China Registration Approval Process for Belviq with Timelines:
1) File Drug Registration Application to Provincial Drug Administration Authority PDAA
2) Formal review by the PDAA and acknowledgement of receiving the Application = 5 Days (1 Week)
3) The Application is sent to the China Food and Drug Administration (CFDA) to review the completeness of application = 30 Days (6 weeks)
4) The application is transferred to the Center of Drug Evaluation (CDE) and the CDE either Notify the Applicant of Deficiencies if it is not complete = 10 Days (2 weeks)
Time process if the Application is complete
5) Technical review report by the CDE = 120 Days (24 weeks)
6) CFDA issues a letter to the Applicant granting Approval = 30 Days (6 Weeks)
Total Process Time needed if the Application is complete = 39 Weeks *****
Time process if the Application is not complete
5) Within 4 to 6 months the applicant should respond with the supplemental information to the CDE = 26 weeks.
6) Technical review report of amended application by the CDE = 40 Days (8 weeks)
7) The CDE issues final opinion
a. If negative the Applicant is refused to proceed.
b. If Positive the Dossier is transferred from the CDE to the CFDA
8) If 7) is Positive the CFDA issues a letter to the Applicant granting Approval = 30 Days (6 Weeks)
Total Process Time needed if the Application is not complete = 49 Weeks *****
Conclusion: The Filing and Approval in China should take between 9 and 12 months.
Here’s a few of the key points from the Call Transcript:
We are pleased that Eisai is now doubling the size of its sales force to approximately 400 representatives across the country, which will increase their reach to 65,000 physicians by the end of the year.
As Eisai increases the BELVIQ sales force, expands reimbursement coverage and executes on their DTC campaign, we believe that BELVIQ is well positioned for steady growth as we move into the New Year.
Beyond the U.S., we’re committed to bringing BELVIQ to other markets worldwide where as the data show, the growing problems of obesity and overweight impact the lives of many. Eisai submitted an application for the approval of BELVIQ in Mexico in March, for Canada in June and plans to submit an application in Brazil around the end of this year.
Regarding our additional collaborations, Ildong has completed a study to evaluate the tolerability and pharmacokinetics of BELVIQ in Korean adults and is planning to submit an application for approval in South Korea around the end of this year.
In addition, CYB is developing its regulatory submission for BELVIQ in Taiwan and will likely also be in a position to submit their application for approval around the end of this year.
Our interactions with Swissmedic continue as we pursue regulatory approval of BELVIQ in Switzerland. We will keep you updated on this process as appropriate.
The commercial opportunities are clear in Japan, China and eventually in the EU. And we believe that Eisai certainly has the capability of materially moving the opportunity forward in all of those markets.
Sentiment: Strong Buy
I was disappointed with the CY news. I was certain we were well ahead of this process and where moving in on a decision date. Clearly I was wrong and have no idea why I was under that impression. I have a feeling some others assumed we were getting close as well being that nobody said I was wrong. OH well everything seems to be coming together now. Sounds like we could also get some other news soon regarding the EU, and maybe a couple more partnerships for BELVIQ to wrap partners for ROW.
Tiger, I was up early myself wondering how long some of the various country's take for approval?? Thanks for the homework assignment already done. Our system needs an overhaul! We fought WW2, built thousands of planes, tanks, jeeps, guns, artillery guns, ships and landing craft and won the World War in less time than it takes to get a drug through the approval process.
If anyone is familiar with Drug Approval process in China it would be a company like Eisai that resides in Japan, people in a neighboring country who understand the Chinese language and culture.