Clinical data required for drug registration in Indonesia typically includes information on the drug’s safety, efficacy, pharmacology, toxicology, and clinical trials conducted in compliance with Indonesian regulations. This data should demonstrate the drug’s quality and suitability for use in the Indonesian population,... Read More
In Korea, it is not possible to register multiple medical devices under a single application. Each medical device must undergo a separate registration process, necessitating distinct evaluations and documentation to ensure compliance with safety and efficacy standards. Combining multiple devices into one... Read More
At a very high-level, the process for medical device registration in China involves submitting an application to the National Medical Products Administration (NMPA), conducting local testing and possibly local clinical trials, and finally, receiving approval. It is a complex and lengthy procedure... Read More
The time it takes to get a drug approved in Japan can vary, but on average, it may take around 1 to 2 years for priority drugs and 2 to 3 years for standard drugs. This timeframe includes clinical trials, regulatory reviews,... Read More
Japan’s drug approval process is overseen by the Pharmaceuticals and Medical Devices Agency (PMDA). This regulatory body is responsible for evaluating and approving pharmaceuticals and medical devices, ensuring their safety and efficacy in the Japanese market. The PMDA plays a crucial role... Read More
At a very high level, the process for drug registration in Japan involves the submission of extensive documentation, including preclinical and clinical data, to the Pharmaceuticals and Medical Devices Agency (PMDA). PMDA evaluates the safety and efficacy of the drug, and if... Read More
A Japanese Drug Master File (DMF) is crucial because it provides confidential information about the manufacturing, quality, testing, and safety of pharmaceutical ingredients for either APIs, excipients, or drug packaging materials to the Japanese regulatory authorities. This enables pharmaceutical companies to seek... Read More
To submit a Drug Master File (DMF) in China, you must prepare a comprehensive application package in accordance with Chinese regulatory requirements, including administrative information, detailed drug component information, quality data, manufacturing processes, stability data, safety information, change control information, and container... Read More
China’s Good Manufacturing Practice (GMP) for Drugs consists of rigorous quality control standards covering facility infrastructure, quality management systems, personnel training, raw material sourcing, production processes, quality testing, packaging, and record-keeping. Adherence to these comprehensive regulations ensures the safety, efficacy, and quality... Read More
China’s Drug Master File (DMF) system serves as a mechanism for pharmaceutical companies to confidentially submit documentation detailing the quality, safety, and efficacy of their drug ingredients to regulatory authorities. DMF’s are only applicable to APIs, excipients, and drug packaging material. A... Read More