Seeking to stem confusion among drug and medical device manufacturers, China’s regulatory authorities in July released a draft set of rules clarifying how to register products combining both medical devices and pharmaceuticals in the country. The draft Guidelines for the Registration Review... Read More
For the first time, regulators in Japan are carrying out surprise inspections at facilities where pharmaceutical and medical device products are manufactured. The inspections, which began in August, are designed to improve Japan’s system for ensuring the products are consistently produced according... Read More
Signs are emerging that China will tighten its policies governing clinical trials of drugs produced in the country, part of a series of moves to bolster the study of the safety and effectiveness of pharmaceuticals and to bring them fully in line... Read More
Chinese biotechnology firms have lagged behind their competitors for years in the use of artificial intelligence technologies. But increasingly, regulatory reforms are making it easier and cheaper for pharmaceutical companies in China to harness a vast trove of data collected from Chinese... Read More
Seeking to topple long-standing obstacles to drug innovation in Japan, pharmaceutical industry leaders in the country have outlined a slate of steps they propose the government take to foster research and development of new products, trim regulations and approval times, and speed... Read More
Philippines authorities are considering setting price caps on a broad array of innovative drug products marketed in the country for the treatment of cancer, diabetes, and cardiovascular disease. Prices of the pharmaceuticals, sold mainly by foreign manufacturers, have been rising rapidly over... Read More
Three major groups representing pharmaceutical companies doing business in Japan are pushing back publicly at what they call plans by regulators to impose onerous new price controls and regulations that would make it harder for them to bring much-needed drugs to market, ... Read More
Continuing to strengthen China’s oversight of the manufacture, import, and distribution of pharmaceuticals, the country’s health regulators in May published a series of measures medical institutions will be required to follow in prescribing and utilizing drugs to treat cancer. The measures released... Read More
With cancer a leading cause of death in Japan, the market for pharmaceuticals to treat tumors is expected to grow by 5% by 2023, and to represent one fifth of the market for pharmaceuticals by 2026. The prediction is part of a... Read More
The new edition of the Japanese Pharmacopoeia, the official compendium of medicines approved by the government for use in the country, will include 33 new pharmaceuticals, among them antibiotics, excipients, and biologics, as well as many unrefined drugs. Inclusion in the Pharmacopoeia... Read More