Issue link: https://www.e-digitaleditions.com/i/1101841
8 April 2019 Tablets & Capsules Poland and Slovenia, have been included in the mutual recognition agreement between US and EU regu- lators, allowing the FDA to rely on 22 member states whose inspection results are considered to be at an equivalent level to US GMP inspec- tions. The agreement, which will be operational in all EU member states by July, strengthens US and EU reg- ulators' reliance on each other's inspection expertise and resources. USP announces Generics Access Plan ROCKVILLE, MD—The US Pharmacopeia (USP) announced its Generics Access Plan, which supports the FDA's efforts to encourage devel- opment of new generic medicines to promote competition, help reduce drug prices, and improve patient access to medicine. The plan's goals include developing and updating quality standards; offering training and education for generic manufactur- ers worldwide; and convening regula- tors, industry representatives, patient groups, payers, and healthcare practi- tioners, to identify additional ways to support generics development. Briefly noted… The FDA approved changes to the prescribing information for Pfizer's Chantix (varenicline), a nicotinic receptor partial agonist indicated for use as an aid to smoking cessation treatment, specifying that the drug is not recommended for pediatric patients age 16 or younger because its efficacy in this population was not demonstrated. The product was origi- nally approved in 2006 for adult use. T h e a g e n c y a l s o a p p r o v e d Lonsurf (trifluridine and tipiracil) for adult patients with metastatic gastric or gastroesophageal junction adeno- carcinoma previously treated with at least two lines of chemotherapy that included a fluoropyrimidine, a plati- num, taxane, irinotecan, and HER2/ neu-targeted therapy. It is manufac- tured by Taiho Pharmaceutical, Tokyo, Japan. approach across global regions that would outline key principles that should be used by manufacturers, users, and regulatory bodies when addressing this topic. The paper can be accessed at: ipecamericas.org/refer- ence-center/document-depot. FDA recognizes Polish and Slovenian GMP inspections SILVER SPRING, MD—The FDA co n firm ed th at two add ition al European Union Member States, Atypical Actives," which advocates for appropriate GMPs for certain materi- als used as atypical actives in drug products based on risk assessment rather than on ICH Q7 GMP compli- ance or its equivalent. The paper pro- vides general background knowledge on atypical actives and APIs, typical characteristics and uses of these mate- rials, and current regulatory perspec- tives on the subject from the EU, US, Canada, and Brazil. It also proposes the establishment of a harmonized