Since 2011, the China Food and Drug Administration (the “CFDA”, formerly known as the SFDA) has conducted oversea inspection on foreign drug manufacturing sites for drugs importing into China (the so-called CFDA on-site inspection).
On Dec 17, 2014, CFDA announced the foreign drug list and their foreign drug manufacturers that need CFDA on-site inspection in 2015.
So, what are these foreign drugs and manufacturers?
How the CFDA inspectors work?
And, what is the judgment criterion for the inspection?
Take it easy. The report that we provide is going to answer the above questions, and more, for you.
What You Will Get
The report includes
- CFDA on-site inspection history in China.
- the list of the imported drugs that need CFDA on-site inspection in 2015.
- a summation of the key elements of the regulation for CFDA on-site inspection in 2015, including purpose and basis of the inspection, inspection content, inspection procedure, judgment criterion for the inspection, specific materials required before inspection, typical problems found during the inspection, how to deal with the result etc.
- Good Manufacturing Practice for Pharmaceutical Products (The new revision) in China which should be complied with during foreign drug CFDA on-site inspection.
This report includes 3 appendices. They include a list of the imported drugs that need on-site inspection in 2015, regulation for inspection of overseas drug manufacturer and Good Manufacturing Practice for pharmaceutical products in China, etc.
Pages: 77 (Including 21 pages of the basic report and 56 pages in the Appendix):
- Table of Contents
- CFDA On-site Inspection History in China
- Measures and procedures of CFDA On-site Inspection
- Department of China FDA On-site Inspection
- Purpose and Basis of China FDA On-site Inspection
- The Content of On-site Inspection
- The Procedure of On-site Inspection
- Specific Materials Required Before Inspection
- During On-site Inspection
- Judgment Criterion
- Deal with the Results
- Main Problems Found in On-site Inspection
- Inspections in China by FDA
- Appendix I: List of the Imported Drugs that Need On-site Inspection in 2015
- Appendix II: Measures for Inspection of Overseas Drug Manufacturer
- Appendix III: Good Manufacturing Practice for Pharmaceutical Products
Contact us to learn more about how we can help you with pharmaceuticals/drugs in China!