This presentation provides an overview of the regulatory framework and drug registration process in India. To view these presentation slides, please click on Drug Registration in India Presentation. Table of Contents: Regulatory Framework in India FDC Registration Process in India... Read More
Asia’s healthcare landscape is changing with its growing middle class. China, India and ASEAN’s middle classes are expected to grow by around 100 million people in the next ten years. Asia’s demand for healthcare will continue to grow with more people able... Read More
In mid-February 2017, India’s National Pharmaceutical Pricing Authority (NPAA) fixed the price of drug eluting stents at $450 and bare metal stents at $110 USD. The NPAA may look to regulate the prices of 14 other medical devices that also have high... Read More
This article was also published on MedTech Intelligence. Government healthcare expenditures in Asian countries has been increasing steadily in recent years. According to a 2016 Deloitte report, the average annual increase in government healthcare spending in Asian countries is more than 6%,... Read More
In late January, 2017, India’s Central Drugs Standard Control Organization (CDSCO) finally released Medical Device Rules, which establish different regulatory norms for medical devices and drugs. For over 10 years, the Indian government has been trying to set up new medical device... Read More
This article was also published on MedTech Intelligence. Regenerative medicine focuses on harnessing the body’s ability to heal itself by restoring the functionality of damaged tissues and organs. Current medicine treats symptoms but oftentimes does not repair the underlying problems, which is... Read More
The Indian drug price regulator, the National Pharmaceutical Pricing Authority (NPPA) proposed in January 2017 to categorize stents into two categories: drug-eluting stents (DES) and bare-metal stents (BMS). Along with this proposal, the NPPA also proposed to fix the prices of these... Read More
Multiple countries in the APAC region have been experiencing outbreaks of preventable diseases in 2016. The number of Singapore’s measles cases doubled in the first half of 2016 compared to the same time period in 2015, while Malaysia’s tripled from 2015 to... Read More
This article was also published on MedTech Intelligence. Historically, Myanmar (known as Burma until 1989) has been isolated from the rest of the world. Recent political changes have, however, opened Myanmar up to the West, stimulating economic growth. In particular, the medical device... Read More
While the US and EU have been using health economics outcomes for drugs and devices for a number of years, Asia is behind in this area. Much of this is caused by the lack of standardized systems, regulations, and resources needed to... Read More