As the global leader in and wind vane for drug regulation, the U.S. FDA’s management measures for the pharmaceutical industry and regulation trend have been the focus of pharmaceutical practitioners. FDA issued 17 warning letters on production quality (including 6 in January, 7 in February, and 4 in March) in 2018 Q1, with the specific information as shown in the following table:

Table 1 Basic Information of FDA’s Warning Letters in 2018 Q1

Fig. 1 Distribution of Warning Letters of FDA in 2018 Q1 by Country

According to our brief analysis of the warning letters in Q1, from the perspective of country, China topped, accounting for 41%, followed by India and South Korea. FDA is committed to safeguarding the health and safety of consumers, and has been focusing on India and China all the time. Especially since the formal implementation of the U.S.-EU Mutual Recognition Agreement (MRA) on November 1, 2017, the examination resources of the EU and the U.S. will be rearranged, and India and China will become the focus where the examination resources will lean to because they are big countries in pharmaceuticals and have frequent problems in recent years, which shall be focused on. Such layout of examination resources may lean to the entire Asia, from the perspective of distribution of countries receiving warning letters. Furthermore, FDA’s regulation of Asian pharmaceutical product manufacturers is expected to maintain restrict as influenced by Trump’s trade protectionism.

On the other hand, there were more letters on preparations (11) while less on APIs, however, this does not mean that FDA will reduce the frequency of inspecting API enterprises, as inspection behaviors represented by warning letters in 2018 Q1 were often implemented in 2017 Q3 and Q4. Therefore, the warning letters on preparation enterprises being more than that on API enterprises in Q1 showed FDA’s inspection and strict control of preparation enterprises all the time, and its relatively low frequency of inspecting API enterprises in 2017 Q3 and Q4.

Main problems inspected: Summary of Warning Letters Issued by FDA in 2018 Q1

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