Initially the validity of GMP certificates for manufacturing sites of API’s located outside the Economic European Area (EEA) was automatically extended until the end of 2023 without the need for further action from the holder of the certificate due to the pandemic crisis. The EEA authorities have now announced another extension until the end of 2024.
 
Here, the link to the official EMA announcement:  EUDRA website.

Partnership Will Provide Pharmaceutical Grade Cannabinoid Active Ingredients to the Largest Pharmaceutical and Consumer Goods Names in the Industry
​22nd Century Group, Inc., a leading biotechnology company dedicated to improving health with reduced nicotine tobacco, hemp/cannabis and hops advanced plant technologies, today announced filing of a U.S. Drug Master File (DMF) to the US Food & Drug Administration (FDA) for cannabidiol (CBD) API from GVB Biopharma, a 22nd Century Group Company. The submission (DMF 037727) demonstrates 22nd Century Group’s absolute commitment to supplying high quality pharmaceutical grade API to the pharmaceutical industry and OTC markets.

​The validity of GMP certificates for manufacturing sites of API’s located outside the Economic European Area (EEA) are automatically extended until the end of 2023 without the need for further action from the holder of the certificate, unless the issuing/supervisory authority takes any action that affects the validity of the certificate.

This automatic extension is applied in the same manner as for certificates of manufacturing sites located within the EU.

​Please also refer to the COVID notification on the official EUDRA website.

Last year we started with “We are going through some difficult times…”. Unfortunately we have to face the truth and state: “it ain’t over yet”. We all need a good portion of optimism for next year and should never give up hope.
 
With many thanks for your trust in us, we wish you, your family and friends a peaceful and happy Christmas and a healthy start into the New Year 2023.

The first “nearly normal” CPHI after the strict pandemic rules took place in Frankfurt, Germany in November 2022. Despite the fact that the pharma community embraced the opportunity to see their partners face-to-face again or for the first time, it was not quite as crowded as in 2019.

Chinas strict Covid policy and Visa issues especially in India prevented many visitors and even a couple of our partners from coming. 

We are all facing challenging times, but it seems that our partners, visitors and exhibitors were very happy to attend a real show with real people again. Talking, discussing and negotiating with peaceful humans from across the globe made us forget the global unrest for three days. Looking at so many happy faces during our Happy Hour made it clear that video conferencing will never replace the “real thing”.