HOME
> INDUSTRY
SOLUTIONS > CHINESE PRESCRIPTION DRUG
TRACKING
The
recent focus has been on regulations relating to
the Chinese National Essential Drug List (NEDL)
and how it will be applied under a new law.
The new law implements the Chinese
Electronic Drug Monitoring Network to track
prescription drug products. The database is
managed by China Food and Drug Administration
(CFDA) and information exchanged via established
XML. Manufacturers must request serial numbers
for each CFDA registered item code in advance
from CFDA Electronic Drug Monitoring Network
Database (EDMN-DB). Following packaging the
manufacturer activates serial numbers in CFDA
EDMN-DB. Contract packaging reported to
manufacturer who reports to EDMN-DB.
When shipped to warehouse the movement is
recorded in EDMN-DB. Each movement in supply
chain reported as stock in and stock out reports
to the EDMN-DB. Dispensing or patient may verify
item with EDMN-DB.
There are several very
specific requirements for manufacturers and
wholesalers that will be defined based on your
company procedures and business systems.
Projects have
delivered (1) strategy, (2) project roadmap and
plans, (3) User Requirement Specification (URS)
for (a) enterprise serialization, (b) packaging
systems, (c) warehouse/shipping (referred to as
EDGE), and (d) regulatory reporting such as
e-pedigree, (4) contract manufacturer and
logistics provider requirements and governance,
(5) compliance with global regulatory
requirements, (6) functional and design
specifications, (8) business system and
packaging designs and architectures, (9) pilot
planning and scenarios, (10) GAMP based
validation, and (11) vendor selection.
Projects have included solutions involving
serialization, track and trace, electronic
pedigree (e-Pedigree), country traceability
reporting (i.e., Turkish Ministry of Health,
China, etc.), radio frequency identification
(RFID), barcoding and scanning, GS1 electronic
product code information services (EPCIS),
supply chain, warehousing and Electronic Data
Interchange (EDI). Pharma Logic Solutions is a
longstanding Solution Provider for GS1 US
Healthcare.
Strategy, business and
user requirements, designs and implementations
have included solutions from SAP (ECC, SCM, Aii,
OER, Aie), JD Edwards, Oracle (OPSM, OPM),
Manhattan Associates, MAPICS, Acsis
(ProducTrak), Axway, rfXcel, Frequentz, Systech, Optel Vision (TrackSafe, Line
Master, PharmaProof), Cognex, Mettler Toledo,
Seidenader (Körber Medipak), Antares Vision
(Xyntek), Laetus, ROC-IT Solutions, TAKE
Solutions, Uhlmann, Nosco, Werum PAS-X,
Tracelink, Videojet and others.
Contact us to
discuss your needs and contrast the
Pharma Logic Solutions solutions against previous providers to
see why our approach is the
ideal solution. |
