Moving to improve the safety of clinical trials, China’s Center for Drug Evaluation (CDE) has drafted new regulations on the timing, duration, and manner in which such trials are conducted. Under the new regulations, clinical trials would need to be initiated within... Read More
China’s National Medical Products Administration (NMPA) is seeking public comments on new regulations it is drafting on drug registration, drug distribution, and manufacturing. The new regulations, updated in October by the Ministry of Justice, reflect changes made to the Drug Administration Law... Read More
Malaysia’s Medical Device Authority in October revised its requirements for the labeling of medical devices. Under the new guidelines, devices must be labeled with a Malaysian medical device registration number within six months from their date of registration. Medical devices for home... Read More
Regulations on in-vitro diagnostic (IVD) medical devices expected to go into effect in 2020 in South Korea will establish a broad set of registration requirements for IVDs as part of a push to improve oversight of their safety and quality, according to... Read More
One year after Japan tightened its drug pricing system in a bid to make cutting-edge treatments more affordable, the restrictions threaten to slow drug sales to the country, a pharmaceutical industry leader warned last month. Under the new policy, announced in 2018,... Read More
Moving to bring regulatory order to its growing medical device industry and market, the Indian government has begun drafting quality and efficacy standards that would cover all medical devices sold in the country. The effort by India’s Central Drugs Standard Control Organization... Read More
Moving to make it easier for innovative drug therapies to enter the Chinese market, the country’s National Healthcare Security Administration (NHSA) announced in August 2019 it will make 148 new drugs eligible for insurance reimbursement. Altogether, patients will be able to seek... Read More
Six months after Collategene became the first gene therapeutic drug cleared for use in Japan, the country’s health insurance system announced in September 2019 it would be placed on the list of pharmaceuticals approved for coverage. The drug, which introduces genes that... Read More
Stymied by what they say is overzealous regulation, India’s’ drug companies are increasingly lobbying the government to reduce oversight of clinical trials, ease limits on new pharmaceutical ventures, and reduce regulations on new drugs. Pharma firms in India are big business. Currently... Read More
Seeking to ease access among patients in Singapore to urgently needed life-saving therapies, the Health Sciences Authority (HSA) in September 2019 announced a faster route to the approval of such critical imports. Under the new regulations, licensed hospitals or clinics, retail pharmacies,... Read More