I. Overview of Inspections

　　(I) Overview of annual inspection tasks

The total number of CFDA Overseas Inspection was 49 inspections.

　(1) The inspection tasks in 2016 involved 19 countries. There were relatively more varieties in Europe and North America, the varieties of such countries with high regional quality risks as India and Vietnam account for certain proportion, and at the same time, the inspection on the varieties in South America and Australia was also intensified.

(2) The inspection followed the principle that inspection shall serve the evaluation and approval and took into consideration the safety requirements for the marketed products. The proportion of the varieties under review was increased, and the product under application for clinical trials, application for production and re-registration and in the stage of supplementary application shall all be included in the scope of inspection. The reason for the inspection on the marketed products was mainly port quality inspection problems. The iodoprestamine injection, a variety with high risks in adverse reaction monitoring manufactured by a foreign company, was added for inspection.

　　(3) The inspection tasks were characterized as comprehensive varieties and broad dosage forms, and the extended inspection on chemical preparations was intensified. 40 chemicals were involved, including injections, solid preparations, implant and nasal sprays, of which there were 3 biochemical products, 6 APIs for extended inspection; 11 vaccines, blood products and therapeutic biological products; and 4 botanical drugs.

　　(II) The implementation of the inspections in 2016

Due to the inspection tour of CFDA and CFDI in the first half year, the change in relevant foreign affairs and production arrangement of enterprises, CFDI submit the inspection tasks of 37 varieties throughout the year: the inspection tasks of 15 varieties have been completed, of which on-site inspection was conducted on 7 varieties, and three of them failed, accounting for 42%; the enterprises of 8 varieties proactively withdrew the import registration certificate or had their application returned during the organization of the inspections, account for 17% of total annual plan. For another 21 varieties, due to production scheduling of enterprises, the inspection is scheduled to be completed in the first quarter of 2017, and relevant formalities of foreign affairs are being dealt with. For the other 12 varieties, because the enterprises cannot accept inspection in the first quarter of 2017, CFDI has reported to the Department of Drug and Cosmetics Supervision to include them in the overseas inspections in 2017.

　　II. Main findings in overseas inspections

　　Among 7 varieties that have been inspected, three varieties failed, and the failure rate was slightly increased compared with previous years. 117 deficiencies have been identified in the inspections, of which there were 3 critical deficiencies and 18major deficiencies. The problems mainly focused on Quality Control and Quality Assurance, Material System and Change Management; and critical deficiencies were mainly the problems in the consistency of production process and data integrity. All issues found in overseas inspection have been dealt in accordance with the law.

　　Main and serious problems were as follows:

1. Actual production process and production site was inconsistent with those in registration application and major changes were implemented without submitting application in China.

2. There were significant problems in data integrity, which serious affected the product quality.

3. There were an increasing number of varieties handled by off-site inspection.

Part VI GSP unannounced inspection

　　I. Overview of Inspections

　　In 2016, China Food and Drug Administration conducted centralized remediation on illegal distribution behaviors in drug circulation field, further reorganized and regulated drug circulation order through self-inspection and rectification by enterprises, supervision and inspection by provincial administration and unannounced inspection by CFDA and cracked down illegal distribution behaviors. Throughout the year, 3 batches of inspections have been conducted on 53 pharmaceutical wholesalers. The results of unannounced inspections were announced by CFDA.

　　The teams of inspectorates conducted unannounced inspection on relevant enterprises based on the Announcement of CFDA on Remediating Illegal Distribution Behaviors in Drug Circulation Field (2016 No.94) and Good Supply Practice for Pharmaceuticals. It was identified in the results that the violations were very common in drug circulation enterprises, and the situation was as follows.

　　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