FDA's New Guidelines on Pharmaceutical Contaminants
The FDA has released updated guidelines addressing the presence of N-Nitrosamines, a group of impurities found in some pharmaceutical products. These guidelines are part of the FDA's ongoing efforts to ensure drug safety and protect public health by setting acceptable intake levels for these potentially carcinogenic compounds Read moreEMA's Revised Monograph for Propylene Glycol
The European Pharmacopoeia Commission has adopted a revised monograph for Propylene Glycol in response to contamination concerns involving ethylene glycol and diethylene glycol. This revision aims to enhance public health safety by including stringent testing requirements Read moreNew Regulations on Micro Pollutants in Europe
The European Parliament has mandated the removal of micro pollutants from wastewater before its release or reuse. This directive requires significant investment in wastewater treatment facilities, impacting urban areas with over 150,000 residents by 2030, and all critical zones by 2045 Read moreLaunch of EMA's Consultation on Pharmaceutical Process Models
The EMA has opened a consultation on pharmaceutical process models, seeking stakeholder input on regulatory guidance for continuous manufacturing and digital novel technologies. This initiative is part of the Quality Innovation Group's efforts to update regulatory expectations Read moreFDA's Single Inspection Program Pilot
The FDA, in collaboration with international regulatory agencies, has launched the Single Inspection Program (SIP) to streamline GMP inspections of third-country manufacturers. This pilot program aims to reduce the need for multiple inspections and improve regulatory efficiency Read moreJapan Approves Shionogi's COVID-19 Treatment
Japan's Ministry of Health, Labour, and Welfare has approved Shionogi's Xocova, a COVID-19 treatment. This approval marks a significant advancement in the country's efforts to combat the pandemic with innovative therapeutic options Read moreIndia's New Guidelines on Medical Devices
India has introduced new guidelines for medical device regulation to align with global standards. These guidelines focus on ensuring product safety and efficacy while promoting innovation and improving patient outcomes Read moreEMA Updates on Vaccine Working Party Plans
The EMA has published updated work plans for its Vaccine Working Party, outlining strategic goals and projects for 2022-2024. These plans emphasize the importance of vaccine safety, efficacy, and quality Read moreFDA Public Workshop on Accreditation Scheme for Conformity Assessment
The FDA will hold a virtual public workshop on the expansion of the Accreditation Scheme for Conformity Assessment (ASCA). The workshop aims to enhance the understanding and implementation of ASCA among device manufacturers and sponsors Read moreUS FDA's Warning on Device Testing by Third Parties
The FDA has issued a reminder to device manufacturers to independently verify performance testing results conducted by third parties. This reminder underscores the importance of ensuring accuracy and reliability in device testing Read more
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