Literature DB >> 30235555

Characterizing Good Review Practices: A Survey Report Among Agencies of APEC Member Economies.

Li-Ling Liu1, Neil McAuslane2, Meir-Chyun Tzou3, Herng-Der Chern4, Lawrence Liberti2, Mike Ward5, Jaw-Jou Kang6.   

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.

Keywords:  APEC; CIRS; Taiwan FDA; good review practices; regulatory review

Year:  2013        PMID: 30235555     DOI: 10.1177/2168479013494394

Source DB:  PubMed          Journal:  Ther Innov Regul Sci        ISSN: 2168-4790            Impact factor:   1.778


  1 in total

1.  The Jordan Food and Drug Administration: Comparison of its Registration Process with Australia, Canada, Saudi Arabia and Singapore.

Authors:  Wesal Salem Al Haqaish; Hayel Obeidat; Prisha Patel; Stuart Walker
Journal:  Pharmaceut Med       Date:  2016-12-15
  1 in total

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