China’s State Administration for Market Regulation announced on September 1 new regulations of online drug sales. The regulation will be implemented on December 1 to strengthen and increase oversight. The Measures for the Supervision and Administration of Online Drug Sales includes 6... Read More
On September 13th, the MHLW (Ministry of Health, Labor and Welfare) issued an administrative notice requiring the display of codes (barcode display) on containers to identify medical devices and in-vitro diagnostics. Previously, the display of codes on devices was recommended, but not required. The... Read More
On September 13, India’s Union Health Ministry added 34 drugs to the National List of Essential Medicines (NLEM) and dropped 26 drugs. Newer and better anti-infectives, anti-nicotine replacements, treatments for diabetics, tuberculosis, etc. were added. Older and less effective gastrointestinal drugs and... Read More
International KGMP biopharmaceutical inspections were halted in Korea in early 2021 because of the COVID-19 pandemic. However, in September, the Ministry of Food and Drug Safety (MFDS) announced that they will proceed with these KGMP inspections in 2023. Since there is now... Read More
In August, the Malay Medical Device Authority (MDA) issued a guidance document outlining the Association of Southeast Asian Nations (ASEAN) harmonized list of medical devices. This list includes over 250 devices and also classifies the devices (A, B, C, and D) in... Read More
Following quicker approval times for biopharmaceuticals, the Korean 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 the... 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