This article is a summarized translation of the most recent regulation published by China’s National Medical Products Administration (NMPA) on postapproval changes (PACs). The author provides an overview of the regulation and its annexes for PACs and discusses their impact on manufacturing site change management, change classification determination and consultation, and reporting categories.   Introduction On 13 January 2020, the NMPA published an announcement on t...

This article provides an overview of the Chinese regulations and guidance documents for cell and gene therapy products (CGTPs).   Introduction As early as 1993, Chinese regulators provided guidance on clinical research for somatic cell and gene therapy. More regulations, laws, and guidances have since been published, either specific to, or including, CGTPs. The two most recent publications have been draft guidelines for clinical studies for immune cell therapy produc...

This article discusses a new process for the approval of drugs in China called “bundling review.” The author describes the bundling review process, implemented by Chinese regulators in 2015, aimed at simplifying and accelerating the review of new drugs with previously approved active pharmaceutical ingredients, excipients and primary packaging materials. The author provides information contained in several annual regulatory updates to the 2015 guidance and highlights some ...

This article summarizes key points of the “Measures” for the Administration of Human Genetic Resources,” published by the Peoples’ Republic of China’s State Council and currently available only in Chinese. The author reviews the first three of six chapters in the new document and the revised and updated “Measures” as applied to defining “human genetic resources” and regulations imposed by China’s Human Genetic Resource Administration for human genetic resource collection a...

The Chinese regulatory system for marketing authorization differs from other regulatory systems, especially with regard to inspection and analytical testing requirements. This article is a translation of the first official notification, providing details on the differences, as well as expected timelines.   Introduction   As part of the Marketing Authorization (MA) procedure for pharmaceutical products in China, the Chinese National Medical Products Administration (...

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...

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...

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...

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...

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 ...

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...

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...