NMPA Overseas Inspections for Imported Pharmaceuticals

I. Project introduction

According to the regulations of China CFDA, if a drug manufacturer in a country wants to export drugs to China, the drug regulatory department of China CFDA has the right to conduct on-site GMP compliance audit of the drug manufacturer in accordance with China's current GMP standards. Based on the audit results, it is decided whether to allow It imports into China, thus ensuring the safety of Chinese citizens.

Ⅱ, the basis of regulations

1.Drug Administration Law

2.Special Provisions of the State Council on Strengthening the Safety Supervision and Administration of Food and Other Products (Order No. 503 of the State Council)

3.Measures for the Administration of Drug Registration (Order No. 28)

4.Measures for the Administration of Pharmaceutical Production Quality Management Standards Certification (Guo Food and Drug Administration [2011] No. 365)

5.Regulations on On-site Verification of Drug Registration (National Drug Administration Note [2008] No. 255)

6.2011 "Pilot Work Plan for Imported Drugs Overseas Inspection" "Work Procedures for Inspection of Overseas Production of Imported Drugs" (Pilot)

7.2012 "Measures for Inspection and Administration of Overseas Pharmaceutical Production Enterprises" (Draft for Comment) 

Ⅲ, the official brief process

1. First meeting

²  Working language: Chinese

²  First meeting process:

l  Enterprise brief report 20-30mins

l  Inform the company that there will be a simple exchange of 20-30mins at the end of each day of work (or the beginning of the next day)

l  Inform the company about the ways and means of obtaining evidence

2. Go to the production workshop and auxiliary inspection

²  Communicate with the company in advance, and ask the site to see the key process operations as much as possible.

²  In principle, the company should have personnel to demonstrate changing clothes and accompany the whole process to the workshop.

²  Pay attention to hygiene and safety (self and product)

3. Last meeting

²  Exchange the overall evaluation of the company, including good and defective situations.

²  Inform the company that if there is any objection to the defect found, it can be raised.

²  The inspection team will report the inspection report within 30 working days, in Chinese electronic version.

²  The company should rectify the defects found and submit it to the CFDA within the specified time.

²  The company participates in the list of inspectors and positions, and needs to be signed and confirmed.

Ⅳ、Beijing Conley Consulting's services

Based on years of experience in agent import registration and the experience of guiding Chinese companies to pass the new GMP certification, the following services can be provided for the on-site inspection of CFDA for overseas companies:

1.The gap between the overseas production site and the CFDA requirements.

2.China's drug regulatory laws and regulations, China GMP and Chinese Pharmacopoeia training.

3.CFDA overseas inspection GMP on-site inspection coordination and liaison service.

4.CFDA overseas inspection GMP compliance guidance services, providing professional translation.

5.Chinese drug registration, change registration and re-registration agency services.


Ⅰ.Common problem types found in the company being inspected

1.Some enterprises do not research or pay attention to China's drug-related laws and regulations, and do not carry out drug production and quality management activities in accordance with relevant regulations. The existing problems have a major impact on product quality.

²  Not aware of Chinese drug regulations and technical requirements

²  Not equipped with Chinese Pharmacopoeia and other related documents

²  No training on Chinese regulations for employees

2.Some enterprises treat products that are exported to China and export to other countries differently, reduce the cost and quality control requirements of products, and their products have major safety and quality risks.

3.The change was not reported to the drug regulatory authority of China or filed in time.

4.Individual companies refuse and delay inspections for various reasons.

Ⅱ.Inspection of some problems

²  Korean bear, 1 variety rectification review, 1 high-risk variety inspection

²  French Pfizer Fluconazole Injection

²  Germany's Porsche Jiatao Niang, South Korea's CJ, suspended review and approval

Ⅲ.Number and distribution of CFDA overseas inspections from 2011 to 2014