Put simply, the Medical Device Single Audit Program (MDSAP) isn't going anywhere when its pilot project ends in 2016, Kim Trautman, associate director, international affairs of the Office of the Center Director of CDRH at the US Food and Drug Administration (FDA), told attendees of RAPS' Regulatory Convergence on Wednesday. MDSAP is the international consortium of five regulators from the US, Australia, Japan (which came on board in June), Brazil and Canada looking to tr...

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Details New Approach to Medical Device GMP in Four Guidance Documents China Food and Drug Administration (CFDA) has moved to strengthen its oversight of medical device manufacturing. The new approach is detailed in four guidance documents covering medical device good manufacturing practices (GMPs), in which CFDA explains its approach to on-site inspections. CFDA...

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Sets Terms for State Regulatory Investment Plan The Indian Ministry of Health has set the terms under which it will distribute the Rs 850 crore ($129 million) state regulatory investment package. States signing up to the memorandum of understanding (MoU) will only continue to receive funding if they achieve certain predefined goals. Ministry of Health officials ha...

Australian and New Zealand officials have confirmed they plan to stop development of the Australia New Zealand Therapeutics Products Agency ( ANZTPA ), a joint regulatory authority meant to more efficiently regulate healthcare products in both countries. Background The ANZTPA has been under development since at least 2011, and had reached several notable milestones since 2012. In September 2012, it put out a call to  harmonize over-the-counter drug regulations , and  co...

This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. The Australian government has announced that experts will review the Therapeutic Goods Administration’s (TGA) framework for the regulation of medicines and medical devices. According to a 24 October 2014 announcement by Health Minister Peter Dutton and Assistant Minist...

This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. Australia’s Therapeutic Goods Administration (TGA) this week (15 September 2014) issued  an amended guidance on nonclinical studies for Module 4 of the  Common Technical Document  (CTD), which is an integral part of an application to register a prescription medicine on...