Zuellig Pharma’s Post

We recently joined Vietnam's National Institute of Drug Quality Control (NIDQC) and Indonesia's BADAN PENGAWAS OBAT DAN MAKANAN [National Agency of Drug and Food Control] (BPOM) to discuss continuing and expanding our collaborative work focused on advancing medicine quality and safety. USP CEO Ronald Piervincenzi joined NIDQC to sign the renewal of our memorandum of understanding (MOU)—a continuation of a decades-long collaboration between—US Pharmacopeia and NIDQC. Ron and our senior leadership team also met with BPOM to discuss expanding coordinated efforts through a formal MOU across several priority areas. These included facilitating BPOM to adopt/adapt USP quality standards to strengthen Indonesia's pharmacopoeia, offering technical training for oversight of advanced therapies, supporting BPOM's progress toward becoming a WHO-Listed Authority, and expanding BPOM lab access to USP content. Both meetings showcase our commitment to leveraging regulatory collaboration worldwide and advancing public health through improved medicines supply chain resiliency, regulatory and pharmacopeial convergence, and harmonization. For more about our work to support the global supply of quality medicines, read our white paper ⤵ and visit Ow.ly/gOsQ50QFnnt to learn about our Preferential Access for Regulators (PAR) Program. #Pharma #GlobalHealth World Health Organization

In response to the urgent need for improved drug safety in Indonesia, BPOM enacted Regulation 10/2024, mandating strict labeling standards for natural medicines and health supplements by June 2026. Nashatra Prita (Partner) and Yasyfa Alifya Radiany (Associate) explore the critical aspects and implications of this regulation, highlighting the essential types of requirement on labels to ensure they are complete, accurate, and non-misleading. Discover the key steps for compliance and the impact on your business operations in their insightful analysis, essential for distributors and foreign principals supplying to Indonesia. Read more article: https://bit.ly/3zXLseT

This new labeling regulation has significant impact for medicine and health supplements supply to and within Indonesia. Essential for foreign principals and local distributor to comply to ensure sustainability of their business in Indonesia #healthcarelaw #healthcareindustry #healthcarelegalupdate

Your journey to open a medical business awaits!🔍 📌 Did you know that Thailand is the 2nd largest pharmaceutical market in Southeast Asia? The low cost of medical equipment as compared to other countries led to a rise in Thailand's medical tourism. Read out our checklist NOW ⬇ List of steps to follow for starting a medical business in Thailand: 📌 Registration and Licensing ◾ Obtain a license from the Foreign Business Committee for commercial activities. ◾ Secure approval from the Thailand Board of Investment (BOI). 📌 BOI Promotion Areas ◾ Pharmaceutical products ◾ Medical food and supplements ◾ Hygienic products ◾ Hospital machinery ◾ Rehabilitation centers ◾ Clinical research hubs ◾ Pharmacare centers 📌 Required Licenses ◾ Medical Service Business License ◾ Factory License ◾ Science Laboratory Capacity Certificate ◾ Food and Drug Administration (FDA) Permission under the Thai Drug Act, 1967 Tax Benefits 🔹 Corporate Income Tax (CIT) exemption for 3–8 years under BOI certification. 🔹 50% reduction in CIT for up to 5 years. 🔹 Only imposed on machinery imports related to R&D projects. For more information on registering your business, 📩 officer@konradlegal.com. #businessgrowth #businessideas #businesstips #businessowner #businessstrategy #growthhacking #startup #thailand #thai #legalsolutions

🇹🇭 Thailand #RegulatoryUpdate: The Thai Food and Drug Administration has issued a critical infographic alert concerning the cancellation of listing approval certificates. This action is taken when medical devices are incorrectly classified in terms of risk, highlighting the importance of accurate documentation and compliance with regulatory standards. Explore our latest article to understand the potential triggers for such cancellations and how to ensure your medical device classifications are correct. Stay informed and proactive in maintaining compliance. More details 👇

Katungi Samuel, a Pharmacist at Masaka Regional Referral Hospital, embarks on his journey with the International Pharmaceutical Federation (FIP) supported CLC course, expressing his intention, "I will apply the knowledge, skills, and experience acquired to support capacity building of health workers in general supply chain management, including inventory management, good storage and distribution practices, forecasting/quantification, and adherence to laws/regulations regarding distribution, importation, storage, and appropriate use of medical supplies in East Africa and globally. Furthermore, the course will enable me to continuously learn and adapt, innovate, work in multicultural work-based environments, gain outstanding analytical and negotiation skills to contribute to the design and implementation of efficient supply chain systems." As he commits his time and energy into the program, his dedication resonates with the commitment to collaborative learning and professional growth that he expressed. #beeskilled #coursexpectations #CLCcourse #FIPsupported 

EO - TRANSFORMING NIGERIA’S HEALTHCARE SECTOR BY INCREASING LOCAL PRODUCTION OF HEALTHCARE PRODUCTS It's been an incredible journey since the Director General of the National Agency for Food and Drug Administration and Control (NAFDAC) embarked on reforming and transforming our agency into a robust, stable, and efficient regulatory body. Today, we proudly reflect on these efforts and say: THE EFFORTS ARE PAYING OFF!!! 🔹🔹 Achievements Along the Way: 🔹ISO-9001-2015 Accreditation (2019) 🔹Recognized as a Maturity Level 3 Agency in Medicines 🔹WHO Prequalified Laboratory status for the Central Drug Control Laboratory in Yaba, Lagos 🔹🔹 Key Regulatory Directives: 🔹GMP Road Map (2018): Ensuring compliance with international standards 🔹Five-Plus-Five RD (2019): Maximizing local manufacturing capacity 🔹Pharma Operations Division (2019): Enhancing oversight and compliance 🔹Layout Review RD (2021): Incorporating quality into facility design 🔹Ceiling 34 Regulatory Directive (2021): Increasing local medicinal product capacity 🔹Hand Holding and Targeted Inspection (2023): Ensuring international standards for medical devices and IVDs 🔹🔹 Impact on Local Manufacturing: 🔹30% increase in new facilities built 🔹Strengthened local manufacturing partnerships 🔹Enhanced confidence and facility redesigns, even during the pandemic Despite challenges, including the high cost of importing materials, we've advocated for zero tariffs to support local manufacturers. 🔹 A New Era Under the Tinubu Administration: With the support of President Tinubu and the Coordinating Ministers of Health and Social Welfare, Prof. Mohammed Ali Pate and Dr. Tunji Alausa, we are witnessing transformative changes. The newly signed Executive Order brings groundbreaking measures: 🔹Zero Tariffs and Excise Duties on pharmaceutical machinery and raw materials 🔹Special Waivers on Pharmaceutical Inputs 🔹Market Shaping and Regulatory Harmonization 🔹Implementation and Compliance mandates This EO aligns with the Nigeria Health Sector Renewal Investment Initiative (NHSRII) and the Presidential Initiative on Healthcare Value Chain (PVAC), addressing key challenges and paving the way for a high-quality, sustainable healthcare system for all Nigerians. Together, we are transforming Nigeria's health sector for a brighter, healthier future! 🌟 #NAFDAC #HealthcareReform #LocalManufacturing #QualityManagement #HealthInnovation #NHSRII #NigeriaHealthCare #ExecutiveOrder

#RegulatoryNews, Ethiopia Ethiopian Food and Drug Authority (EFDA) published list of recalled products from Ethiopia market in the last few years, EARAPA, 26 May, 2024 The Ethiopian Food and Drug Authority (EFDA) recalled different batches of 25 medical products from the Ethiopia market in last couple of years. The Authority mentioned the reason for recall of products is found "substandard" as per the quality standards set in the country regulation. The recalled products were manufactured in different countries; mainly India (13), China (5) and domestically manufactured in Ethiopia (4) and distributed in the Ethiopia market. The recalled product list (attached below) was/is published and accessible on the official website of the Authority. However, the list/form has no issue date or authorization signatory and/or official stamp of the authority. EFDA is working hard towards achieveing WHO maturity level 3 in medicine regulation and EARAPA appreciates such transparency in regulatory decisions and recent impresive developments made by the authority. We hope the information will help other smaller agencies of neighboring countries for further verification of the products listed.

Ethiopia banned Ranitidine use in Ethiopia healthcare market. The Ethiopian Food and Drug Authority (EFDA) released circular letter regarding the safety concerns of the drug product on 20th May 2024 for the prescribers, dispensors and the Ethiopian community to accordingly stop use of the ranitidine. The authority announced in the safety alert that the product is banned due to high level of NDMA impurity upon randomly selected APIs of the drug in the market, stating that it was found as large as 12 folds of the acveptable limit of NDMA impurity in the products tested. The Authority didn't indicate for the fate of the already distributed or imported ranitidine product stocks in the market #regulatoryaffairs #regulatory #regulatorysubmission #EFDA

𝐔𝐧𝐥𝐨𝐜𝐤𝐢𝐧𝐠 𝐭𝐡𝐞 𝐅𝐮𝐥𝐥 𝐏𝐨𝐭𝐞𝐧𝐭𝐢𝐚𝐥 𝐨𝐟 𝐘𝐨𝐮𝐫 𝐇𝐞𝐚𝐥𝐭𝐡 𝐒𝐮𝐩𝐩𝐥𝐞𝐦𝐞𝐧𝐭 𝐢𝐧 𝐌𝐚𝐥𝐚𝐲𝐬𝐢𝐚 Ensuring compliance with NPRA regulations is key to registering your health supplement in Malaysia. The NPRA ensures product safety and quality, and their detailed guidelines can help you through the process; 𝗔𝗽𝗽𝗲𝗻𝗱𝗶𝘅 6: 𝗚𝘂𝗶𝗱𝗲𝗹𝗶𝗻𝗲 𝗼𝗻 𝗥𝗲𝗴𝗶𝘀𝘁𝗿𝗮𝘁𝗶𝗼𝗻 𝗼𝗳 𝗛𝗲𝗮𝗹𝘁𝗵 𝗦𝘂𝗽𝗽𝗹𝗲𝗺𝗲𝗻𝘁𝘀 ⁉️ Did you know the NPRA has stringent limitations on what health claims supplement companies can make? This could mean your amazing product's true potential might be downplayed. NPRA approval is a rigorous process, but it guarantees that consumers receive a product with substantiated claims. This builds consumer confidence and opens doors to a wider market. Let's leverage our NPRA expertise to streamline the process and secure swift approval for your supplement. Imagine your winning formula reaching health-conscious Malaysians! Novavita is just one call away! 🔔 #NPRA #MOH #regulatoryaffairs #regulatoryupdate #guidelines #regulations #malaysia #standard #international #consultant #cosmetics #beauty #drugs #pharmaceuticals #healthsupplement https://lnkd.in/gz5CTies