In the past, Malaysia has not had any medical device regulations, including product registration. In March 2012, Malaysia’s Ministry of Health (MOH) cleared legislation for two acts that will establish a new regulatory agency for medical devices and require mandatory registration of... Read More
The Japanese government plans to adopt a “compassionate use” system, which will allow patients to use medical treatments not yet approved in Japan. This system will be made available to patients diagnosed with advanced diseases that are not responsive to existing domestic... Read More
The Korean Food and Drug Administration (KFDA) is in the process of changing its pre-approval system. The plan is to implement the new system partially within this year. The KFDA has presented a draft regulation of this change. Under the proposed new... Read More
The Singapore Health Sciences Authority (HSA) released an announcement that QMS requirements for Class A medical devices have been reduced. Essentially, all that is required now is a signed Declaration of Conformity. Foreign device companies have complained about the difficulty of fulfilling... Read More
The Indonesian pharmaceutical market was estimated to be around US$4 billion in 2011. The countrys pharmaceutical market has been steadily growing. Along with increased domestic demand, sales of prescription drugs are expected to grow approximately 12% in 2012, according to IMS Health... Read More
With a population of close to 90 million, Vietnam has one of the least-developed pharmaceutical markets in Asia, with relatively low per capita spending on drugs. However, there is significant growth potential in the country. While Vietnam's healthcare industry is still developing,... Read More
The Philippines pharmaceutical market is growing rapidly. It is heavily driven by imports and is currently the third largest market in ASEAN after Indonesia and Thailand. The Philippines pharmaceutical market, currently valued at about $3.0 billion, is predicated to reach about $3.4... Read More
Although still heavily reliant on drug imports, Thailand's domestic pharmaceutical market is steadily growing. The Thai pharmaceutical market is currently valued at about $4.3 billion. The Thai generic sector is expanding as the government is encouraging the use of generic drugs over... Read More
The Malaysian drug market, currently valued at about $1.6 billion, is still relatively small but grown quickly. The pharmaceutical market is set to grow at about 7% between 2012 and 2014. Original branded drug sales, through retail pharmacies, comprised over 15% of... Read More
China’s State Food and Drug Administration (SFDA) is planning to start a new drug GMP inspection program. Under the pilot program, officials from SFDA’s GMP department will visit a total of 10 overseas manufacturing facilities, concentrating on vaccines, biologics, and active pharmaceutical... Read More