DCAT Week '16: Regulatory Changes GDUFA II and GMP API Inspection Trends: The Business Impact of Upcoming Regulatory Changes

Frances Zipp (Lachman Consultants) briefed the audience on key international regulatory initiatives and highlighted the global focus on data integrity. Citing unprecedented cooperation among international regulatory authorities, Ms Zipp outlined inspection priorities for the European Medicines Agency (EMA), Health Canada, and the Food and Drug Association (FDA). Ms Zipp recommended the audience thoroughly review the International Conference on Harmonisation (ICH) Q7 guidelines for Good Manufacturing Practice. ICH Q11 for Development and Manufacture of Drug Substances was also reviewed and Ms Zipp commented that the material was very high level, leaving manufacturers confused and in need of clarity. ICH Q10, Pharmaceutical Quality Systems, was referred to by Ms Zipp as the bible for supplier oversight on supplier quality management. In closing, Ms Zipp stated the most important points for business and public health boils down to: staying up to date on current regulatory expectations, knowing your suppliers and those that supply them, risk-assessing suppliers, and considering cost versus security/reliability.

The Generic Drug User Fee Act (GDUFA) is due for reauthorization in September 2017. As negotiations for GDUFA II are underway, Terri Nataline (Lachman Consultants) gave a timely address in regard to what aspects of GDUFA have worked, what needs to be improved, and possible upcoming changes. According to Ms Nataline, the FDA Office of Generic Drugs has met all commitments outlined in the GDUFA goal letter but questions remain whether if this is enough for the industry. Application review and approval times are still an issue. Approval metrics are one of the major concerns to be addressed in GDUFA II. The FDA must be able to justify the fees with results. Ms Nataline cited establishment fees as the biggest issue with GDUFA 1. GDUFA II legislation should consider a small establishment exemption as well as who would pay for any fee relief. Ms Nataline could not comment on projected fees for GDUFA II though outlined additional issues to be addressed including increased transparency and consistency regarding review of applications and inspections.

An overview of GMP API inspection trends was provided by Dilcia Granville (US FDA). Ms Granville explained that the increase in warning letters is due to the increase in inspections. Some crucial issues drawing the attention of the agency in its inspection efforts include data integrity, quality risk management, and failure to follow standard operating procedures to adhere to good manufacturing practices.

In light of the FDAs inspection efforts, Robin Kumoluyi (Novartis) discussed best practices to address challenges in supplier management and supplier oversight to optimize external development and manufacturing. Ms Kumoluyi also highlighted data integrity as a top priority for compliance and explained that 8 out of 11 FDA warning letters issued in 2015 had a strong data integrity component. Ms Kumoluyi stressed the importance of knowing your suppliers and where they are to increase supply traceability and mapping of your supply chain. Supplier audit programs are increasingly vital and systems must be in place for supplier qualification of risk assessment.

Learn more about these themes with a new article from BioWorld Today: "Solution to drug prices not as simple as clearing generic backlog." Read about how Thomson Reuters supports Pharma Fine Chemicals & API Manufacturers and Generic Finished Dose Manufacturers & Marketers.