An industry divided
The global pharmaceutical industry can be divided into aligned vs. non-aligned countries. In aligned countries such as Japan, US, Canada and most European Union countries, most companies rigorously follow industry best practices and established standards and maintain a genuine commitment to quality. In aligned countries, when people are trained in the correct processes for doing their jobs, they usually adhere to those practices. But in non-aligned countries, there might be a tendency for people to try to find ways to shortcut the process (“I don’t need to fill out all those forms or follow those procedures. I can get this done quicker.”) They might believe these shortcuts benefit their company because they can create more of a product faster if they skip a few steps. But those steps are built into the process to ensure safety, control quality and enforce traceability that supports defensibility for auditors and inspectors. New mandates established in FDASIA will have a substantial impact on pharmaceutical companies in non-aligned countries, and this has implications for US markets. The vast majority of the generic drugs consumed in the US come from pharmaceutical companies in the Asia-Pacific (APAC) region and other non-aligned countries. The US market can or soon will represent as much as 80 percent of their profits. A significant number of pharmaceutical companies in non-aligned countries will go out of business if they can’t sell their products in the United States. Half of the drugs consumed in the US are used by people over the age of 65 and are paid for by Medicare. The largest integrated healthcare system in North America is the US Veterans Administration (VA). With more than 1,700 hospitals, clinics, community living centres, and other facilities, the VA writes the most prescriptions and dispenses a large percentage of drugs in the US. A major objective of the Affordable Care Act is to lower the cost of health services that the US Government directly
FDASIA dictates that generics and biosimilars companies must now pay user fees to the FDA, and by May 5, 2017 all submissions to the FDA must be made electronically.
funds – including Medicare and the VA–and this initiative is compelling a move toward generics and biosimilars that are often not manufactured in the US. So if Obamacare is to lower the cost of national healthcare in the US, that must be done by a move toward less expensive generic drugs that come from Asia and other non-aligned regions. FDASIA dictates that generics and biosimilars companies must now pay user fees to the FDA, and by May 5, 2017 all submissions to the FDA must be made electronically. The purpose of these policies is to create a more efficient industry and safer products for consumers by streamlining the submission and approval process for new drugs and by generating funds for the FDA to inspect pharmaceutical factories in foreign countries more frequently. Senior management and decision makers in pharmaceutical companies based in non-aligned countries must understand how serious this is. It’s not realistic for them to expect that they can comply with these mandates without investing in their business or changing the way they operate. Data quality and data integrity drive best practices
The Electronic Common Technical Document (eCTD) is an interface used by the pharmaceutical industry to transfer regulatory information to agencies like the FDA. This interface is supported
and enabled by enterprise Document Management Systems (eDMS). Why is it better for companies to have eDMS systems? Some years ago that was the conversation within the industry. We talked about improving return on investment by making processes more efficient and enforcing unified information and standardisation. But today the conversation has changed. Soon companies will not be able to communicate with the FDA without eDMS. They will not be able to make regulatory submissions to the FDA without eCTD publishing software. There are countless business advantages compelling pharmaceutical companies to invest in integrated systems, unified data, end-to-end information flow and standard ways of identifying records across all systems and departments. However, it can be difficult to sell that story into Asia and other nonaligned regions today. Because labor is cheap there, company decision makers often solve problems not with automation, standardised processes and best practices—but with people. In some non-aligned countries, companies don’t care if they need to re-run an experiment or process to restore data that was lost due to poorly integrated or non-existent information systems. They simply dedicate plentiful and inexpensive human resources to solving the problem. Unfortunately, this tactict ends to compromise data quality and data integrity, which can lead to violations in current Good Manufacturing Practices (cGMP). In April 2016 the FDA issued new guidance for the pharmaceutical industry to clarify the role of data integrity in cGMP for drugs. The regulator drafted the guidance because its inspections were increasingly revealing cGMP violations due to poor data integrity. Throwing more manpower at issues like process duplication, siloed information and other common challenges doesn’t truly solve problems. Companies that do this may have found a shortcut, loophole or a quick way around an issue. But that doesn’t help the industry move toward www.pharmafocusasia.com