Resistance risk evaluation, "a European regulatory perspective"

被引:2
|
作者
Leonard, PK [1 ]
机构
[1] Cyanamid Int, B-5030 Gembloux, Belgium
关键词
D O I
10.1016/S0261-2194(00)00118-6
中图分类号
S3 [农学(农艺学)];
学科分类号
0901 ;
摘要
The European Union directive 91/414 on the inclusion of new and existing active substances requires an assessment of the potential risk of resistance being developed by target organisms and for management strategies to be introduced to address such risks. The European and Mediterranean Plant Protection Organisation (EPPO) worked with regulatory authorities and industry's Global Crop Protection Federation's (GCPF) Resistance Action Committees to develop a guideline that would satisfy these requirements. The new resistance risk analysis guideline was published in April 2000. Implementation of this guideline will force significant changes in the way crop protection products are developed. Applicants for registration of crop protection products will need to evaluate resistance risk and develop acceptable use patterns early in the development process. Registration applications for uses that are associated with an unacceptable resistance risk may be refused. In such cases, restriction or modification of supported use patterns to achieve acceptable levels of resistance risk, could result in use patterns which are no longer consistent with other elements of the registration dossier. It is therefore essential that resistance risk is evaluated early in development so that registration dossiers may be developed with this criteria in mind. (C) 2000 Elsevier Science Ltd. All rights reserved.
引用
收藏
页码:905 / 909
页数:5
相关论文
共 50 条
  • [31] Patient-Focused Benefit-Risk Analysis to Inform Regulatory Decisions: The European Union Perspective
    Muehlbacher, Axel C.
    Juhnke, Christin
    Beyer, Andrea R.
    Garner, Sarah
    VALUE IN HEALTH, 2016, 19 (06) : 734 - 740
  • [32] Evaluation of orphan maintained biological medicinal products in the European Union between 2018 to 2023: a regulatory perspective
    Caferra, Paolo
    Fraisse, Thomas
    Trincavelli, Maria Letizia
    Marchetti, Laura
    Piras, Anna Maria
    EXPERT OPINION ON BIOLOGICAL THERAPY, 2024, 24 (11) : 1279 - 1297
  • [33] Guidelines and global risk: a European perspective
    Wood, D
    EUROPEAN HEART JOURNAL SUPPLEMENTS, 2002, 4 (0F) : F12 - F18
  • [34] REGULATORY ISSUES IN RISK MANAGEMENT - A CALIFORNIA PERSPECTIVE
    LERCARI, FA
    ABSTRACTS OF PAPERS OF THE AMERICAN CHEMICAL SOCIETY, 1991, 202 : 21 - CHAS
  • [35] REGULATORY OVERSIGHT AND RISK ASSESSMENT - A STATE PERSPECTIVE
    JONES, T
    ABSTRACTS OF PAPERS OF THE AMERICAN CHEMICAL SOCIETY, 1990, 199 : 141 - AGRO
  • [36] An Attribute Perspective on Regulatory Regimes in Risk Governance
    Langoy, Morten A.
    Braut, Geir Sverre
    EUROPEAN JOURNAL OF RISK REGULATION, 2024, 15 (03) : 656 - 664
  • [37] STATISTICAL EVALUATION OF GROWTH PROMOTANTS - A REGULATORY PERSPECTIVE
    CONDON, RJ
    BIOMETRICS, 1983, 39 (03) : 802 - 802
  • [38] Genotoxicity evaluation of medical devices: A regulatory perspective
    Kumaravel, Tirukalikundram S.
    Sathya, Tiruvathipuram N.
    Balaje, Ramalingam
    Pradeepa, Pitchaipillai
    Yogaraj, Desikan
    Murali, Malliga R.
    Navaneethakrishnan, K. R.
    Murugan, Sivasubramanian
    Jha, Awadhesh N.
    MUTATION RESEARCH-REVIEWS IN MUTATION RESEARCH, 2022, 789
  • [39] Risk management activities of regulatory authorities of veterinary medicinal drugs for the containment of antimicrobial resistance - the German perspective
    Klee, S.
    JOURNAL OF VETERINARY PHARMACOLOGY AND THERAPEUTICS, 2009, 32 : 59 - 60
  • [40] Regulatory Aspects of Pharmacokinetic Profiling in Special PopulationsA European Perspective
    Monica Edholm
    Eva Gil Berglund
    Tomas Salmonson
    Clinical Pharmacokinetics, 2008, 47 : 693 - 701