In an effort to streamline its drug approval process, the Chinese government will expedite the review of 48 urgently needed drugs already approved outside of China. Under these eased requirements announced in August, the China National Drug Administration (CNDA) will waive the... Read More
Renewing medical device registrations in China just became more simple. Moving to expedite the introduction of important new technologies to market, regulators announced this summer that they will require less documentation on sales data and post-market inspection reports from device makers seeking... Read More
As the pharmaceutical industry’s expansion into emerging markets meets the desire of Asian governments to speed approval of innovative products, demand for clinical trials is soaring in the Asian region. By 2021, the global market for clinical trials is expected to reach... Read More
Last month, the China National Drug Administration (CNDA), formerly known as the China Food and Drug Administration (CFDA), released a fourth batch of Class II and III medical devices that may be exempted from the requirement to conduct local clinical studies to... Read More
Starting in October 2018, the Korean Ministry of Food and Drug Safety (MFDS) will implement stronger controls on clinical trials done in Korea. Going forward, medical institutions will need to provide more information on possible side effects of a clinical trial. In... Read More
Seeking to encourage drug companies to conduct more clinical trials of innovative medicines in China, the Chinese government has proposed new protections on pharmaceutical data. Under the draft proposal, the China Drug Administration (CDA) would expand data exclusivity—the protection of clinical data... Read More
In a step forward for the advancement of health research in South Korea, patients participating in clinical trials aimed at advancing public health are now covered by the country’s vaunted national health insurance system. The change went into effect on May 1.... Read More
On February 6, 2018, China’s Food and Drug Administration (CFDA) and the Center for Medical Device Evaluation (CMDE) issued a new draft guidance for the approval of medical devices intended to treat rare diseases. The guidelines set out requirements for applicants to... Read More
Over the last few years, the number of clinical trials in India has dropped by 90%. In March 2018, India’s Health Ministry released a comprehensive set of rules for clinical trials that will apply to all new drugs. The rules, covering everything... Read More
Until recently, almost all risky medical devices and in vitro diagnostics (IVDs) were required to conduct local clinical studies in China to be receive registration approval there. In 2017, the China Food and Drug Administration (CFDA) issued guidelines for the acceptance of... Read More