Recently, the Malaysian government has been trying to implement stricter regulatory control of imported pharmaceutical products. Beginning July 2012, all drugs imported into Malaysia will be required to undergo a strict licensing scheme before entering the country. Companies who wish to import... Read More
Singapore’s Health Sciences Authority (HSA) and Malaysia’s National Pharmaceutical Control Bureau (NPCB), the pharmaceutical regulatory body within the Malay Ministry of Health (MOH) recently signed a memorandum of understanding (MOU) on pharmaceutical regulatory matters. This is the first health sector MOU signed... Read More
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 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
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
The Malaysian government recently announced seven new entry point projects (EPPs) in the healthcare industry. The new EPPs are part of a government initiative to attract global medical device companies to the country and to increase Malaysia’s role as a major player... 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
Malaysia will soon introduce its Medical Devices Act by the end of 2011. This Act is expected to be established when the current Medical Devices Bill 2008 is presented to the Malaysian Parliament either at the end of March 2011 or in... Read More
With some of the highest levels of national healthcare spending in Asia (ranking third after Vietnam and South Korea), Malaysia is taking hold of its strategic strengths in the pharmaceuticals and medtech sectors, among others, to expand the country’s economic growth. The... Read More
The Association of Malaysia Medical Industries (AMMI) is lobbying the government to change how the state affects the industry. Currently, the Malaysian government influences the medical device market by providing financial incentives for investments in R&D. AMMI, however, believes that the government... Read More