Page 50 - 2018食藥署年報(英文版)

To collect feedback from local applicants and health bureaus and optimize application
platform and user’s interface, TFDA establishes a back-stage management and statistical analysis
area in 2018 to strengthen the management of drug supply chain, comply with local health
bureau’s inspections and ensure safe drug use.

Section 4 Good Distribution Practice (GDP)

Origin of Policy

The goal of implementing GDP is to extend the requirements on medicinal products quality
control from GMP (in terms of manufacturing) to GDP (in terms of distribution), to ensure the

quality and the integrity of medicinal products during storage and transportation, to effectively
respond to emerging drug recall incidents, to properly distribute to the consumer within a
reasonable time frame and to prevent falsified medicinal products from entering the supply chain.
The ultimate goal is to ensure drug quality and safety of the public.
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) officially released GDP
in June 2014, which has then become a well-recognized GDP in the world. GDP is now well
practiced in many international organizations and countries, including WHO, EU, Singapore,

Malaysia, UK, Germany, Switzerland, USA, and Australia. To implement quality management of
drug distribution, ensure drug safety, upgrade international competitiveness, the TFDA promotes
global well-recognized GDP policy accordingly.

Implementation Measures

1. GDP-associated measures

Starting from 2011, the TFDA has initiated GDP policy by providing consultation and
educational training sessions (e.g. focused forum, technology seminar, observation tour in

pharmaceutical companies, etc.), organizing 710 sessions of on-site GDP experts/consultants
counseling, and awarding 107 manufacturers with excellent performance. The TFDA also actively
participates in communications and promotion activities, organizes several orientation meetings,
convenes negotiation meetings and public hearing and reaches consensus on management policies
and schedules with the industry. In addition, the TFDA not only convenes an advisory board
meeting composed of industrial/official/academic experts to discuss about management system
and technology regulations and summarize a frequent Q&A for the applicant’s reference, but also
establishes a PIC/S GDP zone (including approval lists, counseling programs, Q&A and educational

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