Global battle to defend API supply chain

As the manufacture of PHARMACEUTICALs and preparations worldwide grows, regulators are putting increasing pressure on pharmaceutical companies to ensure that all products entering the pharmaceutical supply chain meet the necessary safety and quality requirementsIn fact, the consequences of some unexpected events in the pharmaceutical industry have attracted wide spread of public attention, and it is necessary to increase safety awareness of the global drug supply chainGovernments and regulators have adopted and implemented measures through regulations and voluntary programmes aimed at avoiding a repeat of past problemsWhile these initiatives have placed particular emphasis on the development of pharmaceuticals or related raw materials (e.gaccessories), there are other measures for API that will have the most direct impact on API manufacturersfTw
United States: Additional resources and processesfTwIn the United States, the Medicine quality and safety act (DQSA), signed by obsioPresident Ma on November 27, 2013, becomes law, and the Act will greatly affect drug manufacturers, most notably, the requirement seeking to identify and track specific drug prescriptions sold in the United States in Chapter II of DQSAThe U.SFood and Drug Administration (FDA) has management responsibilities through other procedures established by DQSAWhile DQSA does not directly affect API manufacturers, John DiLoreto, executive director of the APIF Working Group (BPTF) of the Association of Chemical Manufacturers and Affiliates of the United States, said: "It is gratifying to see that GMP certification is expandingWe recognize that any drug safety issue can affect the entire pharmaceutical industry, with a negative impact on all members of the supply chainfTwFDA is also actively developing guidelines, as well as other materials related to the FDA Safety and Innovation Act (FDASIA), which was signed into law on July 9, 2012Most relevant to the global drug supply chain is FDASIA Chapter VII, which includes provisions that penalize companies that provide drugs of suspicious origin to the FDA, including delaying, refusing, restricting or refusing to check, and imposing fines for adulteration and counterfeiting fTw
　　FDASIA also gives the FDA the power to establish mechanisms for faster approval of drugs for serious or life-threatening diseases and to collect royalties (such as prescription drugs, generics, biosimilars and medical devices) from various sectors of pharmaceutical companies to finance reviews of innovative drugs, medical devices, generics, biosimilars and biological products, and inspections at international production facilities fTw
　　The BPTF particularly encourages this development because it has been working closely with members of Congress, FDA staff and industry leaders to address the FDA's lack of resources to conduct GMP inspections by foreign drug manufacturers "Pharmaceutical companies are eager to see the FDA step up inspections of foreign production sites, which not only enhances the safety of the API supply chain, but also provides a level playing field for the investment programs and processes that pharmaceutical companies have already made to ensure the safety and quality of their products," said John DiLoreto John DiLoreto said he was pleased that the FDA has partnered with the Chinese government to establish a testing protocol in China similar to that used by domestic companies in the United States In fact, Section 705 of FDASIA requires the FDA to conduct biennial drug inspections at drug production facilities at home and abroad in a risk-based investigation Inspection standards include establishing a compliance history and inherent risks of producing drugs The Agency is currently developing a risk-based approach to inspectiontor to reflect regulatory standards and is working to establish common risk principles in conjunction with the centres the global battle for the protection of THE API supply chain
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as the global manufacture of API and preparation as the global API and preparation manufacturing to ensure that all products entering the pharmaceutical supply chain must meet the necessary safety and quality requirements, regulators are putting increasing pressure on pharmaceutical companies In fact, the consequences of some unexpected events in the pharmaceutical industry have attracted wide spread of public attention, and it is necessary to increase safety awareness of the global drug supply chain Governments and regulators have adopted and implemented measures through regulations and voluntary programmes aimed at avoiding a repeat of past problems While these initiatives have placed particular emphasis on the development of pharmaceuticals or related raw materials (e.g accessories), there are other measures for API that will have the most direct impact on API manufacturers fTw
　　United States: Additional resources and processes fTw In the United States, the Medicine quality and safety act (DQSA), signed by obsioPresident Ma on November 27, 2013, becomes law, and the Act will greatly affect drug manufacturers, most notably, the requirement seeking to identify and track specific drug prescriptions sold in the United States in Chapter II of DQSA The U.S Food and Drug Administration (FDA) has management responsibilities through other procedures established by DQSA While DQSA does not directly affect API manufacturers, John DiLoreto, executive director of the APIF Working Group (BPTF) of the Association of Chemical Manufacturers and Affiliates of the United States, said: "It is gratifying to see that GMP certification is expanding We recognize that any drug safety issue can affect the entire pharmaceutical industry, with a negative impact on all members of the supply chain fTw FDA is also actively developing guidelines, as well as other materials related to the FDA Safety and Innovation Act (FDASIA), which was signed into law on July 9, 2012 Most relevant to the global drug supply chain is FDASIA Chapter VII, which includes provisions that penalize companies that provide drugs of suspicious origin to the FDA, including delaying, refusing, restricting or refusing to check, and imposing fines for adulteration and counterfeiting fTw
　　FDASIA also gives the FDA the power to establish mechanisms for faster approval of drugs for serious or life-threatening diseases and to collect royalties (such as prescription drugs, generics, biosimilars and medical devices) from various sectors of pharmaceutical companies to finance reviews of innovative drugs, medical devices, generics, biosimilars and biological products, and inspections at international production facilities fTw
　　The BPTF particularly encourages this development because it has been working closely with members of Congress, FDA staff and industry leaders to address the FDA's lack of resources to conduct GMP inspections by foreign drug manufacturers "Pharmaceutical companies are eager to see the FDA step up inspections of foreign production sites, which not only enhances the safety of the API supply chain, but also provides a level playing field for the investment programs and processes that pharmaceutical companies have already made to ensure the safety and quality of their products," said John DiLoreto John DiLoreto said he was pleased that the FDA has partnered with the Chinese government to establish a testing protocol in China similar to that used by domestic companies in the United States In fact, Section 705 of FDASIA requires the FDA to conduct biennial drug inspections at drug production facilities at home and abroad in a risk-based investigation Inspection standards include establishing a compliance history and inherent risks of producing drugs The Agency is currently developing a risk-based approach to inspectiontor to reflect regulatory standards and is working to establish common risk principles in conjunction with the centres