International – Evolving Global Regulatory Landscape, Strategies and Best Practices

October feature articles reported on a number of timely issues facing regulatory professionals today, including the advantages of using periodic safety update reports, practical solutions to pharmaceutical labeling challenges and best practices and strategies to manage global projects. Experts discussed a process to reform the medicinal products authorization system in China, illustrated the
the need for regulatory requirements for ‘herbasimilars’ and introduced readers to an unknown drug safety advocate.

China Regulations

“Bundling review” is a regulatory procedure specific to China in support of the Chinese government’s goal to reform the medicinal products authorization system. Senior regulatory consultant, Yingying Liu, describes the bundling review process, aimed at simplifying and speeding up the review of new drugs with previously approved active pharmaceutical ingredients, excipients and primary packaging materials. In “Bundling Review for Active Pharmaceutical Ingredients, Excipients and Primary Packaging Materials in China,” Liu translates information contained in several annual regulatory updates to the 2015 guidance, highlighting some of the responsibilities of manufacturers and marketing authorization applicants under the new process…