Quick Asia Regulatory Updates (November 2026)

Japan’s Ministry of Health, Labour and Welfare (MHLW) issued a set of notifications on September 30 to prepare drugmakers for the May 20, 2027 start of new legal rules on risk management plans (RMPs) under the amended Pharmaceuticals and Medical Devices (PMD) Act. Until now, RMPs have been tied to a product’s approval. Under the new system, the law itself will govern when an RMP plan is needed, based on each drug’s actual safety profile. Companies will be expected to write a new RMP, or update an existing one, whenever a new safety issue arises, including for drugs that never had a plan or whose plan has already ended. Drug makers should talk with the Pharmaceuticals and Medical Devices Agency (PMDA) beforehand and notify it when a plan is created, changed, or closed. Plans will no longer automatically come up for review at re-examination. Instead, they can end whenever PMDA concludes they’re no longer needed, and a drug’s electronic label will show whether an RMP is currently in place.

Manufacturers of moderate-risk medical devices in Korea could soon get their products certified in about 25 days instead of roughly 40, under a rule change MFDS put forward in mid-September. Right now, a device company has to wait for a designated review body to finish evaluating its technical file before it can take that report to the National Institute of Medical Device Safety Information (NIDS) and ask for certification. The proposal would let NIDS handle both steps in parallel from a single filing. Companies that prefer the current approach could still use it. Because some Class II products go through full approval rather than certification, manufacturers should check which pathway applies to them first.