The Experts below are selected from a list of 3051 Experts worldwide ranked by ideXlab platform
Tim Reed - One of the best experts on this subject based on the ideXlab platform.
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Reshaping the carcinogenic risk assessment of medicines: International Harmonisation for drug safety, industry/regulator efficiency or both?
Social Science & Medicine, 2003Co-Authors: John Abraham, Tim ReedAbstract:The most significant institutional entity involved in the Harmonisation of drug testing standards worldwide is the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), which comprises the three pharmaceutical industry associations and regulatory agencies of the EU, US and Japan. It is often claimed that such Harmonisation will both accelerate the development and approval of new drugs and preserve safety standards, if not strengthen safety regimes. Drawing on extensive documentary research and interviews, this paper systematically examines whether the efforts by the ICH to improve industrial and regulatory efficiency by harmonising drug testing requirements is likely to raise, maintain or compromise safety standards in carcinogenic risk assessment of pharmaceuticals. The evidence suggests that, in the field of carcinogenicity testing, the ICH management of International Harmonisation of medicines regulation is not achieving simultaneous improvements in safety standards and acceleration of drug development. Rather, the latter is being achieved at the expense of the former. Indeed, the ICH may be converting permissive regulatory practices of the past into new scientific standards for the future. These findings are significant as many expert scientific advisers to drug regulatory agencies seem to have accepted uncritically the conclusions reached by the ICH, which may affect a potential patient population of half a billion and tens of thousands of clinical trials.
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reshaping the carcinogenic risk assessment of medicines International Harmonisation for drug safety industry regulator efficiency or both
Social Science & Medicine, 2003Co-Authors: John Abraham, Tim ReedAbstract:The most significant institutional entity involved in the Harmonisation of drug testing standards worldwide is the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), which comprises the three pharmaceutical industry associations and regulatory agencies of the EU, US and Japan. It is often claimed that such Harmonisation will both accelerate the development and approval of new drugs and preserve safety standards, if not strengthen safety regimes. Drawing on extensive documentary research and interviews, this paper systematically examines whether the efforts by the ICH to improve industrial and regulatory efficiency by harmonising drug testing requirements is likely to raise, maintain or compromise safety standards in carcinogenic risk assessment of pharmaceuticals. The evidence suggests that, in the field of carcinogenicity testing, the ICH management of International Harmonisation of medicines regulation is not achieving simultaneous improvements in safety standards and acceleration of drug development. Rather, the latter is being achieved at the expense of the former. Indeed, the ICH may be converting permissive regulatory practices of the past into new scientific standards for the future. These findings are significant as many expert scientific advisers to drug regulatory agencies seem to have accepted uncritically the conclusions reached by the ICH, which may affect a potential patient population of half a billion and tens of thousands of clinical trials.
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trading risks for markets the International Harmonisation of pharmaceuticals regulation
Health Risk & Society, 2001Co-Authors: John Abraham, Tim ReedAbstract:Drawing on interviews and documentary research, this paper explores the nature of International Harmonisation of pharmaceutical regulation. The relationships between International Harmonisation, trade interests in market expansion and the regulatory state are examined. Particular attention is given to the implications of this Harmonisation for drug safety, risk assessment and public health. It is argued that this process is lowering regulatory standards regarding drug safety and is making the regulatory state more vulnerable to capture by industrial interests. This is accentuated by the misrepresentation of societal and political judgements as technical calculations and a concomitant lack of public accountability.
John Abraham - One of the best experts on this subject based on the ideXlab platform.
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Reshaping the carcinogenic risk assessment of medicines: International Harmonisation for drug safety, industry/regulator efficiency or both?
Social Science & Medicine, 2003Co-Authors: John Abraham, Tim ReedAbstract:The most significant institutional entity involved in the Harmonisation of drug testing standards worldwide is the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), which comprises the three pharmaceutical industry associations and regulatory agencies of the EU, US and Japan. It is often claimed that such Harmonisation will both accelerate the development and approval of new drugs and preserve safety standards, if not strengthen safety regimes. Drawing on extensive documentary research and interviews, this paper systematically examines whether the efforts by the ICH to improve industrial and regulatory efficiency by harmonising drug testing requirements is likely to raise, maintain or compromise safety standards in carcinogenic risk assessment of pharmaceuticals. The evidence suggests that, in the field of carcinogenicity testing, the ICH management of International Harmonisation of medicines regulation is not achieving simultaneous improvements in safety standards and acceleration of drug development. Rather, the latter is being achieved at the expense of the former. Indeed, the ICH may be converting permissive regulatory practices of the past into new scientific standards for the future. These findings are significant as many expert scientific advisers to drug regulatory agencies seem to have accepted uncritically the conclusions reached by the ICH, which may affect a potential patient population of half a billion and tens of thousands of clinical trials.
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reshaping the carcinogenic risk assessment of medicines International Harmonisation for drug safety industry regulator efficiency or both
Social Science & Medicine, 2003Co-Authors: John Abraham, Tim ReedAbstract:The most significant institutional entity involved in the Harmonisation of drug testing standards worldwide is the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), which comprises the three pharmaceutical industry associations and regulatory agencies of the EU, US and Japan. It is often claimed that such Harmonisation will both accelerate the development and approval of new drugs and preserve safety standards, if not strengthen safety regimes. Drawing on extensive documentary research and interviews, this paper systematically examines whether the efforts by the ICH to improve industrial and regulatory efficiency by harmonising drug testing requirements is likely to raise, maintain or compromise safety standards in carcinogenic risk assessment of pharmaceuticals. The evidence suggests that, in the field of carcinogenicity testing, the ICH management of International Harmonisation of medicines regulation is not achieving simultaneous improvements in safety standards and acceleration of drug development. Rather, the latter is being achieved at the expense of the former. Indeed, the ICH may be converting permissive regulatory practices of the past into new scientific standards for the future. These findings are significant as many expert scientific advisers to drug regulatory agencies seem to have accepted uncritically the conclusions reached by the ICH, which may affect a potential patient population of half a billion and tens of thousands of clinical trials.
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trading risks for markets the International Harmonisation of pharmaceuticals regulation
Health Risk & Society, 2001Co-Authors: John Abraham, Tim ReedAbstract:Drawing on interviews and documentary research, this paper explores the nature of International Harmonisation of pharmaceutical regulation. The relationships between International Harmonisation, trade interests in market expansion and the regulatory state are examined. Particular attention is given to the implications of this Harmonisation for drug safety, risk assessment and public health. It is argued that this process is lowering regulatory standards regarding drug safety and is making the regulatory state more vulnerable to capture by industrial interests. This is accentuated by the misrepresentation of societal and political judgements as technical calculations and a concomitant lack of public accountability.
Agnes Artiges - One of the best experts on this subject based on the ideXlab platform.
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the role of pharmacopoeias in International Harmonisation
Journal of Pharmaceutical and Biomedical Analysis, 2001Co-Authors: Agnes ArtigesAbstract:Abstract The last 30 years have seen profound changes in the organisation of the European people and the regulation of medicinal products. Thirty years ago, each country had its own regulations, with all the possible variations between the various national pharmacopoeias. Today, the European Pharmacopoeia, with its 1500 monographs and nearly 250 general methods of analysis, has replaced the major part of these national regulations: the European Pharmacopoeia Convention has now been signed by 27 states 1 and by the Commission of the European Communities; moreover 16 European and non-European countries 2 and the WHO have observer status. Close relations are maintained with the licensing authorities of the European Economic Area, where integration is developing via the implementation of common directives and guidelines on medicines for human and veterinary use. In addition, in 1990, the European Pharmacopoeia co-founded, with the Japanese Pharmacopoeia and the US Pharmacopoeia, the Pharmacopoeial Discussion Group (PDG); this group is working assiduously for Harmonisation at world level.
Lars Ekman - One of the best experts on this subject based on the ideXlab platform.
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The International Harmonisation of guidelines in the future: a viewpoint from the industry.
Toxicology Letters, 1998Co-Authors: Lars EkmanAbstract:In the area of safety, 10 completely new toxicology guidelines have been produced up to 1997 under the umbrella of the ICH. Surveys on the use and impact of the ICH guidelines in the pharmaceutical industry in three regions, Europe, the USA and Japan, showed that approximately 80% of the guidelines were utilised and, as expected, the guidelines which had been in place longest were the ones most often used. The work on the different guidelines has initiated a number of specific investigations such as studies on the duration of dosing of male rats to detect adverse effects on male fertility and the duration of chronic toxicity studies in non-rodents. Evaluation of data from various databases on long-term carcinogenicity studies showed that the mouse studies had had very little influence on the outcome of the regulatory decision about the human carcinogenic risk of a specific compound. An important role for the ICH organisation in the future should be to see that changes and amendments to current guidelines are made as soon as they are warranted by the progress of toxicological science. The decision to accept the Common Technical Document as an official ICH topic is important for the industry and will help the industry to reduce the period between drug discovery and regulatory acceptance. In the area of safety there are still topics which could benefit from Harmonisation. Such topics are safety pharmacology, clinical pathology, immunotoxicology, juvenile toxicity studies, statistical methods in certain types of toxicity studies, and recommendations for additional short- to medium-term carcinogenicity studies.
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The International Harmonisation of guidelines in the future: A viewpoint from the industry
Toxicology Letters, 1998Co-Authors: Lars EkmanAbstract:In the area of safety, 10 completely new toxicology guidelines have been produced up to 1997 under the umbrella of the ICH. Surveys on the use and impact of the ICH guidelines in the pharmaceutical industry in three regions, Europe, the USA and Japan, showed that approximately 80% of the guidelines were utilised and, as expected, the guidelines which had been in place longest were the ones most often used. The work on the different guidelines has initiated a number of specific investigations such as studies on the duration of dosing of male rats to detect adverse effects on male fertility and the duration of chronic toxicity studies in non-rodents. Evaluation of data from various databases on long-term carcinogenicity studies showed that the mouse studies had had very little influence on the outcome of the regulatory decision about the human carcinogenic risk of a specific compound. An important role for the ICH organisation in the future should be to see that changes and amendments to current guidelines are made as soon as they are warranted by the progress of toxicological science. The decision to accept the Common Technical Document as an official ICH topic is important for the industry and will help the industry to reduce the period between drug discovery and regulatory acceptance. In the area of safety there are still topics which could benefit from Harmonisation. Such topics are safety pharmacology, clinical pathology, immunotoxicology, juvenile toxicity studies, statistical methods in certain types of toxicity studies, and recommendations for additional short- to medium-term carcinogenicity studies. Copyright (C) 1998 Elsevier Science Ireland Ltd. All rights reserved.
Tomoko Osawa - One of the best experts on this subject based on the ideXlab platform.
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implementation of the latest scientific knowledge technologies and activities for International Harmonisation of the japanese pharmacopoeia
Yakugaku Zasshi-journal of The Pharmaceutical Society of Japan, 2020Co-Authors: Tsuyoshi Ando, Tomoko OsawaAbstract:The Japanese Pharmacopoeia (JP) is an official document that defines the specifications, criteria, and standard test methods necessary to properly ensure the quality of medicines in Japan. To ensure the efficacy and safety of pharmaceutical products, it is essential to establish standards that ensure their quality. For this purpose, the JP aims to include all drugs that are important from the viewpoint of healthcare and medical treatment, and description of each monograph of medicine is maintained and improved so that those standards can be generally practiced. In addition, to play a key role as the official document in the field of pharmaceutical product quality, JP contents are enhanced by proactively introducing the latest scientific knowledge and technologies. As the International manufacturing of pharmaceutical products and their raw materials that are distributed in Japan is increasing, the JP has recently begun to promote the International Harmonisation of pharmaceutical excipients and general tests through the Pharmacopoeial Discussion Group (PDG) and to swiftly implement the harmonised items in the JP. In addition, the JP will implement Internationally harmonised concepts and specifications for pharmaceutical products, e.g., the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), to define the latest concepts of quality control for pharmaceutical products in the official document. We introduce the implementation of the latest scientific knowledge, technologies, and activities for International Harmonisation of the JP.
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Implementation of the Latest Scientific Knowledge/Technologies and Activities for International Harmonisation of the Japanese Pharmacopoeia
Yakugaku Zasshi-journal of The Pharmaceutical Society of Japan, 2020Co-Authors: Tsuyoshi Ando, Tomoko OsawaAbstract:The Japanese Pharmacopoeia (JP) is an official document that defines the specifications, criteria, and standard test methods necessary to properly ensure the quality of medicines in Japan. To ensure the efficacy and safety of pharmaceutical products, it is essential to establish standards that ensure their quality. For this purpose, the JP aims to include all drugs that are important from the viewpoint of healthcare and medical treatment, and description of each monograph of medicine is maintained and improved so that those standards can be generally practiced. In addition, to play a key role as the official document in the field of pharmaceutical product quality, JP contents are enhanced by proactively introducing the latest scientific knowledge and technologies. As the International manufacturing of pharmaceutical products and their raw materials that are distributed in Japan is increasing, the JP has recently begun to promote the International Harmonisation of pharmaceutical excipients and general tests through the Pharmacopoeial Discussion Group (PDG) and to swiftly implement the harmonised items in the JP. In addition, the JP will implement Internationally harmonised concepts and specifications for pharmaceutical products, e.g., the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), to define the latest concepts of quality control for pharmaceutical products in the official document. We introduce the implementation of the latest scientific knowledge, technologies, and activities for International Harmonisation of the JP.