Singapore’s Health Sciences Authority (HSA) is planning to transfer regulatory control of drug products, currently regulated under the Medicines Act and the Poisons Act, to the Health Products Act. The HSA believes that this will help update, clarify and streamline Singapore’s existing... Read More
Joko Widodo was inaugurated as the new President of Indonesia on October 20, 2014. One of the tough challenges Widodo’s administration will face is reforming the healthcare system. Indonesia has a complicated, decentralized healthcare system that spreads responsibility from the national level... Read More
In August 2014, the Association of Southeast Asian Nations (ASEAN) -- which includes Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand and Vietnam -- signed the ASEAN Medical Device Directive (AMDD). The AMDD creates a harmonized regulatory model for ASEAN... Read More
泰国食品和药物管理局（FDA）最近宣布，对于药品注册申报资料实行电子版通用技术文件（eCTD）试点。该试点项目将于2014年10月开始。从试点中获得反馈后，泰国FDA的电子提交系统将于2015年5月全面实施。 Read More
The Thai Food and Drug Administration (FDA) recently announced an electronic common technical document (eCTD) pilot program for drug application dossiers. The pilot program will start in October 2014. After feedback from the pilot, the Thai FDAs electronic submission system will be... Read More
The past several months have seen several announcements by the Malaysian Medical Device Authority (MDA). First launched in mid-2013, the online Medical Device Centralized Application System (MEDCAST) was expanded to support in vitro diagnostic (IVD) device submissions in May 2014. The MDA... Read More
Economic growth in Asia will be almost 6% in 2014 (excluding Japan), compared with 1.5% in the EU and 2.5% in the U.S. Asia's growth will be led by China, which is expected to expand over 7% this year. The economies of... Read More
Malaysia's pharmaceutical market is valued at over $3 billion and has a double-digit annual growth rate. Thanks to an increasingly affluent and expanding middle class, an aging population, urbanization and higher quality healthcare and medicines, Malaysians spent about $400 per person on... Read More
The pharmaceutical market in Thailand had a 2013 value of more than $4.5 billion, almost the same size as the Taiwan market. Already the second largest in Southeast Asia (behind Indonesia). the Thai drug market is projected to double by 2020. Read More
柬埔寨是一个拥有一千五百万人口的国家， 2013年国内生产总值约一百五十五亿， 每年大约有7％的增长。随着柬埔寨经济的发展，医疗保健消费也在全国各地不断扩大。和邻国相比，柬埔寨国家相对较小，医药产品销售比较困难。目前柬埔寨的医疗市场正纳入一条积极向上的轨道，该市场应该很快得到西方医疗设备和制药公司的更多关注。 虽然传染性疾病，如肺结核和疟疾是柬埔寨的首要死亡原因，但西方的某些疾病，如高血压和糖尿病也越来越普遍。在过去的十年中，由于免疫率的显著提高和实施国家疾病控制计划，传染病发病率已经得到控制。事实上2013年，柬埔寨比上一年同期下降了60％的登革热病例。 2015年柬埔寨的医疗保健市场价值将近十亿美元，包括价值2.1亿美元的药品市场。 该市场每年有超过10%的增长。2013年人均医疗保健支出为近60美元。按照东盟要求，柬埔寨药品注册相对便宜，并只需要一年的注册时间。柬埔寨没有政府控制的药物或药物报销系统。几乎80％的药品销售都在金边及周边地区，药品销售分布相对比较简单。 目前约55％的药品市场是由进口药品控制，当地居民优先考虑使用外国药品。外资机构已经开始注意到这一特点。制药巨头赛诺菲在所有柬埔寨24个省市建立自己的机构。去年12月，日本与柬埔寨签署了谅解备忘录，日本将对柬埔寨提供先进的医疗系统。2015年开始日本将在金边建设国家最先进的重症监护和急救医院。 当然，外国公司在柬埔寨做生意仍然面临许多问题 – 如腐败，基础设施不足，假冒药品和官僚作风。然而，随着柬埔寨的发展，西方的医疗产品公司应密切关注该国日益增强的医疗市场。 Read More