Over the last 5 years, getting drugs registered in China and available for sale has become more efficient, easier, and a lot quicker. However, China drug pricing is still a major concern. Two drug price reduction schemes are outlined below. First, one... Read More
Hoping to revamp its pharmaceutical landscape, Japan is trying to balance the scales of drug pricing, innovation, and access to cutting-edge medications. These efforts, led by the Ministry of Health, Labour and Welfare (MHLW) and the Drug Pricing Organization (DPO), reflect a... Read More
Japan reduces drug prices every two years or more recently yearly. As announced on March 5 in the MHLW‘s gazette, starting April 1, drug prices will be reduced by about 4.7% for about 13,000 products including 7,000 oral drugs, 3,600 injectables, 2,000... Read More
As mentioned last year in our news brief, China initiated a significant corruption crackdown in 2023. This crackdown was escalated again late last year when China’s National People’s Congress promulgated the 12th amendment to its criminal code. Starting last month (March), penalties... Read More
In Indonesia, the Goods and Services Procurement Policy Agency, is responsible for an e-Catalogue that allows the government to purchase a variety of needed products. This is an online Indonesia government language procurement platform. The e-Catalogue in Indonesia was initially set up... Read More
Most drug and medical device executives know that getting Human Genetic Resources (HGR) from China is not an easy task. However, over the last year, China has implemented changes to make this a somewhat easier process. For example, data can be transferred... Read More
In an effort to improve the Japan drug lag problem, the Japanese government plans to initiate several programs to simplify and optimize its drug clinical trial program. First, there are too many systems for clinical trials in Japan including the PMD Act,... Read More
According to Singapore’s Regulation 23, when a drug company wants to register a new drug, the Health Sciences Authority (HSA) needs to determine if there is a patent in force. According to the Singapore’s Patent Act 1994, the HSA requires the drug... Read More
On March 6, 2024, Malaysia issued Medical Device Exemption Order 2024, superseding the previous Exemption Order from 2016. This regulatory overhaul introduces an expanded framework for the exemption of certain medical devices from the registration mandate under the Medical Device Act 2012. The... Read More
On March 12, the Indian Department of Pharmaceuticals issued a new regulation for drug marketing called the – Uniform Code for Pharmaceutical Marketing Practices (UCPMP). Accordingly, all pharmaceutical associations in India are required to set up Ethics committees for Pharmaceutical Marketing Practices. Each... Read More