On February 20th, 2012, Mr. Yin Li began his work as the new chief of The State Food and Drug Administration (SFDA). Mr. Yin Li is replacing the former chief, Mr. Ming Li Shao. Since 2006, Mr. Yin Li has worked in... Read More
The Asia-Pacific Economic Cooperation (APEC) group recently declared a goal to align regulatory processes for medical devices and pharmaceutical products by 2020. APEC consists of 21 countries, including the US, China, Australia, and South Korea. The initiative is called the “Strategic Framework... Read More
China's pharmaceutical market is currently the ninth largest worldwide and worth approximately $25 billion. With analysts predicting this market to be the fifth largest by 2013, one cannot ignore China's potential. This webcast will provide an overview of drug registration in China... Read More
On November 12, 2011, the United States and eight other countries jointly announced the outline for a new Trans-Pacific Partnership (TPP) on trade and investment. This landmark partnership aims to coordinate economic activity, regulatory standards, and tariffs in all trade areas. In... Read More
Japan’s Pharmaceuticals & Medical Device Agency (PMDA) has continued to take steps to speed up its review process for new medical devices and pharmaceuticals. Japan is often far slower than places such as the US and the EU in approving medical devices... Read More
The Vietnam medical device market is growing very quickly. To succeed there, foreign medical device companies need to understand the Vietnamese regulatory system and how to get product approval. Read More
With the U.S. and European business climates in a downturn, the world is leaning toward Asia for growth. Tremendous opportunities abound in the China, Japanese, and Indian medical markets. Understanding how to enter, expand or deal with key regulatory issues in these... Read More
Registration of medical devices is not yet required by the Malaysian Ministry of Health. However, the Malaysian government is reviewing the Medical Devices Bill in September, 2011 and Parliament is expected to pass the Bill. If passed, new medical device regulations would... Read More
Singapore passed the Health Products Act in February 2007. This Act has been implemented in stages throughout the past few years. Under this Act, all Class A-D products require Singapore medical device registration with the Singapore HSA. Also, manufacturers, dealers, importers and... Read More
In July 2011, the Department of Pharmaceuticals (DoP) has proposed to create the National Authority of Drugs and Therapeutics (NADT). This proposal aims to integrate the offices of the Drug Controller General of India (DCGI), the Central Drugs Standard Control Organization (CDSCO),... Read More