In a sign that China intends to increase its scrutiny of foreign medical device and drug companies, its regulators are instituting a process for inspecting overseas medical manufacturing facilities. The new guidelines announced in late December by China’s National Medical Products Administration... Read More
Seeking to codify higher standards for the production, transportation and storage of vaccines, Chinese authorities in January drafted a draft Vaccine Administration Law that would tighten restrictions on vaccines. Under the draft law, companies, firms or non-profit organizations are subject to government... Read More
With Singapore continuing to attract top pharmaceutical companies, clinical research and biomedical manufacturing opportunities abound. Indeed between 2000 and 2015, the number of clinical research programs conducted in Singapore jumped by 30%. Today, six out of the top 10 drugs produced globally... Read More
The Philippines Department of Health is now requiring that most medical devices imported, marketed or manufactured in the archipelago nation be registered with its Food and Drug Administration. The new rules, first telegraphed back in January, are expected to increase costs for... Read More
A Malaysian law requiring companies that manufacture or market medical devices in the country to register with the government goes into full effect this month, six years after it was first passed. The 2012 law was designed to bring Malaysia, which imports... Read More
In March 2018, India’s Department of Pharmaceuticals published guidelines proposing that domestic-made components make up 25 to 50 percent of medical devices procured by the government. The 25 percent requirement would apply to medical electronics, hospital equipment, surgical instruments, and diagnostic reagents/in-vitro... Read More
While China-wide shutdowns for major holidays have significantly decreased in recent years, they still have a big impact on sourcing and manufacturing chains in the United States. Chinese New Year in particular greatly impacts timeframe and quality issues, especially for sensitive medical... Read More
Following the example of the U.S. FDA's Orphan Drug Act established in 1983, some Asian countries have developed orphan drug legislation, such as Singapore's Orphan Drug Exemption to the Medicines Act and Japan's Orphan Drug Amendment to the Pharmaceutical Affairs Law. While... Read More
Introduction Despite its small population of 5.6 million, Singapore is a key drug market for Western pharmaceutical companies. Singapore’s pharmaceutical market is currently estimated to be about $820 million. It is expected to grow at a steady rate of 6% in 2017,... Read More
There are several steps to consider when entering the Asian medical device market. This presentation covers 10 essential steps to help grow your business in Asia. Case studies will be used to demonstrate key points. To view these presentation slides, please click... Read More