A few months ago, a number of Chinese organizations including the Ministry of Public Safety, the Ministry of Industry and Information and Technology, the Ministry of Science and Technology, and the Cyberspace Administration outlined interim measures on the field of AI. These... Read More
Last month, PBM’s newsletter outlined how Hong Kong is becoming more advanced in clinical research. On October 31, Hong Kong’s Pharmacy and Poisons Board was allocated “observer status” with the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use... Read More
1. Overview The Central Drugs Standard Control Organization (CDSCO) functions as India’s primary regulatory authority overseeing pharmaceuticals, medical devices, and cosmetics. The CDSCO is also responsible for supervising the Drugs Consultative Committee (DCC), the Drugs Technical Advisory Board (DTAB), and the Central... Read More
1. Overview The Ministry of Health, also referred to as Departemen Kesehatan, is the governmental entity responsible for executing health policies. It is headed by the Minister of Health, who reports directly to the Indonesian President. The National Agency of Drug and... Read More
1. Overview The Thai Food and Drug Administration (Thai FDA) is responsible for safeguarding the well-being of consumers, particularly by guaranteeing the safety, quality, and effectiveness of various health products under its jurisdiction. Important matters are determined by committees comprised of experts... Read More
1. Overview Established in 1945, the Ministry of Health (MoH) in Vietnam is a government agency tasked with overseeing and managing various aspects of public health and healthcare products. This includes pharmaceuticals, medical devices, preventive medicine, medical care and treatment, rehabilitation, traditional... Read More
In October, Singapore plans on starting a 90-day trial to determine the cybersecurity risk of medical devices. This is a joint effort between Singapore’s MOH, the Cyber Security Agency and the National Health Technology Agency (Synapxe). The fear is that some devices... Read More
As noted in our July newsletter, the Indian authorities required all non-notified Class C and D devices to be registered by October 1. Such devices could include certain X-ray products, ventilators, etc. that have moderate to high risks. However, some medical device... Read More
Overview of the MFDS The Ministry of Food and Drug Safety (MFDS), formerly recognized as the Korean FDA, is the regulatory authority responsible for overseeing safety matters related to a wide range of products, including drugs, medical devices, food, functional food, and... Read More
To learn more about how we can help you obtain a DMF in Korea, please contact us. According to the Korean MFDS, all APIs used for medicinal products that require pharmaceutical equivalence should be registered as DMFs in Korea. For the DMF... Read More