In late 2016, Korea’s Ministry of Food and Drug Safety (MFDS) announced a revision draft for medical device clinical trials. Key revisions to the regulations include: For pilot clinical trials, the MFDS has eliminated the need to calculate the number of subjects... Read More
Between 2010-2014, Japan’s Pharmaceutical and Medical Devices Agency (PMDA) has been decreasing review times for Class II and Class III pre-market devices. The current Collaboration Plan to Accelerate Review of Medical Devices will implement the following faster timelines by 2018: New devices:... Read More
The China Food and Drug Administration (CFDA) has released technical guidance on clinical trials, which outlines the entire clinical trial process for drug developers. The guide provides a comprehensive overview of the drug development process, including fundamental ethical principles and more detailed... Read More
Late last year, the US and China held their 27th annual Joint Commission on Commerce and Trade (JCCT) meetings in Washington, DC. The US and China are the world’s two largest economies and are key trading partners. China has the second largest... Read More
In June 2016, the National Assembly of Vietnam updated the Law on Pharmacy, which will take effect on January 1, 2017. This version replaces the current one, which was passed in 2005 and aims to keep Vietnam’s pharmaceutical laws in line with... Read More
On September 30, 2016, the China Food and Drug Administration (CFDA) published an update to “Exemption list of Class II and Class III devices for local clinical study”. Following the May 2016 release of the original list, there are now a total... Read More
In India, 90% of clinical trials over the past few years have ended abruptly primarily due to contract research organizations (CROs) and drug companies using Indian patients as “guinea pigs”. Despite this dramatic slowdown in clinical trials, the Indian government is taking... Read More
As part of an effort to simplify its requirements for clinical trials, Singapore is streamlining its regulations for imported medical device products used in clinical trials. These new regulations were announced in July 2016 and will go into force November 1, 2016.... Read More
On August 24, 2016 the CFDA published a notice on clinical trial fraud. The eight clauses of the notice define clinical trial fraud, explain how responsibility is apportioned, give opportunities for offenders to withdraw fraudulent data, and lay out the consequences for... Read More
Recently, the CFDA published a new draft of the Provisions for Drug Registration for public comment. The new provisions updated the document from the 2007 version by changing Market Authorization Holder (MAH) regulations, improving the application approval process, and lessening provincial level... Read More