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    Communication With the Chinese Center of Drug Evaluation (CDE) During Drug Development

    This article provides an English translation of the Chinese Center for Drug Evaluation’s (CDE’s) regulations for communication with CDE on meeting management practices. The author describes standard procedures for requesting, preparing for, scheduling, conducting, rescheduling/cancelling and documenting meetings or other correspondence with the agency.   Introduction   In October 2018, China’s national drug regulatory body, the National Medical Products Administrat...
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    Chinese Health Policy and Regulatory Authorities Overview

    This article covers recent changes to China’s healthcare regulatory authorities and healthcare policy administration. The author explains the responsibilities and functions of the many government departments, agencies and regulatory bodies responsible for overseeing drugs, food, medical devices, testing and evaluation since the reorganization and restructuring of the former Chinese Food and Drug Administration (CFDA) and several other organizations in March 2018.   Intr...
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    China’s New, Faster Marketing Authorization Approval Program

    This article discusses Chinese pharmaceutical regulatory issues from two perspectives: the regulatory organizational structure of the responsible government bodies and the regulatory legislative system. The author reviews changes initiated by the Chinese government aimed at manufacturing and marketing significantly more drugs and encouraging faster delivery of novel drug accessibility to patients in China. Topics include clinical trial review and approval, marketing author...
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    New Regulations Imposed on Overseas Inspections of Drugs and Medical Devices

    This article discusses the most recent regulations imposed by China’s National Medical Products Administration (NMPA) on foreign manufacturers regarding China’s inspections of drugs and medical devices. The author covers inspection details from four chapters in the new regulation, all pertaining to general provisions, inspection planning, conducting an inspection, the inspection report and inspection outcomes. The author discusses an Annex to the regulation covering inspec...
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    CFDI's Global Drug Inspection Trend Study Offers Regulatory Updates and Opinions

    To help keep regulatory professionals up-to-date on current thinking by global regulatory agencies, the Chinese Center of Food and Drug Inspection (CFDI) released a new electronic journal covering hot topics and developments in international drug manufacturing inspections. This article summarizes the key points including regulatory thinking and opinions from global regulatory authorities and organizations; timely updates on regulations, guidance, regulatory measures and ...
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    CFDA Publishes Four Draft Guidances on Inspections of Generic Drug Development

    This article provides the details of four draft guidances published on 21 December 2016 by the China Food and Drug Administration (CFDA) regarding on-site inspection of generic drugs, including how CFDA will be evaluating their quality and efficacy and possible inspection outcomes and the responsibilities of 31 local province level FDA inspection teams in China. 1 The first guidance published by the CFDA covers on-site inspections of generic drug development establi...
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    Draft CFDA Guidance on Drug Data Management Practices

    The China Food and Drug Administration (CFDA) has recently issued a new draft guidance document on data integrity, covering the entire data lifecycle from R&D to commercial production and distribution. This article is a translation of the summary of the draft guidance. On 10 October 2016, CFDA issued draft guidance of drug data management practices for public comment. 1 Its purpose as detailed in Chapter I is the regulating the management of relevant data during th...
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    Registration Procedures for Medicinal Products in China

    This article provides a high-level introduction to the Chinese regulatory framework, including requirements for marketing approval of imported drugs. An increasing number of pharmaceutical companies based outside China are interested in marketing their products in China as evidenced by the increasing number of clinical trial and marketing applications submitted by foreign companies. Obtaining marketing authorization approval equal to an Import Drug License (IDL) approv...