Singapore has become a global center for the pharmaceutical industry due to its cost-effective and reliable medical services, high-quality pharmaceutical manufacturing and research, access to regional markets, and skilled workforce. Also, the Government has supported several schemes to drive innovation and development. This has created many manufacturers to register their generic products in Singapore. The […]

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The Philippines is the third-largest pharmaceutical market in ASEAN after Thailand and Indonesia. In 2019, total generic drug sales were in the Philippines were PHP82.3 billion, and accounts for 63% of prescription sales and estimate to reach PHP110 Billion by 2024. The highest cost of medicines in the Philippines among other ASEAN countries is one […]

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Myanmar’s pharmaceutical market size was $456 million in 2017, with a percapita pharma expenditure of $8.5 and market researchers expect to reach $656 million in 2022. Myanmar’s economy is growing continuously, and the experts predict the pharmaceutical industry to quickly grow into a $1.12 billion industry in the future. Myanmar depends on the import of […]

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The Vietnam generic drug market is growing rapidly with increasing interest in many overseas manufacturers to register their drugs. Vietnam’s pharmaceutical market, along with generic drugs, has grown significantly in the last two years by 10% to US$5.2 billion and is estimated to reach US$6.6 billion this year. This expanding market growth contributes to the […]

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This article is a sequence of the Regulatory & Drug Approval Process in the United States, Part-I, which describes the Investigational New Drug (IND) approval process, New Drug Approval (NDA), and Generic drug approval process. In this article, we will discuss the market approval process of biologics, biosimilars, orphan drugs, and various drug approval pathways.  Which is the regulatory authority […]

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The drug approval process in Japan is less complex and easy when compared to some other countries beyond the language barriers. In addition to regulatory considerations, the PMDA offers sponsors consultation to assist them in understanding the prerequisites and the detailed procedure for drug approval. As a result of this positive change, many manufacturers choose […]

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