Giving goes a long way, and lately, industry and regulators seem to be more open to giving out information. FDA and EMA recently released an update about their joint pilot programs. One pilot, which ran December 2008 to December 2010 and involved FDA, EMA, the European Directorate for the Quality of Medicines, and the Australian Therapeutic Goods Agency, focused on sharing surveillance lists about API manufacturing sites. The shared reports influenced agency decisions about inspections and imports. The second pilot involved FDA and EMA and focused on good clinical practice. The two agencies exchanged more than 250 documents relating to 54 drug products and organized 13 collaborative inspections of clinical trials.
Reports on the joint pilot programs note that continued collaboration will require innovative tools that allow for real-time information exchange. These tools could help the agencies avoid duplication of efforts. Said FDA’s Deborah Autor about the programs via a press release, “It is imperative that FDA work closely with its counterparts in order to ensure the safety and quality of products and the integrity of clinical trials. We cannot do it alone.”
Industry seems to have come to the same conclusion. Rx-360, the international pharmaceutical supply-chain consortium, has been promoting the idea of shared audits for a few years now. In 2011, a few companies completed audits as part of the consortium’s own pilot program. Avantor (formerly Mallinckrodt Baker), for example, participated in the pilot and has written about its experience in the August Outsourcing issue of PharmTech.
“The audit was beneficial because it allowed Avantor to view its manufacturing processes through a lens that combined most industry audit standards into one comprehensive and stringent audit,” wrote Avantor. The end goal of Rx-360’s program is to amass a repository of audits for the industry to share so that manufacturers can reduce the number of individual audits they have to perform. Reducing individual audits based on shared data can be a huge money-saver considering that regulators expect manufacturers to audit every single supplier, contract organization, and distributor in their supply chain.
Giving up ownership of something can be difficult, but it seems that industry is beginning to realize the benefits of collaboration. Let’s hope it continues.