Pharma says EU GDP proposals expensive, supply-chain nightmare

In July, the EU published draft guidelines it said would help prevent falsified drugs from getting into the approved supply chain. Now the pharmaceutical industry is having its say, and it is generally outraged. 

If implemented, logistics and pharmaceutical companies say the rules would dramatically increase supply-chain costs while being virtually impossible to comply with, reports Outsourcing-Pharma.com.

Criticisms were particularly sharp for this proposal.

"Where transportation hubs are utilized in the supply chain, a maximum time limit of normally 24 hours should be set to await the next stage of the transportation route. Where medicinal products are held on the premises for longer than this defined time limit, the hub will be deemed to be acting as a storage site and required to obtain a wholesale distribution authorization. For refrigerated product any storage at a transportation hub for any period of time would require that premises to hold a wholesalers distribution authorization."

Also, products are often at a site for longer--for example, over weekends and holidays--critics point out. In some geographies, trucks are banned on those days.

"These requirements would significantly increase the cost of the medicinal product supply chains," shipper UPS wrote in its response to the EC, according to Outsourcing-Pharma.com.

- check out the story from Outsourcing-Pharma.com
- read the EU draft GDP rules (.pdf)
- and get the responses

Webinar

Using AI and RWD to Uncover Rare Disease Insights, Accelerate Commercialization and Improve Patient Outcomes

Wednesday, March 24 | 2pm ET / 11am PT

Learn how IPM.ai transformed real world data into real world insights to assist Audentes in their development of AT132 for the treatment of XLMTM. The session reviews how IPM.ia and Audentes collaborated to uncover the XLMTM patient population.