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In mid-April, China set forth the bidding results of the 8th national VBP. This program reduced prices by about 50% and affected about 40 drugs. The winning bidders were almost exclusively Chinese drug companies, with only a few foreign companies winning. According... Read More

On March 9, 2023, a new regulation for ensuring cyber security was issued in the Essential Requirements Criteria in Japan. The Essential Requirements Criteria’s Article 12 already had 2 clauses, but clause 3 on cybersecurity has now been added. In short, medical... Read More

Dealing in the Chinese drug data market has never been easy. Western drug companies that are now doing multi-regional clinical studies that include China, and Western drug companies licensing drugs from Chinese originators, oftentimes need China data to be successful with drug... Read More

Normally, drug approval in Japan is based on clinical trials done under Japanese GCP requirements. On the other hand, clinical research not initially used for drug registration is called Specified Clinical Research (SCR). SCR is regulated by the Japanese Clinical Research law.... Read More

Many global health authorities have already adopted eCTD drug submissions. Singapore too plans to implement this system in the fourth quarter of 2024. To ease the use of eCTD in Singapore, the HSA will broadcast an eCTD regulatory guidance over the next... Read More

Up until recently in Japan, most drug applications, informed consent forms, and other drug documents needed to be in hard copy with original personal stamps or signatures. On March 30, Japan’s Ministry of Health, Labor, and Welfare (MHLW) authorized the use of... Read More

In 2020, India promulgated their Medical Device Rules Act. This act increased medical device registration requirements in India. Before the act, only about 35 device categories required registration. After the act, all previous non-regulated devices now need CDSCO approval. Initially, non-regulated Class... Read More

Currently, while digital health is very prevalent in the West, it is still at an infant stage in Japan. However, this is changing now. In 2020, a startup in Japan called Cure Up received regulatory approval for its nicotine addiction treatment. Also,... Read More

Two weeks ago, India’s Union Cabinet, the top decision-making body in India, authorized a new medical device policy to increase its domestic device production. Currently, India only makes about 1% of the world’s medical devices and this new policy aims to increase... Read More