“Points to Consider” for herbals
This article was originally published in The Tan Sheet
Quality assurance, personnel/education, building/facilities, equipment, documentation are among issues addressed by European Agency for the Evaluation of Medicinal Products document released May 2. "Points to Consider on Good Agriculture & Collection Practice for Starting Materials of Herbal Origin," prepared by EMEA working group, also offers counsel on proper handling of: seeds/propagation material; cultivation; collection; harvest; primary processing; packaging; storage/distribution. Document carries no legal force as would GMP guidelines, but considerations "should be used as a basis for the establishment of such an appropriate quality assurance system," EMEA group says...
You may also be interested in...
The FDA has published fresh guidance taking a tougher stance on sponsor reasons for needing more time to respond to complete response letters.
Stada has named Yann Brun to become the group’s new head of global development, portfolio, regulatory and business development, replacing Robert Knerr. The move is the latest in a string of key appointments at Stada as the firm builds on a series of acquisitions and deals.
A letter from more than 60 leading public health and medical ethics experts has been sent to Pfizer's CEO Albert Bourla.