Pursue Agreement with Indian Counterparts to Facilitate Communication and Collaboration

Pursue Agreement with Indian Counterparts to Facilitate Communication and CollaborationMedical products Memorandum of Intent (MOI) with Ministry of Health and Family Welfare (MHFW): This agreement will clarify and facilitate better understanding with relevant counterparts on the purpose and areas of engagement with the India Office. This agreement, usually requested by Government of India (GOI) counterparts, enables communications and interactions to proceed without continued approvals by more senior Ministry officials. This agreement should bring the regulatory agencies closer and begin to build stronger relationships that should allow further sharing of information and possibly lead towards confidentiality agreements. Upon finalization of this agreement, the FDA will pursue better recognition and practice of U.S. regulations.

OIP’s key projects are ongoing but will no longer be tracked in FDA-TRACK. Going forward, on a rotating schedule, the Foreign Offices will summarize their efforts related to outreach, technical assistance, capacity-building, relationship-building, etc. during the Quarterly FDA-TRACK Briefing. The notes from their reports will be documented in the Quarterly Briefing Summary on the FDA-TRACK webpage.

COMPLETED

ON TRACK

A. Draft developed by India Office

9/1/2010

Completed

9/1/2010

B. Submit to Centers for review/clearance

9/15/2010

Completed

9/15/2010

C. Submit to Office of the Chief Counsel (OCC) for review/clearance

10/1/2010

Completed

10/1/2010

D. Submit to India counterparts for review/clearance

10/13/2010

Completed

10/13/2010

E. Quarterly assessment of the status of GOI review/clearance

12/31/2010

Completed

12/31/2010

F. Quarterly assessment of the status of GOI review/clearance

3/31/2011

Completed

3/31/2011

G. Determine necessary follow up if comments not received

6/30/2011

Completed

8/5/2011

H. Revise plan/project as necessary

7/31/2011

Completed

7/12/2011

I. Resubmit to Centers to consider/react to proposed changes (1)

N/A

J. Submit to OCC to finalize (1)

N/A

K. Sign agreement (1)

N/A

(1) Milestones were not completed while this project was tracked in FDA-TRACK.

http://www.fda.gov/AboutFDA/Transparency/track/ucm206185.htmFDA-TRACK Office of International Programs Dashboard