3月9日舉辦專家會議，邀請多位來自學界、產業界及審查單位之專家學者，針對NBCDs之國內外法規現況交換意見。
目前國內外多於一般考量之外，依據NBCDs產品類別而有額外要求，審查指引常基於與業界合作協商與討論所得出之共識。此外，法規亦須視國家健保政策與產業界商業發展進行通盤評估，例如病人對此藥品之可近性與急迫性，及藥品市場情況與稀缺性。建議國內產業發展應尋找自身之利基，而政府單位應評估訂定合宜且明確之審查原則。

11/23/2021

In response to the COVID-19 pandemic, a symposium was jointly organized by the Platform for Research and Inspiration in Regulatory Science at the School of Pharmacy, National Taiwan University with the Taiwan Society of Regulatory Affairs for Medical Products and held on June 11, 2021 to collect opinions from experts and scholars regarding the Emergency Use Authorization granting principles for domestic COVID-19 vaccines. The topics included the discussion of the appropriateness to adopt Correlates of Protection (CoP) in the Emergency Use Authorization granting principles for domestic vaccines which was announced by the Center for Drug Evaluation, Taiwan and the Taiwan Food and Drug Administration on June 10, 2021 and the related issues such as the transparency of the vaccine review process, and suggestions on supporting measures. Please click here for the meeting minutes (Chinese version).

鑑於最近國內COVID-19疫情變化迅速，考驗我國是否有能力進行藥物自主審查，「台灣醫藥品法規學會」與「臺大藥學專業學院國際藥政法規科學研究平台」共同於2021/6/11舉辦此次座談會。就2021/6/10台灣食品藥物管理署(以下簡稱食藥署)與財團法人醫藥品查驗中心公布緊急使用授權(Emergency Use Authorization, EUA)之審查標準，與同日高端公布第二期解盲之結果，針對緊急使用授權審查標準與藥事法第48-2條之修改草案於本座談會中進行討論。
兩大議題與專家意見之細節，請參考摘錄。