Following quicker approval times for biopharmaceuticals in Korea, the Ministry of Food and Drug Safety (MFDS) will review and plan to expedite registration for innovative medical devices. Various government departments and medical institutions will determine within 30 days if the device meets... Read More
Last month, one of our news briefs discussed remote inspections for medical device GCP. Recently, the PMDA also issued remote GCP inspections for drugs and regenerative products. In August, the Japanese PMDA issued these guidelines in English. These guidelines advise on the... Read More
Indonesia’s Ministry of Health initiated a “Pharmacy and Medical Device Dictionary” which amounts to a public database of drugs and devices in Indonesia. This dictionary is basically a web-based system where each device and drug receives a unique code. To date, there... Read More
For medical device approvals in Japan, the Japanese PMDA must do a GCP compliance inspection of the clinical data with the applicant during a face-to-face meeting. This in-person inspection is normally done in a conference room at the PMDA. On August 24th, an... Read More
On July 27, in an effort to reinforce the management and use of pharmaceutical products in many fields, the National Healthcare Commission (NHC) issued the Notice on Further Strengthening Medication Safety Management and Improving the Level of Rational Medication. This notice put special emphasis on pediatric... Read More
The recent amendments of the Japanese Act on the Protection of Personal Information (AAPI) have implications for healthcare businesses. According to the amendments, companies/health institutions are not allowed to transfer personal data overseas. Transfer of data outside of Japan is only permitted under special circumstances.... Read More
Although Singaporean medical practitioners were allowed to import unregistered medical devices for use on their patients with approval from the HSA, there have not been specific guidelines on this issue until this August. According to this recently issued guideline from the Health... Read More
In order to facilitate the development of new drugs, Japan’s Ministry of Health, Labor, and Welfare (MHLW) is seeking an increased budget for its Orphan Drug Designation program. In order to obtain this designation in Japan, orphan drugs need to fulfill certain... Read More
As mentioned in previous newsletters, foreign drug and device companies can gain quicker access to China’s healthcare markets if they first register their products either on Hainan Island or in the Greater Bay Area. On Hainan Island, hospitals can apply for unregistered... Read More
Last month, Singapore’s HSA provided a draft guideline on LDTs. This guideline stated that LDTs used as IVDs or for RUO are not classified as LDTs. LDTs are tests that are only developed and used by labs at their own sites. Labs... Read More