The State Drug Administration of China (SDA, formerly (before name change in 2018), CFDA) has issued the 2017 Drug Inspection Report recently (June 8) which summarizes, conducts statistics of, and analyzes the work of CFDA’s pre-approval inspection, pharmaceutical GMP follow-up inspection, unannounced inspection for pharmaceuticals, overseas inspections for imported pharmaceuticals, GSP unannounced inspection, GMP observation inspection by foreign organizations, etc. in 2017, and contains many highlights. Let’s check them.
Highlight I: Increased inspection density, surging number of pharmaceutical GMP follow-up inspections
Table 1 shows the completion situation of the pharmaceutical inspection tasks by CFDA in 2017 and 2016. Compared to 2016, the total number of inspections in 2017 increased greatly, wherein, the item mainly increased was pharmaceutical GMP follow-up inspection, with the increase of over 200 inspections, followed by overseas inspections for imported pharmaceuticals, with the increase of over 7 times.
|
Inspection |
Amount of Inspected Enterprises / Varieties in 2017 |
Amount of Inspected Enterprises / Varieties in 2016 |
|
Pre-approval inspection |
52 |
34 |
|
Generic drug consistency on-site inspection |
12 |
16 |
|
Pharmaceutical GMP follow-up inspection |
428 |
204 |
|
Unannounced inspection for pharmaceuticals |
57 |
39 |
|
Overseas inspections for imported pharmaceuticals |
51 |
7 |
|
GSP unannounced inspection |
67 |
50 |
|
GMP observation inspection by foreign organizations. |
84 |
81 |
|
Total |
751 |
593 |
Table 1 List of Pharmaceutical Inspection Tasks Completed in 2017 and 2016
Highlight II: Inspections of biological drugs and chemical drugs accounting for the majority of the pre-approval inspections
CFDA conducted pre-approval inspections mainly according to the Provisions for Drug Registration, Requirements for On-site Verification for Drug Registration, and Announcement on Matters Related to the Consistency Evaluation of the Quality and Efficacy of Generic Drugs, etc.










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