China’s Center for Drug Evaluation (CDE) issued new guidelines in late July supporting the use of DCT via telemedicine to allow clinical trials to be done remotely. The DCT guidelines may be implemented as long as investigators and sponsors agree and the... Read More
The MHLW‘s proposed 2024 budget will increase about 12%. Part of this increase will be used to set up a new regulatory consultation group which will focus on expediting pediatric and orphan drugs. This group will also help the MHLW committee in... Read More
While bribery has been significantly reduced in China’s medical market over the last five years, it still exists. For example, there have been significant reductions of payments to NMPA officials for drug approvals. However, in other areas of the Chinese medical system,... Read More
Advanced healthcare is limited in China due to restrictive pricing schemes that reduce payments. Programs like the drug reimbursement list, diagnosis-related groups (DRGs), and Diagnostic Intervention Packets (DIPs) limit reimbursements and thus make expensive new therapies unaffordable in China. To counter these... Read More
On September 9, Laos will implement its first-ever medical device regulations. While in 2011, a registration policy was discussed, medical device registration was not implemented. Laos’ Ministry of Health Food and Drug Department (FDD) has outlined the required registration documents and specific... Read More
Please click here to access the presentation: Vietnam Medical Device Reimbursement Read More
Overview and History Malaysia presents a robust and influential market for foreign medical device and drug companies looking to expand their presence to Southeast Asia. The oversight of medical devices in Malaysia falls under the Medical Device Authority (MDA), which operates as... Read More
China is the second-largest drug market in the world. Registering drugs in China is more accessible today than ever. That does not mean it is easy or straightforward. Before attempting to do so, international drug companies should research the prevalence of the... Read More
History and overview The Health Sciences Authority (HSA) is a government organization in Singapore that falls under the Ministry of Health. The HSA performs three primary roles: it acts as the national regulatory approval authority for all health products, manages the national... Read More
Contact us today for a free consultation with a China regulatory affairs consultant to discuss your specific needs. To register a drug in China, the drug factory must meet China’s GMP standards. China initiated GMP requirements for drugs in 1988 but has revised... Read More