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Latest Chinese Guidebook for Regulations on the Administration of Overseas Inspection for Imported Drugs and Medical Devices (2019 Edition)

Report Summary:
China is one of the fastest growing global economies with one fifth population in the world. Nowadays, China has become the world's second largest healthcare market after the United States. Along with sustained economic and population growth, and rapid population aging, the Chinese healthcare market has maintained annual compound growth rate above 16 % since 2010s. The statistical data showed that scale of the Chinese healthcare market has reached RMB 6464.1 billion by 2017(about equivalent to US$973.5 billion). Among them, the total value of drug sales was RMB 2001.6 billion (US$301.1 billion) based on the statistical data of three sales terminals for public hospitals, retail pharmacies and grassroots medical institutions with annual compound growth rate of 14.37%; the total value of medical device sales was RMB 663.2 billion (US$95.2 billion) with annual compound growth rate of 20.27%. Facing a gigantic population and rapid population aging, the Chinese government, on one side, accelerated the priority approval of innovative drugs and medical devices and relaxed the market access for overseas drugs and medical devices, on other side, intensified the supervision and administration for drugs and medical devices at the post—marketed and expecting into the market. In recent years, China’s fast-track approval time is much shorter than any other country, which attracts more and more overseas pharmaceutical and medical device manufacturers to enter the Chinese healthcare market. Undoubtedly the Chinese healthcare market of nearly 1.4 billion populations is a huge business opportunities for the overseas pharmaceutical and medical device manufacturers. At the same time, the Chinese regulatory authorities are changing regulatory framework to intensify the supervision and administration.

The Chinese National Medical Products Administration ("NMPA") has enacted the latest “Regulations on the Administration of Overseas Inspection for Imported Drugs and Medical Devices” on December 26, 2018, which has been come into immediately effective from the date of issuance. The supervision and administration for China’s healthcare market is not only the domestic full-coverage, but also start to get involved overseas manufacturers exporting drugs and medical devices to China. The latest “Regulations” clearly state that, overseas inspections targeting drugs and medical devices that have been or will be launched on the Chinese market, are not limited to on-site inspections carried out in the production location, but are expanded to cover inspections conducted at places of the overseas research and development, even on production sites of suppliers or other contracting agencies of the raw materials, auxiliary materials, and packaging materials. In deciding whether to carry out an overseas inspection, the Chinese regulatory authority will give consideration to multiple risk factors related to a drug or a medical device that arise in different processes, including the evaluation and approval of its registration, supervisory checks, tests, complaints and reports, and the monitoring of adverse reactions or events. Moreover, the “Regulations” require that the comprehensive assessment for inspection results should be made under the principle of risk assessment, adding that inspection conclusions should be drawn by comprehensively taking account of the nature and gravity of product defects and the category of the product under evaluation, and are classified into three types which are "up-to-standard", "up-to-standard after the completion of rectification work" and "substandard". Furthermore, the “Regulations” state that, inspection results will be responded differently through risk control measures and through case establishment and investigations. In the event that grave quality risks are found in such inspections, immediate measures must be taken to bring the risks under control. This is challenge to overseas pharmaceutical and medical device manufacturers. To capture the huge business opportunities of the Chinese healthcare market and seize a larger part of Chinese healthcare market, how do the foreign pharmaceutical and medical device manufacturers in compliance with the latest Chinese regulations on pharmaceutical and medical devices? How do the overseas pharmaceutical and medical device manufacturers operate business smoothly in China? Most importantly, the overseas and multinational pharmaceuticals and medical device manufacturers should always stand ready to respond to further regulation and policy changes occurred in China.

The overseas and multinational pharmaceutical and medical device manufacturers and their senior executive officers engaging in regulatory affairs need a thorough knowledge of the Chinese “Regulations on the Administration of Overseas Inspection for Imported Drugs and Medical Devices”. China’s regulatory approach and culture are unique.

Latest Chinese Guidebook for Regulations on the Administration of Overseas Inspection for Imported Drugs and Medical Devices (2019 Edition) is an essential resource for overseas and multinational pharmaceutical and medical device manufacturers to respond the Chinese regulatory authorities’ overseas inspection for imported drugs and medical devices, which provided a detailed guidance of comprehensive and thorough knowledge of the Chinese regulations on the administration of overseas inspection for imported drugs and medical devices, and to smoothly navigate complex regulatory requirements step by step.
This guidebook is organized as follows. Chapter 2 provides a brief description for the China’s healthcare market landscape and rapidly changing regulatory framework as background for audience. Chapter 3 introduces the general regulations for overseas inspection for imported drugs and medical devices, which cover the applicable objects and scopes, who will be responsible for the overseas inspection of drugs and medical devices, who will be responsible for the specific organization and implementation of overseas inspection of drugs and medical devices, and how will announce the basic situation of the overseas inspection and the processing results. Chapter 4 elaborates how to determine the overseas inspection task for drugs and medical devices. Chapter 5 expounds the initiating procedures for overseas inspection. Chapter 6 elaborates the overseas on-site inspections for drugs and medical devices. Chapter 7 expounds the audit and disposal for results of overseas on-site inspections. Chapter 8 introduces the Chinese regulatory authority’s requirements for the overseas marketing authorization holder to authorize an agency within the territory of China to undertake the overseas inspection affairs. Chapter 9 introduces the lists and contents of site master files. Chapter 10 describes and sketches a panoramic view of the overseas inspection for drugs and medical devices. Chapter 11 provides a full set of the English and Chinese bilingual annexes, which cover the notification of overseas inspection, the basic situation form of overseas inspection product, the pre-notification for overseas inspection, and the notification for overseas inspection results.

The audiences of this guidebook are the overseas pharmaceutical and medical device companies wishing to enter into the Chinese healthcare market, and the multinational pharmaceutical and medical device companies have penetrated into the Chinese healthcare market, and their senior executive officers engaging in regulatory affairs expecting to understand the latest Chinese regulations on the administration of overseas inspection for imported drugs and medical devices. After having skimmed through this guidebook, audiences can clearly acquire a comprehensive and thorough knowledge of the latest Chinese regulations on administration of overseas inspection for imported drugs and medical devices. Access China Management Consulting Ltd hopes this guidebook, based on the full and accurate regulations, can guide overseas and multinational pharmaceutical and medical device manufacturers to achieve a successful entry into the Chinese healthcare market, and smoothly operate their companies in China.


Major Market Players:
AstraZeneca PLC (AZN)
FibroGen (China) Medical Technology Development Co., Ltd.
Reasons To Buy
The Chinese National Medical Products Administration ("NMPA") has enacted the latest “Regulations on the Administration of Overseas Inspection for Imported Drugs and Medical Devices” on December 26, 2018, which has been come into immediately effective from the date of issuance. The supervision and administration for China’s healthcare market is not only the domestic full-coverage, but also to get involved overseas manufacturers exporting drugs and medical devices to China. The latest “Regulations” straightway involved with the overseas pharmaceutical and medical device manufacturers exporting drugs and medical devices to China. The latest “Regulations” clearly state that, overseas inspections targeting drugs and medical devices that have been or will be launched on the Chinese market, are not limited to on-site inspections carried out in the production location, but are expanded to cover inspections conducted at places of the overseas research and development, even on production sites of suppliers or other contracting agencies of the raw materials, auxiliary materials, and packaging materials. In deciding whether to carry out an overseas inspection, the Chinese regulatory authority will give consideration to multiple risk factors related to a drug or a medical device that arise in different processes, including the evaluation and approval of its registration, supervisory checks, tests, complaints and reports, and the monitoring of adverse reactions or events. Moreover, the “Regulations” require that the comprehensive assessment for inspection results should be made under the principle of risk assessment, adding that inspection conclusions should be drawn by comprehensively taking account of the nature and gravity of product defects and the category of the product under evaluation, and are classified into three types which are "up-to-standard", "up-to-standard after the completion of rectification work" and "substandard". Furthermore, the “Regulations” state that, inspection results will be responded differently through risk control measures and through case establishment and investigations. In the event that grave quality risks are found in such inspections, immediate measures must be taken to bring the risks under control. This is challenge to overseas pharmaceutical and medical device manufacturers. To capture the huge business opportunities of the Chinese healthcare market and seize a larger part of Chinese healthcare market, how do the foreign pharmaceutical and medical device manufacturers in compliance with the latest Chinese regulations on pharmaceutical and medical devices? How do the overseas pharmaceutical and medical device manufacturers operate business smoothly in China? The overseas and multinational pharmaceutical and medical device manufacturers and their senior executive officers engaging in regulatory affairs need a thorough knowledge of the Chinese “Regulations on the Administration of Overseas Inspection for Imported Drugs and Medical Devices”. China’s regulatory approach and culture are unique.
—A brief description for the China’s healthcare market landscape and rapidly changing regulatory framework that let the overseas and multinational drug and medical device manufacturers clearly understand the present-day realities of the Chinese healthcare market landscape and rapidly changing regulatory framework, and tell the overseas and multinational drug and medical device manufacturers the opportunities and challenges.
—The general regulations for overseas inspection for imported drugs and medical devices, which clarify the applicable objects and scopes of overseas inspection, who will be responsible for the overseas inspection of drugs and medical devices, who will be responsible for the specific organization and implementation of overseas inspection of drugs and medical devices, and how will announce the basic situation of the overseas inspection and the processing results.
—How the Chinese regulatory authority determines the overseas on-site inspection task for drugs and medical devices.
—How the Chinese regulatory authority initiates procedures for overseas on-site inspection for imported drugs and medical devices, which is important for the overseas and multinational manufacturers of imported drugs and medical devices and the agents within the territory of China designated by the overseas marketing authorization holders, because they must be in compliance with these procedures.
—How the Chinese regulatory authority implements the overseas on-site inspections for imported drugs and medical devices to smoothly navigate complex regulatory requirements step by step, which is important for the overseas and multinational manufacturers exporting drugs and medical devices to China, because they must be in compliance with these complex regulatory requirements.
—How the Chinese regulatory authority conducts the audit and disposal for results of overseas on-site inspections, which is a key step that decide whether the drugs and medical devices imported into China can be firmly stood on the Chinese healthcare market.
—The Chinese regulatory authority’s requirements for the overseas marketing authorization holder to authorize an agency within the territory of China to undertake the overseas inspection affairs are the Chinese distinct regulatory approach. The overseas marketing authorization holders must abide by this distinct Chinese regulatory approach.
—The detailed Chinese regulatory authority‘s the specific requirements of lists and contents of Site Master Files for overseas on-site inspection of imported drugs and medical devices guide the overseas marketing authorization holders how smoothly navigate complex regulatory requirements step by step.
—A panoramic view of the Chinese overseas inspection for imported drugs and medical devices that let the overseas MA holders and overseas drug and medical device manufacturers wishing to enter into the Chinese healthcare market clearly understand the Chinese regulatory authorities’ distinctive regulatory current status.
—A full set of the English and Chinese bilingual notifications and form relating to the overseas on-site inspection for imported drugs and medical devices facilitate the overseas MA holders and overseas drug and medical device manufacturers wishing to enter into the Chinese healthcare market to respond to Chinese regulatory authority‘s overseas on-site inspection.

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Table of Contents

Contents.1

Chapter 1 Executive Summary.3

Chapter 2 China’s Healthcare Market Landscape and Rapidly Changing Regulatory Framework: Opportunities and Challenges for Overseas and Multinational Pharmaceutical and Medical Device Manufacturers.7
2.1. China’s Healthcare Market Landscape.7
2.2. What is cause to drive the regulatory framework rapid Change?. 8

Chapter 3 General Regulations for Overseas Inspection for Imported Drugs and Medical Devices.13

Chapter 4 Determination of Overseas Inspection Task.15

Chapter 5 Initiating Procedures of Overseas Inspection.16

Chapter 6 Overseas On-site Inspection.19

Chapter 7 Audit and Disposal.21

Chapter 8 The Relevant Requirements of the Overseas MA Holder to Authorize the Agency for Overseas Inspection Affairs.26

Chapter 9 Lists and Contents of Site Master Files.28
9.1. Lists and Contents of Site Master Files for Drugs.28
9.2. Lists and Contents of Site Master Files for Medical Devices.35

Chapter 10 A Panoramic View of the Overseas Inspection for Drugs and Medical Devices.40
Figure 10. A Panoramic View of the Overseas Inspection for Drugs and Medical Devices.41

Chapter 11 Appendices.46
Annex 1: Notification of Overseas Inspection.46
Annex 2.1: Basic Situation Form of Overseas Inspection Product for Drug.49
Annex 2.2. Basic Situation Form of Overseas Inspection Product for Medical Device.53
Annex 3. Pre-Notification for Overseas Inspection.56
Annex 4. Notification for Overseas Inspection Results.58

Research Process

The research starts with the extensive procurement process of data/information and statistics from company annual reports, government websites, statistic agencies, and paid databases. This information creates a base for the study. This information also helps to define the scope and to narrow down the area for study for the market. This raw information is processed and analysed to extract crisp data points which currently affect or are likely to affect the industry over the forecast period. After analysing the information, a proprietary market estimation & forecast technique is applied, which generates the quantitative figures/sizes of the market/sub-segments in the current scenario as well as for over the forecast period. After populating the market sizes & estimates, numbers are verified with the industry participants and key opinion leaders. The wide network of industry participants performs a value addition in the research and verify the numbers & estimates of the study. In the last stage of the research process, a final report is prepared which is then published on different websites as well as distributed through various channels. Below figure contains the different stages of the whole research performed to produce the report.

After populating the market sizes & estimates, numbers are verified with the industry participants and key opinion leaders. The wide network of industry participants performs a value addition in the research and verify the numbers & estimates of the study. In the last stage of the research process, a final report is prepared which is then published on different websites as well as distributed through various channels. Below figure contains the different stages of the whole research performed to produce the report.

DATA MINING

Data mining is one of the extensive stages of our research process. It involves the procurement of market data and related information through different verified & credible sources. This step helps to obtain the raw information about the supply chain of the industry, the monetary process of different Products & End-Uses, the pool of market participants & the nature of the industry and the scope of the study. The data mining stage comprises both primary as well as secondary sources of information. Some of the key data sources are as follows:

Secondary Research In the process of secondary research, various sources are referred to identify and collect industry trends and information for the research process. We at having access to some of the most diversified and extensive paid databases which give us the most accurate data/information on markets sizes, Products and pricing.

In the primary research process for data mining, various key industry participants from both supply and demand side are interviewed to obtain both qualitative as well as quantitative information on the market. In-depth interviews with key primary respondents, including industry professionals, subject matter experts (SMEs), industry consultants, and C-level executives of major companies are conducted to obtain critical qualitative and quantitative aspects pertaining to the market, as well as to assess the prospects for market growth over the forecast period.

ANALYSIS

This step involves the analysis & mapping of all the information procured from the previous step. This step also encompasses the scrutiny of data discrepancies observed across various data sources and finalising the appropriate data for estimation and forecasting. This analysis is done by our experienced panel of industry analysts.

MARKET ESTIMATION

Understanding and penetrating the market in terms of valuation is a crucial task in the process of business research. This again becomes significantly important while investing and choosing the business opportunities. In this regard, we perform two ways market sizing approach simultaneously namely top-down and bottom-up approaches. In this step, we place different data points, numeric attributes, information, and industry trends at an appropriate space in order to deduce the estimates & forecast values over the coming years. We use different mathematical models to estimate the market sizes of different economies and segments. Each of which is further summed up to define the total market. We own a proprietary tool for market estimations which helps us to comprehend market size estimates & forecasts for different markets and industries. Below figure explains the process of market estimation using independent tool employed by our analysts to get the sizing off the market.

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