The latest round of negotiations between the Chinese government and pharmaceutical firms has yielded massive price cuts for consumers in the country on more than 65 new brand-name drugs in return for access to the second-largest pharmaceutical market in the world. The... Read More
Driven by the urgent need to speedily combat the COVID-19 epidemic, Japan plans to ease its famously stringent requirements on clinical trials of vaccines and other essential drugs, laying the groundwork for rapid approval when emergency need is deemed to be overwhelming.... Read More
China’s National Medical Products Administration (NMPA) in November announced the creation of a platform to collect information related to all active pharmaceutical ingredients (APIs) in circulation in the country. The new platform will allow NMPA, which drafts laws and regulations for drugs,... Read More
Moving with increasing urgency to encourage the development of drugs to treat rare diseases, Chinese regulators are planning for the first time to authorize real-world studies of orphan drugs. Technical guidelines released in October by the National Medical Products Administration’s Center for... Read More
Spurred by the harmonization of safety requirements on drug development by regulators in the United States and Europe, Japan’s drug regulators are tightening requirements on the development of new pharmaceuticals. By next year, for example, all products used in clinical trials must... Read More
With the COVID-19 pandemic making clear the urgent need to speed approvals and enable flexibility in pricing of innovative biopharmaceutical products, regulators in India have drafted a new set of measures to streamline innovative drug research and development. Released in draft form... Read More
Eager to encourage the development within its own borders of pharmaceuticals to meet urgent health needs of its people, Japan’s health authorities have begun discussions on establishing an emergency approval system modeled on that of the United States. While a legal pathway... Read More
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
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
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