IMPLEMENTING ARRANGEMENT 
 

BETWEEN THE 
 

FOOD AND DRUG ADMINISTRATION 
 

OF THE 
 

DEPARTMENT OF HEALTH AND HUMAN SERVICES 
 

OF THE 
 

UNITED STATES OF AMERICA 
 

AND THE 
 

CHINA FOOD AND DRUG ADMINISTRATION 
 

OF THE PEOPLE'S REPUBLIC OF CHINA 
 

REGARDING THE COOPERATIVE MECHANISM OF 
 

REGULATORY STAFF 
 

The Food and Drug Administration (U.S. FDA) of the Department ofHealth and Human 

Services of the United States of America and the China Food and Drug Administration (CFDA) 

ofthe People's Republic of China (hereinafter referred to together as "the Participants"): 

Recalling the Agreement between the Department of Health and Human Services of the United 

States ofAmerica and State Food and Drug Administration of the People's Republic of China 

on the Safety ofDrugs and Medical Devices (the "Agreement") signed on December 11,2007, 

Noting that the U.S. FDA and CFDA share the understanding that the State Food and Drug 

Administration ofthe People's Republic of China (SFDA)was reorganized in 2013, and CFDA 

has become the successor in interest to SFDA ofthe commitments in the Agreement; 

No ting that both Participants share the understanding that, in light ofthe above, all references 

to the State Food and Drug Administration of the People's Republic of China in the Agreement 

are henceforth understood to refer to the CFDA; 

1 
Aiming to identify the scope of activities to be conducted under the Agreement by U .S. FDA 

and CFDA regulatory personnel posted in one another's country; 

Desiring to further set out the framework for exchange of information and documents under 

Article V of the Agreement related to observations and results from inspections offacilities 

that are engaged in manufacturing, producing, processing, packing, testing, holding, 

transporting, distributing, or exporting any Drug (which term, as used throughout this (IA), 

includes active pharmaceutical ingredients, as under the Agreement); 

Recognizing that this lA lays out a means through which each agency can obtain information 

to inform its regulatory decision-making; and 

Realizing that this IA further clarifies the intentions of the Participants under the Agreement 

by which each Participant may save time and costs in meeti ng its statutory requirem ents 

without a reduction ofpublic health and safety or regulatory responsibilities; 

Intend to further implement the Agreement as follows: 

SECTION I INSPECTION A.t~D COOPERATION BY U.S. FDA REGULATORY 
 

PERSONNEL POSTED IN CHINA 
 

1. 	 U.S. FDA intends to continue to conduct inspections in China to assess the compliance 

with re evant U.S . requirements of facilities that are engaged in manufacturing, 

producing, processing, packing, testing, holding, transporting, or distributing any Drug 

intended for export to the United States or its territories . In support ofthese inspections, 

FDA may also collect and analyze product samples. 

2. 	 For other than for-cause inspections conducted by U.S. FDA regulatory personnel 

posted in China, U.S. FDA intends to provide CFDA at least five working days' 

advance notice regarding its intent to inspect and the relevant facil ity's name and 

location. In an effort to promote better understanding of U.S. FDA's inspectional 

programs and techniques, and to promote cooperative efforts to ensure the safety of any 

2 
Drug, U.S. FDA intends to invite CFDA personnel to accompany said U.S. FDA 

personnel on other than for-cause inspections. As appropriate, U .S. FDA may also use 

this process to invite CFDA regulatory personnel posted in the United States to join a 

certain number ofU.S. FDA pharmaceutical inspections in the United States each year. 

3 . 	 U.S. FDA intends to provide CFDA with timely notification regarding manufacturing 

conditions or products that may constitute potential hazards to health or violations of 

applicable U.S. regulations . This notification may include, as deemed appropriate by 

U.S. FDA, the exchange ofredacted recall information, adverse product trends, 
 

warning letters, copies of FDA's Form 483, and information from import alerts. 
 

4 . 	 As appropriate, U.S. FDA intends to provi de, in a timely manner, red acted copies of 

establishment inspection reports from inspections conducted in China and product 

sample results that U.S. FDA deems appropriate. 

5. 	 When CFDA finds a hazard to health, and U.S. FDA concurs wit h this assessment, U.S . 

FDA may, where appropriate, conduct a fol low-up inspection in an expedited manner, 

and provide CFDA with written findings from its inspection. 

6. 	 On an ongoing basis, U.S. FDA intends to provide CFDA information on firms 

registered under the U.S. drug regulatory system, including information regarding 

products firms produce, through electronic databases or information platforms, or 

through hard-copy records where no electronic data exist. 

7. 	 U.S. FDA intends to identify to CFDA a primary point ofcontact for carrying out 

activities under this IA . This point of contact holds primary responsibility for 

communication and coord ination related to inspection notifications; requests for 

inspection reports; and follow-up regarding compliance actions, recalls, alerts, adverse 

event reports, and meetings . 

3 
SECTION II INSPECTION AND COOPERATION BY CFDA REGULATORY PERSONNEL 

POSTED IN THE UNITED STATES OF AMERICA 

1. 	 CFDA intends to continue to conduct inspections in the United States to assess the 

compliance with relevant Chinese requirements of facilities that are engaged in 

manufacturing, producing, processing, packing, testing, holding, transporting, or 

distributing any Drug intended for export to China. In support ofthese inspections, 

CFDA may also collect and analyze product samples. 

2. 	 For other than for-cause inspections conducted by CFDA regulatory personnel posted 

in the United States, CFDA intends to provide U.S. FDA at least five working d~ys' 

advance notice regarding its intent to inspect and the relevant facility's name· and 

location. In an effort to promote better understanding ofCFDA's inspectional programs 

and techniques, and to promote cooperative efforts to ensure the safety of any drugs, 

CFDA intends to invite U.S. FDA personnel to accompany said CFDA personnel on 

other than for-cause inspections. As appropriate, CFDA may also use this process to 

invite U.S. FDA personnel posted in China to join a certain number of CFDA 

pharmaceutical inspections in China each year. 

3. 	 CFDA intends to provide U.S. FDA with time ly notification regarding manufacturing 

conditions or products that may constitute potential hazards to health or violations of 

applicable Chinese regulations. This notification may include, as deemed appropriate 

by CFDA, the exchange of redacted recall information, adverse product trends, warning 

letters, copies of relevant CFDA inspection reports, and information from import 

measures put in place by CFDA. 

4. 	 As appropriate, CFDA intends to provide, in a timely manner, redacted copies of 

inspection reports from inspections conducted in the United States and product sample 

results that CFDA deems appropriate. 

5. 	 When U .S. FDA finds a hazard to health, and CFDA concurs with this assessment, 

CFDA may, where appropriate, conduct a follow-up inspection in an expedited manner, 

and provide U.S. FDA with written findings from its inspection. 

4 
6. 	 On an ongoing basis, CFDA intends to provide U.S. FDA information on firms 

registered under China's drug regulatory system, including infor mation regarding 

products firms produce, through electronic databases or information p latforms, or 

through hard-copy records where no electronic data exist. 

7. 	 CFDA intends to identi fy to U.S. FDA a primary point ofcontact for carrying out 

activities under this IA. This point of contact holds primary responsibility for 

commlllnication and coordination related to inspection notifications; requests for 

inspection reports; and follow -up regarding comp liance actions, recalls, alerts, adverse 

event reports, and meetings. 

SECTION III OTHER PROVISIONS 

This IA does not affect existing arrangements between the Participants, including the 

Agreement. 

Nothing in this IA diminishes or otherwise affects the authority of either Participant to carry 

out its respective statutory functions within its own territory. Additionally, no provision ofthis 

IA restricts either Participant fro m making its own, otherwise permitted inspection of any 

pharmaceutical facility located within the jurisdictional boundaries ofthe other country when 

needed to meet the needs of its own program for the regulation ofpharmaceutical products. 

Nothing in this IA creates binding obligations between the Participants. All activities 

undertaken pursuant to the IA are subject to the availability of appropriated funds, personnel, 

and other reso urces. The terms ofthe Agreement, and all terms herein that are defined in the 

Agreement have the same meanings as in the Agreement. Each Participant is expected to fund 

its own activities under the IA unless the Participants agree otherwise. 

Cooperative activities under this IA may commence upon signature and are intended to 

automatically renew, so long as the Agreement is in force, for successive periods of five (5) 

years unless discontinued by either Participant. A Participant intendi ng such discontinuation 

should endeavor to provide at least sixty (60) days written notification to the other Participant 

5 
prior to the last day ofany given five year period. This IA may be modified by written mutua l 

consent of both Participants. 

Signed in Beija'ra~ on vh.e. t~td()y,ftJw~u:f!'duplicate in the English and 

Chinese languages, both texts being equally authentic. 

FO HE FOOD AND DRUG 

ADMINISTRATION, 

FOR THE CHINA FOOD AND DRUG 

ADMINISTRATION 

--- /s/ --- --- /s/ ---

--- /s/ ---

--- /s/ ---

DEPARTMENT OF HEALTH AND OF THE PEOPLE'S REPUBLIC OF CHINA 

HUMAN SERVICES 

OF THE UNITED STATES OF AMERICA 

6