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

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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).

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Companies Mentioned
1. AstraZeneca PLC (AZN)
2. FibroGen (China) Medical Technology Development Co., Ltd.

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.

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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.

Key Highlights:

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.

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