The US FDA has set emphasising the benefits of QbD, traceability and risk based manufacturing facility inspections as strategic priorities for the next four years in document published for consultation this week.
The document covers pharmaceuticals, food products and tobacco and sets of the Food and Drug Administration’s (FDA) regulatory goals though to 2018.
Although it is not particularly detailed the plan does reference several high profile problems that have beset the pharmaceutical industry in recent years and emphasises the role manufacturers must play in ensuring product safety.
“Serious safety and quality lapses in recent years have presented public health challenges, most notably those involving foodborne illness, drug shortages, and unsafe manufacturing practices of compounded sterile drugs.
“New statutory mandates in the FDA Food Safety Modernization Act (FSMA), FDA Safety and Innovation Act (FDASIA), and the Drug Quality and Security Act (DQSA) necessitate that industry and FDA re-think traditional approaches to safety and quality.”
Drug development process
The agency also indicated its desire to make the pharmaceutical development process more straightforward and less expensive by making greater use of new analysis tools during the assessment process.
The FDA said that: “Some stakeholders suggest that current costs of bringing a new medical product to market are a major barrier to investment, including those for uncommon diseases, unmet needs and special populations.”
Again the agency did not go into specifics, but did indicate that increasing its use of modelling technologies and enhancing its communication efforts with sponsors as key goals.
The FDA also said it will try to make the drug review process more transparent, timely and predictable.
“FDA is committed to achieving the long-term goal of improving the exchange, review, and management of information associated with human and animal drug and biologic applications throughout the product life cycle through strategic investments in automated, standards-based IT.”