On December 26, 2018, the Chinese agency for regulating drugs and medical devices (the National Medical Products Administration; “NMPA”) released the Announcement on Issuing the Administrative Measures for Overseas Inspections of Drugs and Medical Device (hereinafter referred to as “Regulation”) to ensure the quality and safety of drugs and medical devices developed or manufactured abroad. For the first time, a set of detailed working procedures has been laid out to equip NMPA with standardized guidance for overseas inspections. It is a decisive step of the Chinese government to build up effective post-market supervision and administration.
The primary goal of overseas inspections is to ensure that the development and manufacturing of drugs and medical devices meet the same standards applicable to domestic products in China, as mandated by law. If a product falls short of the requirements, its entry to China may be halted. It can be inferred from the release of this new Regulation, and the directives from the central government to intensify overseas inspections that foreign manufacturing sites and R&D centers will have to gear up for more frequent inspections from NMPA.
In this article, the Regulation’s background and content will be analyzed in detail, and practical recommendations to overseas MAHs1 , manufacturing sites and R&D centers will be presented.
1.1International Practice and Practice in Chin
Overseas inspection is not a recent news for foreign pharmaceutical companies, considering that NMPA has started overseas inspections of drug companies early in the year 2011, and medical device companies in 2015. To date, NMPA has delegated 116 inspection teams to inspect 131 drug products produced in 25 countries.
Overseas inspection is a global practice for drugs and medical devices inspection. U.S. has been conducting overseas inspections for more than fifty years. The Guide to International Inspections and Travel provides FDA inspectors with standard procedures of overseas inspections. A company that fails the inspection will be issued a warning letter rejecting the shipment of its products to the US. According to statistics, China received the largest number of warning letters issued by FDA to a single country in the year 2017 and 2018. As for Australia, in addition to legislations on overseas inspections, Therapeutic Good Administration has assigned a range of international agreements with other countries to facilitate overseas inspections.
“China conducted much fewer overseas inspections compared to developed countries. In order to keep pace with all international practice, when drafting the regulation, NMPA has gained experience in a global scale.” as stated by one of its officials. Meanwhile, NMPA has been recruiting more inspectors which makes more overseas inspections feasible. In the executive meeting on April 12, 2018, the State Council explicitly required bolstering overseas inspections of drugs and medical devices. NMPA emphasized the same in July, 2019.
1.2Practice Calls for Clearer Guidance on Overseas Inspections
China is the world's second largest healthcare market after the U.S. In the year 2017 alone, drugs and medical devices with an estimated value of 37 billion 700 million USD from 60 countries and regions have been imported to China. With the swelling number of imported drugs and medical devices, there is an increasing need to guarantee the quality of imported products. Before the Regulation, overseas inspections have been conducted mainly based on general substantive laws, such as Regulations on Supervision and Administration of Medical Devices and the Good Manufacturing Practice for Drugs. However, there were no detailed rules and procedural guidance. Early in 2012, former State Food and Drug Administration formulated Administrative Measures for the Inspection of Overseas Pharmaceutical Manufacturers (Draft for Comments), which has never come into force. It has been demonstrated by the inspectors that in practice the lack of specific laws to support it makes it difficult to eliminate obstacles in law enforcement.2 Another, without clear guidelines, companies were left with uncertainty.