The 2008 PDA/FDA conference opened this morning in Washington, DC, with keynote speaker and CDER’s top dog, Janet Woodcock. The theme of the plenary, “globalization through regulatory harmonization” is a must in today’s pharmaceutical industry.
“Heparin was a wakeup call,” demonstrating that we “need vigilance throughout the supply chain,” she explained. Woodcock added that solving these issues is “going to take a lot of harmonization” given the challenges present. These challenges, she said, include: an explosion of global manufacturing, increased complexity of the supply chain, greater potential for exploitation, a global regulatory system that is still fragmented, US erosion of inspectional coverage, and a lack of modern IT systems.
We all know that FDA’s resources are slim in comparison to the demands placed upon the agency. Even though FDA continues to increase the number of inspections it carries out each year, its global coverage is on the decline because of the number of new sites entering the market. Therefore, every part of industry must hold up to its own responsibilities in this growing supply chain in order to create a “worldwide safety net,” said Woodcock.
Manufacturers, for example, must take responsibility for pharmaceutical quality of their products and for the integrity of their own supply chains. Regulators must adopt standards that ensure a safety net and take actions against poor quality, while enabling continuous improvement. Standards and technical organizations need to reach consensus on technical standards. Professional and technical societies must develop and update standards and disseminate them to industry via educational opportunities.
Woodcock said FDA is trying to do its part by continuing with the Pharmaceutical Quality for the 21st Century initiative, intensifying its international outreach with programs such as Beyond our Borders, and by keeping track of inventory of manufacturing establishments and movement of product. More efforts may crystallize after the upcoming presidential election, alluded Woodcock, such as the FDA Globalization Act and other legislation currently circulating within Congress.
Plenary speakers representing Shanghai’s FDA and the EMEA had similar messages for the PDA/FDA audience. Both Tang Minhao, deputy director of the Shanghai Municipal Food and Drug Administration, and Emer Cooke, head of EMEA’s inspections sector, presented action plans that include broader international reach and greater collaboration with other regulatory bodies. Minhao pointed out that although China is not quite at the “peak” of the mountain for regulatory standards, it is en route and plans to meet the US at the top soon. He said China is doing this by creating more transparency, more effective administrative resources, and additional harmonization concepts.
With the US, European, and Chinese authorities all seemingly on the same page at today’s plenary session, industry should feel a sense of optimism as harmonization efforts continue. But only time will tell how effective harmonization efforts will be—hard work and commitment to implementation (and change) will be required amongst all parties.