FDA Overseas Drug Inspection Which Country Has the lowest pass rate?

Last week, the FDA released its testimony at a congressional hearing on the agency's procedures for overseas drug production inspectionsThe speakers were senior FDA officials, including Deputy Director of Regulation, Deputy Director of Global Policy and Strategy, and Deputy Director of the CDER Regulatory ProgramOver the past 30 years, the pharmaceutical industry has become an increasingly global enterpriseBeginning in the 1970s, industry shifted from the Continental United States to Puerto Rico in response to tax incentives, and then to Europe and countries that were developing at the time, such as China and Indiadeveloping countries can save significant costs to pharmaceutical companies because of their low labour, energy and transport costsIn addition, their environmental regulations are generally weakcompared to those of developed countriesA World Bank study estimates that China and India had a cost advantage of about 40 per cent in 2004 compared with the United States and EuropeFDA report, "Access to Global Product Safety and Quality," also noted that both China and India enjoy labor cost advantages, and that the production of active pharmaceutical ingredients (APIs) in India can reduce costs by about 30 to 40 percent for U.Sand European companiesas the U.Sdrug market shifts to low-cost generics, manufacturers are under increasing cost pressure and are finding that these efficiencies urgently need to locate more facilities overseas, especially in developing parts of the worldThis shift is reflected in the Center for Drug Evaluation and Research (CDER) site catalog ("Catalog") that lists all drug production facilities worldwide that are subject to routine FDA inspectionsas of May 2020, 26 percent of u.Splants for API production and 46 percent of the plants producing human-made final formulations (FDF) are located in the U.S(see chart below)the movement accelerated in the 2000s, but because of the legal requirements for domestic inspections every two years and limited staffing, the FDA's inspector general sits on domestic productionlaw required the FDA to inspect U.S manufacturing facilities every two years before the Food and Drug Administration's Safety and Innovation Act (FDASIA) was passed in 2012, but there was no similar authorization for the frequency of inspections at overseas facilities This has led to frequent inspections of domestic facilities in response to the shift from domestic to global production and the adoption of FDASIA, the FDA has developed and implemented a comprehensive strategy to promote better coordination and oversight of medical products In addition to increasing overseas inspections, our efforts include develop new enforcement and regulatory tools
strengthen cooperation with overseas regulators and other stakeholders
develop internationally harmonized standards and convergence of standards
introduce FDA requirements to overseas industries, and to increase transparency and accountability in our supply chains
establish overseas offices in China, India, Europe and Latin America, and have offices overseas the FDA's drug-screening program shifted from a u.S facility in the early 2000s to a program that has conducted more overseas tests since 2015 than at home See figure below: FDA's drug screening program is now risk-based The FDA prioritizes inspection facilities that are considered to be at high risk, based on specific criteria identified the FDA did so when it determined that a surprise inspection was required Over the past few years, FDA researchers have conducted unannounced inspections of overseas production plants, including in India and China when major problems are identified at overseas production plants, the FDA uses other tools to protect patients, including placing factories on import alerts to prevent potential lying products from entering the U.S market to meet the need to prioritize the use of limited resources, the FDA implemented a risk-based approach to drug facility supervision and inspection in 2005 A mathematical model, the Site Selection Model (SSM), is designed to select facilities that do not meet established production quality standards and have the greatest public health risks The FDA uses the results of the model to prepare a priority list of facilities to be inspected new resources, the FDA will be able to inspect certain facilities that have not been inspected before As of December 2016, 963 overseas production plants that had never been inspected by the FDA had been scheduled, according to the catalog By the end of fiscal 2019: FDA has inspected 496, or about 52% of these previously uninspected facilities (see chart below); removed another 361 facilities from the catalog (37%) because they are no longer part of the FDA's inspection obligations for a variety of reasons, for example, they are closed and not in the United States Market services, or misregistered in the United States; , 52 or 5 percent of facilities refuse to check; FDA investigators are unable to use 34 of the facilities, or 4 percent, because they cannot travel (e.g due to travel warnings); and 20 (or 2 percent) of medicines that are not imported into the United States After an inspection of a production facility, the FDA classifies the inspection as "No Action" (NAI), "Voluntary Action" (VAI), or "Indicating Official Action" (OAI) did not direct any action (NAI): indicating that no objectionable conditions or practices (e.g quality issues) were found during the inspection (or minor issues, not sufficient for further regulatory measures) Indicates Voluntary Action (VAI): refers to the discovery of objectionable conditions or practices, but the FDA is not prepared to take or recommend any administrative or regulatory action Directive Official Action (OAI): means that regulatory and/or administrative measures will be recommended not surprisingly, since 2012, inspections of high-risk facilities have become more frequent, and the FDA has identified more defects, especially in overseas plants that did not inspect as often as domestic plants, before FDASIA and GDUFA were established note, these inspections are usually overseas (pre-announced) of the facility in advance The results show that the final resultof (NAI or VAI) for all countries except India is 90% or higher, which is acceptable (see figure below) In addition to the maturity of quality management, the FDA encourages pharmaceutical companies to invest in advanced production technologies to improve their products and processes Despite the widespread use of advanced technologies in other industries such as automotive, aerospace and semiconductors, pharmaceutical companies are now starting to use advanced production technologies new technologies include "continuous production" (CM), in which the finished drug, or active pharmaceutical ingredient, is produced in the form of a continuous stream, unlike traditional mass production, where there is a break or stop between different processing steps in traditional mass production In some examples of advanced drug production, it can be continuously produced from the chemical synthesis of active ingredients to the production of tablets or other dosage forms Product quality can be precisely controlled through modern automation and control systems, and can be closely monitored in the production process using highly sensitive analytical tools Other examples of advanced manufacturing include 3D printing, isolation technology, miniaturization, and robotics