Regulatory Roundup for the Week of January 28, 2013
Jan 29, 2013
By Pharmaceutical Technology Editors
ePT--the Electronic Newsletter of Pharmaceutical Technology
ISPE has updated its ISPE GAMP guidance on testing of GXP systems to help companies efficiently test computerized and software-based systems.
France has asked the European Medicines Agency (EMA) to review third- and fourth-generation combined oral contraceptives to determine if these drugs should be restricted to women who cannot take other combined oral contraceptives. The agency’s Pharmacovigilance Risk Assessment Committee will review the drugs and give its opinion and determine if a EU-wide recommendation is necessary.
EMA has published guidance on preparing and reviewing product characteristic summaries. The guidance outlines the European Commission’s principles on product characteristic summaries.
EMA announced an agreement for collaboration with Israel on industrial standards. The agreement includes “the mutual recognition of the conclusions of GMP inspections, of manufacturing and import authorizations, and of certification of conformity of each batch without rechecking at import.”
The United States Pharmacopeial Convention (USP) has posted a revision bulletin on <232> Elemental Impurities—Limits and <233> Elemental Impurities—Procedures.
FDA has announced its Vaccines and Related Biological Products Advisory Committee Meeting will be held on Feb. 27, 2013. FDA is accepting public participation in the way of written submissions to be made on or before Feb. 20 and oral presentations that can be scheduled for Feb. 27, 2013.
The past six months has seen some major changes to the sterile manufacturing landscape in Europe. There have been a number of exits and acquisitions that have no doubt grabbed headlines, but has anything really changed?