MDR vigilance guidance and GMP regulatory reliance

From guidance to help industry apply new regulations to efforts to streamline core regulatory processes across jurisdictions, the PharmaLex newsletter gives you insights into developments across the life sciences through articles, blogs, webinars and other forums. Read the June newsletter to learn more.  

Vigilance guidance gives clarity on MDR requirements  

The Medical Device Coordination Group (MDCG) has provided updated Device Specific Vigilance guidance to assist manufacturers of specific devices in meeting the European Medical Device Regulations (MDR 2017/745). Find out more about the guidance and how it applies to specific devices.  

Brazil’s Anvisa proposes GMP regulatory reliance for inspection agility   

Brazil’s national health surveillance agency, Anvisa, has issued guidance on regulatory reliance from equivalent foreign regulatory authorities for the GMP inspection and certification processes. Normative Instruction (IN) 292/2024 defines that members of the Pharmaceutical Inspection Cooperation Scheme (PIC/S) and ICH will be considered equivalent authorities.  

Overcoming longevity, scalability and cost challenges with ATMPs 

ATMPs have been transformational for many patients with rare disease. But while there’s huge hope for continued breakthroughs, concerns about longevity of product effect, repeatability of dosing, manufacturing scalability and cost remain. Find out more in our recent article. 

Webinar: Transforming PV and improving patient safety with new technologies 

New technologies are making processes such as safety reporting easier and more accurate - freeing busy safety and clinical teams to do more and enhancing patient safety. Join our expert panel in this exclusive webinaras they examine the current state of pharmacovigilance technologies.