The Malaysian National Pharmaceutical Control Bureau (NPCB) regulates the registration and authorization of manufacturing site changes for pharmaceutical production. There are five types of manufacturing site changes. Type I: Change of manufacturing site within Malaysia As a result of upgrading of facilities... Read More
From June 2003, registrations of new pharmaceutical products in Malaysia can be done online. The Malaysian government, through the National Pharmaceutical Control Bureau (NPCB) has established a comprehensive online registration system which allows manufacturers, license holders, and resellers of pharmaceutical products to... Read More
Many regulatory authorities in Asian countries are choosing to allow medical device product registration submissions to be done in electronic form. Previously, all governments required product registration applications to be completed in paper form, however, technical advances and the advent of a... Read More
Despite the slowing economies, Asia still continues to offer medical device manufacturers many investment opportunities. With information and updates on China, Malaysia, Thailand, the Philippines and ASEAN, this article highlights the benefits and advantages of manufacturing medical devices in Asia. Asian countries... Read More
As Asian countries begin to adopt more western lifestyles and foods, “western” diseases are becoming more prevalent killers in Asia. Economic transition, urbanization, and technological development have brought about lifestyle changes that have increased the chances for heart disease in Asia. Developing... Read More
Malaysia reported medical-related products exports of RM 1 billion (US$0.26 billion) in the first six months of 2002. Much of these exports include rubber surgical gloves, dental and surgical instruments, electro-medical and x-ray equipment, needles, catheters and syringes. The Malaysian government wishes... Read More
A recent report by the accounting firm, Ernst & Young, finds an increase in the amount of investment by governments in the Asia-Pacific region in biotechnology. Besides investment incentives and tax breaks, governments have begun to nurture the fledgling industry with increased... Read More
The Drug Control Authority (DCA) is the regulatory agency charged with regulating pharmaceutical products in Malaysia. Established under the Control of Drugs and Cosmetic Regulation 1984 (CDCR), the DCA’s main task is to ensure the quality, safety, and efficacy of pharmaceutical and... Read More
Malaysia’s Drug Control Authority (DCA), which was established under the Control of Drugs and Cosmetics Regulations 1984, is a government authority that ensures the safety, effectiveness and quality of cosmetic products marketed in Malaysia. The DCA is responsible for the registration and... Read More
The pharmaceutical industry in Malaysia is currently valued at more than US$300 million and is growing at an average annual rate of ten percent. By 2005, it is expected to account for 45.9 percent of the entire healthcare industry, or US$539.47 million... Read More