HiRO - Harvest Integrated Research Organization’s Post

📦 Opening the 'Black Box' of Japanese Pharma Regulation ❓ Several misunderstandings abound about the Japanese pharma market: most notably that its regulatory system is extremely complex and demanding. This is leading multinational drug developers to look elsewhere for clinical development and eventual product launches. 🚪 However, as PMDA Senior Executive Director Shinobu Uzu tells PharmaBoardroom, this is a missed opportunity. In conversation at DIA Europe 2024, Uzu pointed out that not only is Japan the third largest pharma market in the world, but its regulatory harmonisation efforts in ASEAN make it a ‘gateway to Asia.’ This means a potential 780 million people and USD 840 billion market. 🗨 Uzu also outlines how PMDA – via its new Washington DC office – is proactively engaging with the US biotech industry to spread awareness of the market access opportunities in Japan as well as its friendly and straightforward regulatory environment for clinical trials. 🔝 As a founding member of the ICH and the leading regulatory agency in the region, PMDA is hoping to bolster its international reputation even further through proactive engagement with other national regulators, international bodies, and individual companies – both big and small. Learn more at https://lnkd.in/dnxXJ2-V Daisuke T. Patrick Burton #DIAEurope2024 #PMDA #Japan

𝐍𝐞𝐰 𝐌𝐇𝐋𝐖 𝐆𝐮𝐢𝐝𝐚𝐧𝐜𝐞 𝐀𝐢𝐦𝐬 𝐭𝐨 𝐅𝐚𝐜𝐢𝐥𝐢𝐭𝐚𝐭𝐞 𝐈𝐧𝐜𝐥𝐮𝐬𝐢𝐨𝐧 𝐨𝐟 𝐉𝐚𝐩𝐚𝐧𝐞𝐬𝐞 𝐏𝐚𝐫𝐭𝐢𝐜𝐢𝐩𝐚𝐧𝐭𝐬 𝐢𝐧 𝐆𝐥𝐨𝐛𝐚𝐥 𝐂𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐓𝐫𝐢𝐚𝐥𝐬 The Ministry of Health, Labour and Welfare (𝐌𝐇𝐋𝐖) in Japan is transforming global clinical trials with its groundbreaking new guidance. Traditionally, sponsors faced delays as they conducted additional phase 1 studies with Japanese participants before including 𝐉𝐚𝐩𝐚𝐧 𝐢𝐧 𝐠𝐥𝐨𝐛𝐚𝐥 𝐭𝐫𝐢𝐚𝐥𝐬. This outdated approach often slowed down the approval of new medicines in Japan. Now, 𝐌𝐇𝐋𝐖 is paving the way for a more efficient process. By removing the requirement for additional phase 1 studies for drugs where early clinical development is occurring outside Japan, the new guidance aims to expedite drug development. This means faster access to innovative treatments for Japanese patients and a more streamlined global trial process. This initiative not only accelerates drug development but also fosters greater inclusion of Japanese participants in global studies, ensuring diverse and comprehensive data. 𝐀𝐮𝐭𝐡𝐨𝐫: HASEGAWA Mayumi 🔗 𝐋𝐞𝐚𝐫𝐧 𝐌𝐨𝐫𝐞:  https://lnkd.in/gqFDF2MR 🔗 𝐃𝐨𝐰𝐧𝐥𝐨𝐚𝐝 𝐲𝐨𝐮𝐫 𝐜𝐨𝐩𝐲 𝐡𝐞𝐫𝐞: https://lnkd.in/gTCs4cpe #ClinicalTrials #DrugDevelopment #MHLW #PharmaInnovation #GlobalHealth #ClinicalResearch #JapanHealthcare #PharmaNews #MedicalInnovation #HealthcareRevolution #Biotech #Pharmaceuticals #HealthPolicy #GlobalTrials #InnovationInHealth

今年度10月5日-6日「第十一屆台日醫藥交流會議」順利辦理完成，這在近半年的籌畫過程中，感謝署內的各個長官同仁，也很感謝日本厚生勞動省以及PMDA長官的大力支持與參與，能讓本次的會議這麼精采和充實。 "The 11th Joint Conference of Taiwan and Japan on Medical Products Regulation" on October 5-6th this year was successfully completed. During nearly half year planning process, thanks all the colleagues in TFDA, and also strong support and participation from Japan MHLW/PMDA officials, which made a robust communication and collaboration in this conference. After this conference, it's time for traveling to Japan with some vacation😊 More Conference information can be seen below: https://lnkd.in/gcJxcWDH

Steady drug development growth in the China has translated into many innovative drug approvals that improve patients’ quality of life around the world. While immense opportunities as being best-in-class or first-in-class innovative products with strong potential to address unmet medical needs globally, China based biotech companies still are facing common partnership challenges in their global development journey as they attempt to seamlessly advance their assets to the next stage of development and increase their speed to market. The discussion will focus on the development landscape and ways and means to maximize the value of Biotech portfolio and how a strategic collaboration with a best-in-class CRO can help in achieving your development goals. Voices from the industries are being heard. Focusing on key challenges in competitive landscape at the investigator sites, evolving global regulation and market entry, in-depth conversation are conducted to find out how global CRO would expedite drug development and drive better value to China local clients. We’re looking forward to meeting you in Suzhou! Time: May 17 15:30 -18:00 Venue: 2F New York & London Hall, SIP Novotel, Suzhou, China Click to join: https://lnkd.in/edW9MSGD

New Opportunities: Japan's Game-Changing Move for Global Clinical Trials! Japan has taken a monumental step forward in accelerating global clinical trials. With the aim to address the 'drug lag' in Japan, the Ministry of Health, Labour and Welfare (MHLW) has announced that, in most cases, Phase 1 drug clinical studies won't be necessary before proceeding to late-stage global studies. This move is primarily geared towards drugs in high demand such as orphan and pediatric drugs. From a regulatory point of view, it simplifies the previously established guidelines from 2007 and 2014. Why this change? To keep up to pace with global developments, it's crucial for Japan to streamline its clinical trial processes. This decision comes as part of Japan's strategy to facilitate quicker access to essential drugs, especially where there's an urgent need. You can say that this is a fallout from Japan's torturously slow approval of COVID-vaccines during the pandemic. What does this mean? 1. Reduced Costs & Time: The removal of the Phase 1 requirement can save huge resources (time, money) to be spent elsewhere. Being more useful. 2. Facilitated Market Access: This new regulation makes it easier to introduce drugs to the Japanese market. However: Keep in mind that while the MHLW has eased the Phase 1 requirements, you should still be prepared to follow the old protocol in specific situations. Hence, a well-strategized approach to clinical trials in Japan, or any market, remains essential. Illustration by: DreamShaperXL v2 AI While this is a giant leap forward, it's important to remain vigilant and adhere to MHLW's recommendations. #Japan #ClinicalTrials #Pharmaceuticals #BusinessOpportunities #Innovation #GlobalMarkets #HealthcareTrends

JAPAN CLINICAL TRIALS Why choose #Japan for conducting clinical trials? Explore its state-of-the-art medical facilities, rigorous regulatory standards, world-class scientific expertise, and captivating cultural heritage. #ClinicalTrials #ResearchInJapan #pmda Click on the link below to discover why you should choose Japan for your clinical trials and learn about the regulatory process for conducting clinical trials in Japan. 👉 Contact @Credevo for conducting clinical trials in Japan https://buff.ly/48bKS9O

Evidence generation and launch strategies in China >> https://lnkd.in/e3Tir58z Markets in the Asia-Pacific region are evolving in ways that are challenging established approaches to policy, access, value, and evidence, In this update, we share examples from China to highlight several implications for evidence generation and launch strategies...https://lnkd.in/e3Tir58z #HEOR #MarketAccess #prmaAPAC

Evidence generation and launch strategies in China >> https://lnkd.in/e3Tir58z Markets in the Asia-Pacific region are evolving in ways that are challenging established approaches to policy, access, value, and evidence, In this update, we share examples from China to highlight several implications for evidence generation and launch strategies...https://lnkd.in/e3Tir58z #HEOR #MarketAccess #prmaAPAC

The countdown has begun! Just 3 days left until the much-awaited Outsourcing in Clinical Trials East Asia 2023 kicks off at the JW Marriott Hotel Seoul, South Korea. This conference isn't your typical industry gathering. It's a focused platform tailored specifically to address the unique challenges and opportunities in the Asian pharmaceutical landscape. Expect insightful discussions on prevailing industry hurdles, coupled with visionary solutions and unprecedented growth insights. Join us alongside prominent industry figures and thought leaders for an unparalleled opportunity to transcend boundaries, foster collaboration, and drive the industry towards a brighter, more innovative future. Ready to be a part of this transformative experience? Mark your calendars for 5th-6th December and join us at OCT East Asia 2023! #OCTEastAsia2023 #ClinicalTrials #InnovateForTomorrow

JAPAN CLINICAL TRIALS Why choose #Japan for conducting clinical trials? Explore its state-of-the-art medical facilities, rigorous regulatory standards, world-class scientific expertise, and captivating cultural heritage. #ClinicalTrials #ResearchInJapan #pmda Click on the link below to discover why you should choose Japan for your clinical trials and learn about the regulatory process for conducting clinical trials in Japan. 👉 Contact @Credevo for conducting clinical trials in Japan