II. Main findings

　　(I) The situation of violations of CFDA Announcement No.94

Table 6-2 The situation of violations of CFDA Announcement No.94 by enterprises identified in unannounced inspection in drug circulation enterprises

　　Main findings:

1. Fail to store and transport the drugs and monitor the temperature and humidity in accordance with the regulations.

2. For purchase and sales of drugs, the certificate (license certificate), bills (invoice, the sheet along with the goods), account (materials account, financial account), goods (drugs) and money (payment for drugs) cannot be corresponding to or consistent with each other; fail to warehouse the drugs with concealed accounts established, fail to manage the drugs after including them into quality management system, use personal account to conduct business dealings, and other situations.

3. The enterprises falsified the source for drug procurement, fabricated sales flow of drugs, tampered the data of computer system and temperature and humidity monitoring system, and concealed the real drug purchase-sales-storage records, bills, voucher and data, the drug purchase-sales-storage records were incomplete and untruthful and distribution behaviors were untraceable.

(II) The situation of violation of Good Supply Practice for Pharmaceuticals (GSP) of CFDA by enterprises

　　The GSP deficiencies of drug circulation enterprises mainly focused on the General Provisions, Storage and Maintenance, Sales. The main problems were:

1. Fail to conduct business in accordance with the law and have false and cheating behaviors.

The enterprise changed the registered business address without authorization; established warehouses to store drugs beyond the scope of business license; provided conditions for illegal distribution of drugs; falsified the procurement source and sales flow of drugs; concealed bills and provided false materials; provided untruthful self-inspection report; falsified tax return; and tampered temperature and humidity monitoring data.

2. Fail to store the drugs in accordance with regulations and fail to conduct effective monitoring and control of the temperature and humidity of warehouse.

3. The bills, account, goods and payment was inconsistency for the purchase and sales of drugs, and the enterprise failed to implement national regulations for the sales of special medicines.

Part VII GMP Observation Inspection by Foreign Organizations

　　I. Overview of Inspections

　　Based on the requirements in the letter from the Department of International Cooperation of China Food and Drug Administration, CFDI organized to complete 81 observation inspections on pharmaceutical manufacturers in 2016, involving 76 manufacturers, covering 20 provinces (municipalities) including Zhejiang and Shandong etc., of which Zhejiang, Shandong, Jiangsu, Guangdong, Hubei, Hainan and Hebei accounted for 80%, which was basically consistent with last year, but the proportion of each province showed a slight change.

In 2016, the inspection organizations involved in the observation inspection included 12 international organizations or foreign drug regulatory authorities, such as World Health Organization (WHO), European Directorate for Quality Medicines (EDQM), United States Food and Drug Administration (US FDA), Germany BGV, Agência Nacional de Vigil?ncia Sanitária (ANVISA) and French National Agency for Medicines and Health Products Safety (ANSM). Nine pharmaceutical manufacturers were identified with critical deficiencies and failed the on-site inspections by foreign regulatory authorities / inspection organizations (accounting for 11%).

Compare with that in 2015, the fail rate was slightly increased. Among 9 enterprises failing in the inspection, most critical deficiencies involved the problems in data integrity (including conducting repeated tests until qualified, conducting tests after changing system time, deleting data, deleting the audit and tracking records, selectively using data, modifying the name of the electronic data, test sample injection, failing to record timely, untruthful records, loss of data and records, insufficient file record control, etc.), and some enterprises involved such aspects as unreasonably developed material standards and inadequate measures to avoid cross contamination. Overall, the problems in the data integrity is relatively prominent and were also the main reasons for the increase of fails of domestic enterprises in foreign inspections in 2016, which also reflects the change tendency of the current drug inspection.

The observation inspections this year involved a total of 172 drugs, including 119 APIs, 23 oral solid preparations, 19 injections，5 biological products and 6 other products. Of the 81 inspections, there were 62 inspections involving APIs, accounting for 69%, and there were 12 inspections involving oral solid preparations, accounting for 13%. Of the drugs involved, APIs had the largest proportion, followed by oral solid preparations, and there was relatively less export of other dosage forms. Compared with that in 2015, the proportion of other dosage forms (including sterile products and biological products) receiving inspection increased, from 10% in 2015 to 18% in 2016.