In April 2016, the China Food and Drug Administration (CFDA) released a set of guidelines that regulatory officials should follow when inspecting medical device production facilities. The checklist provides inspectors with a comprehensive list of specific elements they should investigate including personnel,... Read More
On March 4, 2016, the China Food and Drug Administration (CFDA) launched and enacted the Work Plan for Reforming Chemical Drugs Registration Classification System (the New Classification). The new classification redefines generics and new drugs and classifies them into five categories: Category... Read More
China’s State Council General Office recently released a statement declaring that locally produced generic drugs should have the same quality and efficacy as similar brand-name drugs. After conducting tests, China’s Food and Drug Administration (CFDA) will publicize the names of the medicines... Read More
In February 2016, South Korean lawmakers passed an amendment that allows the National Health Insurance Service (NHIS) to collect damages from pharmaceutical and medical device companies that violated data reporting guidelines. Under this new amendment, the NHIS can collect insurance losses from... Read More
For years, Taiwan’s Ministry of Health and Welfare (MOHW) has been debating whether to implement an alternative healthcare payment plan known as the Taiwan diagnosis-related group payment system (Tw-DRG). The system, modeled after the DRG system used in the United States, classifies... 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
In an effort to curb the over-prescription of antibiotics, the Indian government will alter the packaging on certain medicines to differentiate them from other drugs. A red vertical line will be added to antibiotic packaging in order to spread mass awareness against... Read More
In February 2016, the Malaysia Medical Device Authority (MDA) released a set of guidelines that will help medical device manufacturers comply with Malaysia’s regulations. The guidelines will support manufacturers as they complete the Declaration of Conformity, a legal document drawn up by... Read More
In March 2016, the Medical Device Authority of Malaysia (MDA) issued a draft of the “Code of Advertisement for Medical Devices” to provide guidance “in ensuring good marketing practices and advertising messages which promote the quality use of medical devices in a... Read More
In a statement released on February 26, 2016, the China Food and Drug Administration (CFDA) announced that it would accelerate the approval process for certain new medicines. These new medicines will treat high priority diseases including AIDS, viral hepatitis, and illnesses that... Read More