By Matt Lowe
How Drug Companies Can Meet Two Key Regulations With Cloud Technology
While already overseeing the world’s second-largest pharmaceutical market, China’s State Administration for Market Supervision (SAMS) officials have made evident their plans to actively promote faster entry of international drugs into the Chinese market and correspondingly expand the availability of Chinese drugs in global markets. They’re also aiming to establish the nation as an important innovator of drug products. This is a far cry from an industry sector that even Bi Jingquan, the director of what was formerly known as the China Food and Drug Administration (CFDA), once acknowledged “had a late start and a weak basis.”i
China is now the fastest-growing pharmaceutical market — one that experts believe will become the top prescription drug market in the next seven to 10 yearsii — and recent regulatory initiatives signify that the nation is positioning itself to become the world’s pre-eminent pharmaceutical superpower.
China’s National Medical Products Administration (NMPA), the division of SAMS formerly identified as the CFDA that regulates and establishes standards for life sciences products, continues to bring its regulatory policies for drug manufacturing into closer alignment with global Good Manufacturing Practice (GMP) regulations. These evolving regulatory guidelines are profoundly influencing the way China-focused life sciences companies establish and use computerized systems in their manufacturing operations. A recently announced traceability initiative will also have a dramatic impact on China’s life sciences sector by formalizing the way companies will be required to use electronic systems to manage and track drug information and product serialization.
This white paper provides an overview of the essential aspects of recent regulatory guidelines that the NMPA has issued to advise companies in the use of electronic systems for quality management, traceability and product serialization as they do business in China’s life sciences marketplace. It will also offer suggestions on how companies can leverage cloud technology to effectively and efficiently meet these regulatory expectations while also strengthening the integrity of the data they manage and maintain during the course of manufacturing and supplying drug products.