The Intrigue Contained In The New China Drug Code

The CFDA “Bit Code”

Over the last few weeks, the pharma serialization and tracing landscape has begun to shift in China.  The China Food and Drug Administration (CFDA) announced a new use for an existing “National Drug Code” in Public Notice 2017-1 that, according to Google Translate (a helpful but very imperfect translator), will be referred to as the “Bit Code”.  In addition, a new notice has appeared on the AliHealth-hosted web portal that drug companies have been using for the last seven years or so to obtain serial numbers for their drug packages.  Automated translation tools leave too much to speculation so companies should not use them for compliance purposes.  However, here are my thoughts/speculation on what is happening.  If you do business in China, I recommend you get professional translations and contact the CFDA for clarification.


The new CFDA announcement and associated document from 2009 that describes the China National Drug Code, or “Bit Code” establishes a new requirement for that code.  This 14-digit code is not a GS1 Global Trade Item Number (GTIN), but it is constructed in a way that appears to make it conspicuously interchangeable with a GS1 GTIN on a technical level.  That is, the identifier will fool utilities and applications into thinking they are dealing with a true GS1 GTIN, even though they are not.  I’m sure this is causing some heartburn at GS1, who had lobbied the CFDA to get rid of the old serialized identifier system and replace it with the GTIN and related GS1 standards. 

Like the GTIN-14, the CFDA Bit Code is composed of several fields that identify the locality (China), and the product.

Here is a comparison of the composition of the CFDA’s Bit Code with GS1’s GTIN-14 (see also, “Anatomy of a GTIN”):



CFDA Bit Code

Packaging Indicator Digit

First digit


Locality and company ID

The first subfield within a GS1 Company Prefix (GCP) indicates locality because the first 1 to 3 digits indicate the GS1 Member Organization (M.O.) that issued it.  For the China M.O., those digits would be between “690” and “699”.  These would appear in digits 2 through 4.

The international telephone country code, which for China is “86”.  Since this is the first field within the Bit Code, they take up digits 1 and 2.

Product type indicator


“9” in the 3rd digit indicates the product is a drug.

Company ID

The second subfield within the GCP is a company ID assigned by the M.O.  Because the M.O. ID is variable length, and the overall GCP is also variable length, the company ID can fill anywhere from digits 3-8 to 3-12.  But in China, the M.O. ID is always 3 digits long, so the company ID would run from digits 5-8 to 5-12.

Digits 4 through 8.

Product ID

This is a variable length field whose length is determined by the length of the GCP.  It can run anywhere from digits 9 through 13.

Digits 9 through 13

Check Digit

Digit 14

Digit 14

The reason GS1 applications can be easily fooled by a CFDA Bit Code into successfully treating it like a GTIN-14 is because GS1 has always insisted that applications treat the entire 14-digits as a single code, only stripping out the indicator digit (first digit) and/or the check digit (the last digit) for special treatment.  It’s dangerous to assume anything else.  But if you do that with a CFDA Bit Code, you will think the GTIN Indicator Digit is equal to “8”, which is valid, and because both systems use exactly the same calculation for the check digit, it will always be valid too, if constructed properly. 

Here is where it gets pretty clear that the CFDA has intentionally constructed their Bit Code identifier to fool applications that expect a GTIN, allowing Chinese drug companies to avoid paying GS1 China for a GS1 GCP.  If you look at any CFDA Bit Code for drugs, it turns out that the three digits that would be in the same position as the GS1 Member Organization identifier for China (the first 3 digits of what would be the GCP in a GTIN-14), you will find one of the ten codes that would just happen to indicate the China M.O.:  690 through 699.  Notice that the first digit of this three digit sequence in the CFDA Bit Code is actually the last digit of the International Telephone Country Code for China, the “6” in “86”, and the second digit is actually the Product Type Indicator, “9”, for drugs.  So the first two digits that GS1 fixes for the China M.O. in a GTIN just coincidentally turn out to be fixed with exactly the same values in the CFDA Bit Code.  The third digit of the GTIN M.O. ID would line up with the first digit in the CFDA Company ID field, which can be any digit, 0-9.  Thus, every valid CFDA Bit Code will always contain a valid GS1 China M.O. ID code in the same 3 digits as every GTIN issued under that M.O.  Did I say “coincidence”?

Almost no applications attempt to confirm a 14-digit product identifier is actually a valid GTIN-14 before treating it as one.  The most they would do is confirm that the checksum in the last digit is valid.  Consequently, the Bit Code is technically “interchangeable” with the GTIN-14 as a product identifier.  As a result, you would be able to use these Bit Codes to construct technically valid GS1 linear or 2D barcodes, and maybe even RFID tags (I’ll let someone else analyze that part).  The only problem is, this would violate GS1’s international copyright on the GS1-specific formatting of those barcodes.  Whoops.  Do you think the CFDA cares about that?

I am confident that GS1 will have a way to work around this “unfortunate similarity” and still allow companies to stay within their good graces.  Watch for that to come.


If you have read this far, odds are you will recall that the previous CFDA regulations required drugs to be marked with a linear barcode that encoded a unique serialized identifier.  Those identifiers were obtained from AliHealth—who was apparently under contract with the CFDA—through their DrugAdmin portal.  Prior to this month there were confusing and potentially conflicting indicators that the CFDA had “suspended” those regulations (see “China Adds Traceability Requirement To CFDA Drug Quality Management Specification”, and “China’s Retreat From Pharma Serialization: Will This Become A Global Trend?”).  One of the confusing things about it was that AliHealth’s portal continued to provide new unique serialized identifiers whenever drug companies requested them.  If companies did not need to continue serializing their drugs, why didn’t they shut down their service?

Today, when you use Google Translate to view the main page at, this is what you see:

Notice prominently displayed on Translation by Google Translate.

It looks like they forever intend to provide you with those unique identifiers, but, they will not provide support, and they suggest that business users who use the service should ‘…construct the retroactive system, or choose the third-party retrospective professional service as soon as possible.’  The translation is bad, but doesn’t it appear like they recommend you stop using this old system and start using the new approach to identifying drugs as soon as possible?  The date on this notice is the same as the date of publication of Public Notice 2017-1, January 20, 2017.  Coincidence?

I can’t stress enough that any company who serves the China market must get a professional translation of these documents and notices before taking any action.  Make your own decisions based on facts, not based on my speculative interpretations.