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
In late October, the NMPA broadcasted the Rules for Applicable Discretion of Administrative Penalties in Drug Supervision and Administration for stakeholders’ feedback. The updated draft applies to medical devices, drugs, and cosmetics and outlines how the Chinese government will gather evidence of... 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
Korea is currently the 10th largest drug market in the world. While in the past, Korean drug companies mostly made generic drugs, today, they are making new chemical and biological products. Korean drug companies and foreign drug companies looking to sell their... 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
On September 18, China’s National Health Commission (NHC) released its second list of rare diseases. This list includes 86 rare diseases including Giant Cell arteritis, Gorlin Syndrome, Fragile X Syndrome, etc. We have posted the complete list. It is estimated that China... 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
While the US and EU follow ICH’s Q12 guidelines for post-marketing drug approval changes, Japan does not. Post-marketing changes in Japan require applications for partial change approval and minor change notifications for low and high-risk changes. In Japan, these take a lot... Read More