Rule is First Step in FDA Effort to Rescue GMPs from the 1970s
POST-1970s DRUG CGMPs begin taking shape with FDA’s first revision in more than a decade. Gone are references to asbestos and certain pre-automation work processes. In are some new provisions that conform to current practices and that harmonize with other nations’ regulations. FDA’s last major attempt to revise the cGMPs, an ill-fated 1996 proposal, is formally withdrawn, clearing the way to further conform U.S. cGMPs with emerging quality systems approaches.
More from Archive
More from Pink Sheet
Swiss authorities have introduced temporary measures that will make it easier for health care professionals to import medicines that are either not authorized or not available in Switzerland, which will particularly benefit pediatric drugs, in light of ongoing shortages.
Both the EU Clinical Trials Regulation and the European Health Data Space Regulation have the potential to improve harmonization and be highly valuable for industry – but the importance of protecting company data will be paramount, a life sciences consultant says.
With review and development uncertainly increasing, "it’s going to take longer for certain targets … to progress to a place where they’ve been derisked enough that big pharma is ready to write a big check," said Andrew Goodman of Paul Hastings.