Moving to modernize and standardize regulatory review of documentation from pharmaceutical manufacturers, Chinese regulators are launching a pathway to submit pharmaceutical applications, supplements, and reports to authorities using the electronic Common Technical Document (eCTD). The Center for Drug Evaluation of the National... Read More
Five years after Malaysia’s Medical Device Authority (MDA) made it mandatory for foreign manufacturers to register their medical device products to access the country’s market, the authorizations are expiring, but regulators have yet to make it possible for many to be renewed.... Read More
To ensure that equipment used to analyze in vitro diagnostic (IVD) tests meet Singapore’s current standards for health and safety, regulators in October issued guidance to manufacturers clarifying how best to adhere to the requirements. The Health Sciences Authority (HSA) guidance, designed... Read More
Prescription drugs, cosmetics, food supplements, and over-the-counter medicines sold in Indonesia will be required to bear state of the art identification systems under regulations being finalized by the country’s regulatory authority, the National Agency of Drug and Food Control (BADAN POM). By... Read More
In its latest move to better control the safety of medical devices for sale in India, regulators announced in September that a range of devices used in hospitals will be classified into six separate areas for the purpose of assessment and registration.... Read More
A working group established in April by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) is tackling the knotty issues of how best to employ real-world data (RWD) in formulating regulations of orphan drugs and other novel treatments under development for patient populations... Read More
Racing to keep up with the challenges of a fast-expanding biotech sector, China’s regulators are beginning to erect guardrails on how startups can develop, test, and register new drugs. Since September, the National Medical Products Administration (NMPA) has issued more than 15... Read More
With the use of clinical decision support software (CDSS) proliferating among medical providers, Singapore’s HSA has issued guidance on which types of the software technology are subject to the country’s increasingly strict regulations. The HSA guidance is informational and does not impose... Read More
Harnessing new technologies to better evaluate the efficacy of new drugs, regulators in China are beginning to incorporate data, videos, and photos drawn from monitors worn by patients who agree to the use of the information. The country’s Center for Drug Evaluation... Read More
Japan’s health agencies in September released a set of goals for encouraging the development of life-saving drugs, speeding clinical trials, and encouraging medical research and technological advances. Developed by the Ministry of Health, Labor, and Welfare (MHLW), the strategy document, the Pharma... Read More