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Characterizing Good Review Practices: A Survey Report Among Agencies of APEC Member Economies.
Liu, Li-Ling; McAuslane, Neil; Tzou, Meir-Chyun; Chern, Herng-Der; Liberti, Lawrence; Ward, Mike; Kang, Jaw-Jou.
Afiliação
  • Liu LL; 1 Division of Medical Devices and Cosmetics, Food and Drug Administration, Taipei, Taiwan.
  • McAuslane N; 2 Centre for Innovation in Regulatory Science, London, UK.
  • Tzou MC; 3 Division of Drugs and New Biotechnology Products, Food and Drug Administration, Taipei, Taiwan.
  • Chern HD; 4 Center for Drug Evaluation, Taipei, Taiwan.
  • Liberti L; 2 Centre for Innovation in Regulatory Science, London, UK.
  • Ward M; 5 International Programs Division, Therapeutic Products Directorate, Health Canada, Ottawa, ON, Canada.
  • Kang JJ; 6 Food and Drug Administration, Taipei, Taiwan.
Ther Innov Regul Sci ; 47(6): 678-683, 2013 Nov.
Article em En | MEDLINE | ID: mdl-30235555
ABSTRACT
As a first step in the implementation of the Asia-Pacific Economic Cooperation (APEC) Best Regulatory Practice Project, the Centre for Innovation in Regulatory Science conducted a gap analysis survey among regulatory agencies of 14 APEC member economies to assess the current use of good review practices (GRevP) to support transparent, consistent, predictable, and good-quality regulatory decision making. Although the majority of responding agencies have established some form of GRevP, most practices are currently evolving and are applied on an informal basis. Most agencies have developed standard operating procedures and guidelines and use a variety of training methods. The use of a common approach to regulatory review across jurisdictions would help build trust and confidence in each agency's processes, setting the stage for the possibility of work sharing across resource-constrained agencies and bringing consistency and transparency to the review process.
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Texto completo: 1 Base de dados: MEDLINE Tipo de estudo: Guideline / Health_economic_evaluation / Qualitative_research Idioma: En Ano de publicação: 2013 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Tipo de estudo: Guideline / Health_economic_evaluation / Qualitative_research Idioma: En Ano de publicação: 2013 Tipo de documento: Article