Which country has the lowest pass rate for FDA overseas drug inspections?
Last Update: 2020-06-17
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, June 10 (Xinhua) -- The FDA released its testimony at a U.Scongressional hearing last week on the FDA's overseas drug production inspection proceduresThe speakers were senior FDA officials, including Deputy Director of Regulation, Deputy Director of Global Policy and Strategy, and Deputy Director of the CDER Regulatory ProgramHere's an excerpt:the globalization of the pharmaceutical industry
theof an increasingly globalenterprise over the past 30 yearsBeginning 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 environmentalregulations
are often weaker than in 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 EuropeIn its 2011 report, "Access to Global Product Safety and Quality," the FDA 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.Sdrugmarket shifts to low-cost generics, producers 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.Smanufacturing plants for API and 46 percent of the plants producing human-made final formulations (FDFs) are located in the U.S(see chart below)the movement accelerated in the 2000s, but the FDA's inspection scant remains focused on domestic production due to the statutory requirements for domestic inspections every two years and limited staffingPrior to the passage of the Food and Drug Administration's Safety and Innovation Act (FDASIA) in 2012, the FDA was required to inspect U.Sproduction facilities every two years, but there was no similar authorization for the frequency of inspections at overseas facilitiesThis has led to frequent inspections of domestic facilitiesThe FDAthe globalization of drug inspection programs
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 productsIn addition to increasing overseas inspections, our efforts include: , developing new enforcement and regulatory tools
and strengthening cooperation with overseas regulatory agencies and other stakeholders
developing internationally harmonized standards and convergence of standards Introducing FDA requirements to overseas industries, as well as , improving supply chain transparency and accountability
and establishing overseas offices in China, India, Europe and Latin America, and having offices overseas The FDA's drug-screening program shifted from a focus in the early 2000s on facilities in the United States to a program that has conducted more overseas tests since 2015 than at home See figure: chart: FDA inspections of overseas drug manufacturing facilities have increased dramatically since 2006, surpassing inspections of domestic drug facilities since 2015
THE FDA's drug inspection program is now risk-based The FDA based on specific criteria identified, giving priority to inspection facilities that are considered to be at high risk 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 the plant on import alert to prevent potential lying products from entering the U.S market To review the site selection model
the FDA implemented a risk-based approach to drug facility supervision and inspection in 2005 to meet the need to prioritize the use of limited resources 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 With the 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 percent of these previously uninspected facilities (see figure below); has removed another 361 facilities from the catalog (37 percent) because they are no longer part of the FDA's inspection obligations for a variety of reasons, for example, they are closed, are not served in the U.S market, or have been misregistered in the U.S., and , 52 percent or 5 percent of the facilities have been denied inspections, FDA investigators were unable to use 34 of the facilities, or 4 percent, because they could not travel (for example, due to travel warning s); The FDA has now evaluated all previously "never-inspected" facilities
after an inspection of a production facility, the FDA classifies the inspection as "No Action" (NAI), "Voluntary Action" (VAI) or "Directed Official Action" (OAI) · No action (NAI): indicates that no objectionable conditions or practices (e.g quality issues) were found during the inspection (or minor issues are not sufficient for further regulatory measures) · 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 measures · Direct ingenuity (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 factories that did not inspect frequently, as in domestic factories, before FDASIA and GDUFA were established It is important to note that these inspections are usually carried out in advance by prior notification of the facility's overseas inspections (pre-announced) 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) Figure Most of the final results of the production plants for the production of human-made medicines are acceptable, which means that they are classified as "inaction" or "no voluntary action" However, India's percentage of acceptable results is lower than in other countries and regions (These are the results as of May 2020 for the latest inspection of facilities in the FDA catalog.) FDA encourage industry to adopt advanced manufacturing technologies
in addition to the maturity of quality management, the FDA also 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 an interruption or stop between different processing steps 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 precise control through modern automation and control systems, and can be closely monitored using highly sensitive analytical tools during production Other examples of advanced manufacturing include 3D printing, isolation technology, miniaturization, and robotics Ref.: (FDA) (FDA) (2020-06-02) COVID-19 and Beyond-of-the-FDA's Foreign Drug Manufacturing Inspection Process - 06/02/2020
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