China’s State Council is ordering the China Food and Drug Administration, and other agencies, to implement stricter policies to reform the country’s regulation of drug prices, GMP compliance and pharmaceutical…

The drug and device industries must be prepared for sweeping changes to the status quo promised by the 21st Century Cures Act, according to one expert. Source: Drug Industry Daily

In its latest biennial report to Congress on high-risk government programs, the GAO downgraded its rating of the FDA’s action plans, saying CDER, CBER and CDRH’s long-term strategies lack adequate…

The FDA issued warning letters to four overseas manufacturers over GMP and other failures. Source: Drug Industry Daily

The EMA completed all inspections and scientific advice procedures on time and met its performance targets in the first half of 2016 even as GMP inspection requests and orphan designation…

Novartis and the Association for Accessible Medicines, formerly known as GPhA, are criticizing the FDA for underestimating the effect that using random suffixes to identify biologics and biosimilars will have…

PhRMA called on the U.S. trade representative to assess threats and barriers to intellectual property in 18 countries, and to focus in particular on China, India, Colombia, and Canada. Source:…

The EMA revised Q&A guidance on pharmacovigilance fees, clarifying which sponsors and assessments are subject to charges. Source: Drug Industry Daily

Three senators urged newly confirmed secretary of HHS, Tom Price, to fast track the importation of certain prescription drugs from Canada following “significant or unexplained” increases in U.S. prices. Source:…

The number of trials in the European Medicines Agency’s electronic database of post-authorization studies topped 1,000 this month. Source: Drug Industry Daily