Sponsors trialling drugs in Asia should insist on the highest manufacturing standards and consider local production to successfully navigate the varied and complex regulations that govern research in the region says Almac.
Clinical trials across Asian countries are soaring, according to Paul O’Connor, Vice President of Global Quality at Almac, due to the need to provide new medicines for their rapidly growing populations and pharma’s desire to access local patients as both trial participants and, eventually, consumers.
However, as this market grows, he told Outsourcing-Pharma.com, pharma firms and CROs face a number of challenges to ensure clinical trial materials are consistently manufactured, stored, handled, transported and distributed in order to adhere to Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP).
“The critical points to monitor have largely become those related to customs and duties,” he said. “GxP documents accompanying shipments may have to be translated, and some countries’ customs officers regularly open shipments without adequate understanding of the material they are handling. This can lead to difficulty with temperature-sensitive products, and even product mix-ups. ”
As for regulations and guidance, they are “well established in some countries, which is particularly helpful when clinical trial material handling is specifically described and included,” he said. “Where it is not, sponsor companies and their contracted organisations must bring their own experiences and best practices to the table.”
From country-to-country, there are also varying degrees of regulations especially relating to Investigational Medicine Products (IMPs) which require companies to use their judgment as to which standards to follow.
However, O’Connor continued, “this is not too concerning, as experienced organisations will naturally gravitate to the higher ground and follow established GMP and GDP norms.”
Furthermore, GMP hurdles can be overcome by implementing a regional manufacturing and packaging strategy, he added, which often removes the need to have multiple manufacturing licences in varying countries.
“Improved shipping components, temperature monitoring solutions and supporting technology and processes have also enabled a much more replicable, timely, and reliable distribution chain.”
O’Connor also spoke of “cross-country networking between regulatory bodies” as key to adhering to GMP/GDP in Asia, citing the alignment of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-
operation Scheme (PIC/S), with documents from regulators including the US FDA, within Asian countries.
“There is further encouraging internationalisation of GMP and GDP standards in the very recent acceptance of South Korea and Japan into PIC/S membership. All of these initiatives are rapidly addressing the many issues associated with managing supplies in Asian markets.”
Finally, he said, change is being driven by globalisation. “Trial data from one territory is used to support submissions in others. That can only occur if the standards employed are above reproach.
“I’m encouraged by the progress we’re seeing, and excited to see how trials conducted within and from the region can help get critically important new drugs to market.”