We’re sure you all remember that in December of 2017 InsightCity reported that “if you wanted to hold a commercial drug license in China, you had to manufacture the product using only in-house facilities. Yep, no outsourcing of drug manufacturing.” Sounds like us. As an update, this week STA Pharmaceutical, a subsidiary of WuXi AppTec, reported they were the first CMO to get regulatory approval to manufacture a commercial drug in China. For a nice summary of China’s Marketing Authorisation Holder (MAH) program from the Economist, go here. What’s next? Well, if we look into our crystal ball, this has to fully open the doors to increased business for CDMOs, provide flexibility for innovator companies in China, and open the door to smaller innovator companies that couldn’t afford their own manufacturing facilities in China. In essence, we’re talking about a land grab.
At InsightCity, we consider ourselves fairly knowledgeable about the pharmaceutical market. That said, we were a bit taken aback to learn that until July 2016 if you wanted to hold a commercial drug license in China, you had to manufacture the product using only in-house facilities. Yep, no outsourcing of drug manufacturing. In case you didn’t know, using a Contract Manufacturing Organization (CMO) is big business in the US and Europe. China has started a 3-year pilot program called the Marketing Authorization Holder (MAH) System. There was a recent summit to discuss MAH progress and as one might expect, Chinese CMOs are considering themselves quite fortune-ate (too much?). Look for homegrown Chinese CMOs and established western CMOs to start down the joint venture path. Also, 2018 is the year of the Earth Dog in China. Now you know.
If you live in the US, it’s seriali“z”ation. Regardless of how you spell it, track-and-trace is coming. The Drug Supply Chain Security Act train, while delayed a bit, is still thundering down the track (pun intended). You know who hates serialisation? Smaller CMOs. Implementing serialization is expensive and without a massive number of customers over which to spread the cost, some smaller CMOs could be in a world of hurt. According to Tracelink, as many as 400 CMOs will not be ready for upcoming US and EU track-and-trace regulations. And if you can’t afford to be compliant, then perhaps the next step is to consolidate. Looks like this trend is far from over. So, buckle-up sippy cup, get your CMO strategy in line, and enjoy the roller coaster ride.
The clock is ticking on global serialization compliance. (But if you’re behind, don’t feel bad. We thought this article was going to be about breakfast foods.) As the deadline approaches, anyone selling pharmaceutical products into the U.S. will be significantly impacted if their processes do not meet regulatory standards by the end of 2017. Specifically, all products must carry a Global Trade Item Number (GTIN), serial number, lot number, and expiration date. According to Kurt Wieditz, Director/Team Leader Contract Manufacturing at Pfizer CentreOne, “Because initial serialization projects rarely go completely as planned, expect the total endeavor to take approximately 18 to 22 months.” Could be worse. You could be stuck barcoding Fruit Loops. Here’s the Wikipedia history of breakfast cereals.