Despite being the co-leader and taking the number one or two spots in Warning Letters received with India for the last few years, China had made great strides in obtaining ANDA approvals.   According to an article by Jin Zhang M.D., Ph.D, on PharmaExec.com (here), Chinese firms received 38 ANDA approvals in 2017 (that is 5% of all approvals for the for FY 2017), as compared to 22 in 2016 .  The article outlines each firm’s approvals and details the Chinese leaders in the ANDA approval race.

Just before GDUFA I was placed into effect, I had predicted that the ANDA pipeline from China would become more robust once they better understood the ANDA review and approval process and once firms there became more cGMP compliant.  The path China took is very similar to how India became a huge player in the ANDA market in the 90’s.  It started with India’s massive move into the manufacture and sale of active pharmaceutical ingredients (APIs).  Slowly they then moved into finished dosage forms and now are a major player in the US market for ANDA approvals.  China started the same way and now they are beginning to branch out more into finished pharmaceuticals for the US market.

In a few years, I believe that China may rival India in their ANDA submissions as we are just now really seeing the beginning of a major transition to finished pharmaceuticals.  What does that mean for the Office of Generic Drugs (OGD)?  We all know that FDA underestimated the number of ANDA submissions per year for GDUFA I.  OGD received about 25-30% more ANDA than anticipated, putting a strain on the review and approval process. Under GDUFA II that estimate was raised, but if China cranks up the ANDA submission wheel, the current estimates for iteration II could also be grossly understated.  With the number of players in the Chinese market, we could easily see up to 500 ANDAs/year being submitted from China.

With the push to cut the review cycles by providing interim feedback on ANDA issues during real time review and the 10-month goal clock in play, will OGD be able to continue to meet their goals?  The answer to that is hopefully yes, but at the same time, if that “yes” results in OGD being forced to issue more complete response letters (CRLs) to meet their goals under GDUFA II, then that is a “yes” that I don’t think the industry wants to hear.

Just remember the definition of time: “Time is what keeps one darn thing after another from becoming every darn thing at once.”