Speyside’s Post

As part of its 10th Anniversary, I was privileged to be invited by the Asia Pacific Medical Technology Association (APACMed) to share my views on the current and upcoming political landscape and its implications for the healthcare and MedTech industry in Indonesia on this Webinar. At the outside, I highlighted that with over 250 million Indonesians, or 90.34% of the population, covered under BPJS-Kesehatan (National Health Insurance) but served by only approximately 3,000 hospitals and 10,000 Puskesmas (primary health care), the need for advanced and modern medical devices will continue to grow to ensure effective and efficient treatment. The government should, therefore, encourage more open, collaborative, and predictable investment and trade policies in the healthcare sector to accommodate this. I also shared that while significant policy changes may not occur during the political transition period, the next administration will likely maintain and advance several existing healthcare policies. These include halal certification for medical devices, implementing policies of the Omnibus Law on Health, and local content requirements (TKDN). Even though some of these policies may present challenges for the healthcare industry, the new administration also offers a fresh start to reassess and enhance collaboration between the government and industry players and practitioners to address the evolving needs for improved healthcare across Indonesia. Thank you once again, APACMed, for the opportunity! #APACMed10thAnniversary #MedTechIndonesia #HealthcarePolicy #MedicalDevices #PublicHealth #PolicyInsights #HealthTechInnovation #IndonesianPolitics

Trial starts from China-headquartered companies have risen to 28% of trial starts from 3% a decade ago. #ChinaClinicalTrials #GlobalClinicalTrials #ClinicalTrialGrowth #ChinaHealthcare #ClinicalResearchChina #ChinaBiotech #HealthcareTrends #ClinicalTrialExpansion #ChinaHealthResearch #ClinicalTrialStatistics

📢 Our Keynote Speaker today @1:30pm : Mitsuhiro Marumoto, Ph.D., Country Manager at AKT Health Inc., will speak on '#Regulatory Systems in #Japan: Navigating Healthcare Advancements' at GVHS 2023! Join us by clicking the link below: https://lnkd.in/gg2WztgB Join Mitsuhiro Marumoto, for insights drawn from 36+ years in Pharma. Learn about Japan's regulatory landscape and tech integration in healthcare. Don't miss this expert perspective! Don't miss this opportunity to gain key #regulatory insights from an industry expert! #rpm #GVHS2023 #healthcareevent #digitaltransformation #healthcaretransformation #innovation #dct #clinicaltrials #regulatory # #regulatoryaffairs #japan #healthcare

🚨 Breaking Healthcare News from Ho Chi Minh City! 🚨 A significant update in the healthcare sector that will have a profound impact on patient care in Ho Chi Minh City. The city has been granted the authority to proactively import specialized and rare drugs to meet the urgent treatment needs of our medical facilities. Under the new Decree No. 84/2024/ND-CP, Ho Chi Minh City can now manage certain aspects of healthcare independently, including the importation of essential drugs for special treatments. This will help overcome the challenges our healthcare centers have faced in securing adequate drug supplies, particularly for primary healthcare facilities. This proactive approach not only strengthens our local healthcare system but also sets a precedent for other regions. 💾 Source: Decree 84/2024/NĐ-CP ⛔ Youtube news: https://lnkd.in/gugCvb8z #Healthcare #HoChiMinhCity #Pharmaceuticals #PublicHealth #MedicalInnovation #VietnamHealthcare

📢 The Spanish Ministry of Health has just released the highly anticipated Draft Royal Decree on #HTA, marking a significant step forward in the regulation of health technologies in Spain. This new framework will not only redefine how HTAs are conducted but also align Spain's process with the upcoming EU-HTA regulations set to take effect in 2025. 𝐊𝐞𝐲 𝐡𝐢𝐠𝐡𝐥𝐢𝐠𝐡𝐭𝐬 𝐢𝐧𝐜𝐥𝐮𝐝𝐞: 🔹 Establishment of a 21-member Governance Council, including representation from autonomous communities 🔹 Creation of two specialised offices for evaluating the efficacy of medicines and other health technologies 🔹 Alignment with EUnetHTA's nine assessment domains, integrating both clinical and non-clinical factors 🔹 Increased emphasis on real-world data and patient involvement in the evaluation process For manufacturers and market access professionals, this is a pivotal development that will shape the future of product launches in Spain. Read more about the implications of this Draft Royal Decree in our latest blog ➡ https://lnkd.in/evz2N5ua #MarketAccess #Healthcare #Pharma #EUHTA #PatientAccess #HeathTechnologyAssessment

Grateful to be working alongside a team passionate about clinical trial access in Singapore - Atul Chaudhari, Luisiawati Khalil, Kunal Shah, PMP®, Alvin Ong, and Joyce Lim. Public-private collaboration is crucial for accelerating medical advancements in Singapore. By bringing together the expertise and resources of both sectors, a synergistic approach emerges, enabling faster development and testing of new treatments. This collaboration enhances the efficiency of clinical trials, ensuring a diverse participant pool and comprehensive data collection. Moreover, this partnership strengthens the nation's position as a hub for cutting-edge research, attracting pharmaceutical companies and boosting the local economy. Ultimately, it contributes to the well-being of Singapore's population by expediting the availability of novel therapies and improving healthcare outcomes. #clinicaltrialaccess #publicprivatepartnership #medicaladvancements #innovation #singapore #healthcare #noveltherapies

Unlike in developed countries where RWD is well commercialized (well, sort of), RWD business in emerging markets is hard to grow. One solution is to create a special zone for RWD, with specialized policies to stimulate its growth. Hainan is such a magical island of RWD/E in China; Telangana may be an RWE heaven in India. But can this model, created by government, survive and flourish in free market? In 2024 Chinese Medical Affairs Conference, a group of RWD/E scientists discussed this question. From left, Prof Yang Yu, West China Hospital; Dr. Li Xie, Head of RWE, Happy Life Tech; Dr. Sha Tao, Head of RWE China, Roche; myself; Dr. Yue Wang, Head of Digital Med, AZ China; Lisa Sun, General Manager, TigerMed; Dr. Tony Guo, VP IQVIA. What did we learn during the 2 hour discussion? With strong support from government, it’s easy to survive. But to flourish, they need to go out of the comfort zone and open its mind for collaboration.

🌟𝐑𝐞𝐠𝐢𝐬𝐭𝐫𝐚𝐭𝐢𝐨𝐧 𝐔𝐧𝐯𝐞𝐢𝐥𝐞𝐝: 𝐘𝐨𝐮𝐫 𝐆𝐚𝐭𝐞𝐰𝐚𝐲 𝐭𝐨 𝐂𝐡𝐢𝐧𝐚 🌟 This week's Q&A is about the things you need to know about change medical device scope of application: Q: If an active product wants to change its indications for use only, can it be extended through clinical evaluation?   A: There are two cases: first, if the expanded indication is in the exempted clinical catalogue, the documents can be submitted in accordance with the exempted clinical guidelines; second, if the expanded indication is not in the exempted clinical catalogue, clinical evaluation should be conducted in accordance with the clinical evaluation guidelines. 👉If you want to know more about medical device change and China's Clinical Evaluation Reports (CERs), please click here! https://lnkd.in/g_D7tTKa Don't let regulations stop you. Get in touch with MediCore today! #china #medicaldevices #clinicalevaluation #medicore

Singapore is one of the top destinations in the region for clinical trials, [1] with 1,561 clinical trials conducted between 2012 and 2022, according to the Health Sciences Authority (HSA)[2]. Professor John Lim, Executive Director of the Centre of Regulatory Excellence (CoRE), Duke-NUS Medical School and Chairman, Consortium for Clinical Research and Innovation, Singapore (CRIS), and Ms Yeoh Ying Ying, Chair of Research & Development Committee (RDC) SAPI, share their insights on how creating a robust R&D ecosystem can foster economic growth and enable better access to transformative drugs for patients. Source: 1. https://lnkd.in/gYERjR6S 2. https://lnkd.in/gBd77wFs #SAPI #clinicaltrials #research #medicalresearch #singapore #medicalinnovation #healthcare

The new medical device (MD) procurement policy in Hong Kong will enter its Phase II from 1 November 2024, where all MDs in quotations submitted to the Department of Health (DH) must have either: - already been approved (listed under the Medical Device Administrative Control System) or - been granted a listing application number (under review by the regulator).   It is expected that by 2025, only listed MDs will be accepted by DH.   This is an enhancement of the Phase I strategy implemented in June 2023 where “listed MDs” were “given preference” in the tender/bid/quotation process in Hong Kong. Given that the public healthcare sector makes up a much larger proportion of the healthcare system compared to private healthcare providers in Hong Kong, this 2nd phase signifies that the device approval process is moving from a “voluntary” to “almost mandatory” system in 2025.    Contact #PharmaLex if you have any query relating to your #HongKong approvals. https://lnkd.in/gY8hyzEr https://lnkd.in/g7DnaCF5