For many years, India’s clinical trials have been under international scrutiny. India’s global clinical trials have had many problems, such as unethical treatment of subjects, failure to compensate patients for serious adverse events, and lack of adherence to India’s clinical trial regulations... Read More
Vietnam’s National Assembly recently approved a new Pharmacy Law that will be fully implemented in 2017. It will eliminate the country’s current clinical trial requirement for drugs, along with other changes. Currently, Vietnam’s clinical trial requirement has led to a shortage of... Read More
After extreme scrutiny in the global market, the India CDSCO has begun to align India’s regulations with international standards. Previously, drugs and medical devices in India were both regulated under the Drugs and Cosmetics Act of 1940. After failing to amend the... Read More
In June 2016, China implemented a new digital system to record medical data. This system would transform China’s medical sector by allowing health professionals and researchers to have access to a unified system of big data. This system includes data from clinical... Read More
Asia contains some of the world’s largest and fastest growing medical device and pharmaceutical markets in the world. The large and diverse populations found in the Asian countries makes the region an increasingly popular destination for clinical studies. There have been important... Read More
Last year, the China Food and Drug Administration (CFDA) issued a number of regulations for drug clinical trials. This year, the CFDA is continuing its long-term regulatory overhaul by improving medical device regulations. In May 2016, the CFDA released three documents that... Read More
The in vitro diagnostics (IVD) market in China is growing very quickly. In China, the China Food and Drug Administration (CFDA) is the main agency that oversees drugs, medical devices, and IVDs. However, there is currently no formal IVD consultation process in... Read More
In an effort to ensure quality and safety for both multinational and domestic medical devices, the Chinese Food and Drug Administration (CFDA) and the National Health and Family Planning Commission (NHFPC) have jointly published updated guidelines on medical device clinical trial supervision... Read More
On May 19, 2015, the China Food and Drug Administration (CFDA) posted details of the requirements for Clinical Evaluation Reports (CERS). The guidance is applicable for the evaluation of Class II and III devices for registration in China. The key issue is... Read More
According to The Japan Times, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) will revise the regulations concerning clinical trials beginning early next year. Under the new regulations, patients suffering from certain types of cancer or other incurable diseases will be allowed to... Read More