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6, 2018, China’s Food and Drug Administration (CFDA) and the Center for Medical Device Evaluation (CMDE) issued a new draft guidance for the approval of medical devices intended to treat rare diseases.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
On January 4, 2018, the China Food and Drug Administration (CFDA) released guidelines for the design of medical device clinical trials. The document covers the basics of clinical trials such as blinding and randomization, and goes into the more specific elements of... Read More
Last year, the China Food and Drug Administration (CFDA) issued draft rules on clinical drug trials aimed at bringing its system more closely in line with international norms. Among the key changes proposed, clinical drug trials will be subject to a 60-day... Read More
The Indian Central Drugs Standard Control Organization (CDSCO) has made it mandatory for global drug clinical trials to include Indian patients for internationally developed drugs. Additionally, global clinical trials that are already approved in ICH (international Council for Harmonization of Technical Requirements... Read More
China regulations for medical registration could be easing soon. On October 8, 2017, new regulations from the State Council were issued. The proposed changes are not yet law. For both drugs and devices, the proposed changes will include: Acceleration of the CFDA... Read More
Following the example of the U.S. FDA's Orphan Drug Act established in 1983, some Asian countries have developed orphan drug legislation, such as Singapore's Orphan Drug Exemption to the Medicines Act and Japan's Orphan Drug Amendment to the Pharmaceutical Affairs Law. While... Read More
China currently has virtually no specific policies or legislation regarding orphan drugs despite having 16.8 million patients with rare diseases, according to the Chinese Center for Disease Control and Prevention. Furthermore, many orphan drugs approved in western countries are unavailable in China.... Read More
Korea has emerged as a leading pharmaceutical market and global hub in Asia over the last two decades. With a population of 50 million, Korea is the third largest pharmaceutical market in the Asia-Pacific region. Market Size and Growth In 2016,... Read More