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Recent Blogs
WHO Responds to Global Rx Dependency Crisis
Over the years, Global Health Authorities have begun to work towards regulatory harmonization. Of course, the World Health Organization (WHO), a special agency of the United Nations responsible for international public health and established in 1948, is often at the forefront of these efforts.
Reed Tech Takeaways from RAPS Euro Convergence
Greetings from Amsterdam! Earlier this month, Sales Development Representative Miriam Kniering represented Reed Tech...
LexisNexis Reed Tech teams up with RegDesk, a leading regulatory information management platform
Horsham, Pa., USA – May 25, 2023The collaboration of the leading providers of Unique Device Identification (UDI) for...
Health Canada Now Requiring Second-Language at Post-Authorization Phase
Effective March 10, 2023, Health Canada changed submission requirements for second-language product monographs for human drugs. This change no longer requires the second language product monograph at the time of submission filing or review. However, both English and French languages need to be on the Drug Product Database (DPD) online and Drug and Health Product Portal (DHPP).
Simplifying Annual Drug Sample Reporting
Pharma manufacturers and authorized distributors need to submit distribution reports electronically in an eXtensible Markup Language (XML) format to comply with the guidance entitled Reporting Drug Sample Information Under Section 6004 of the Affordable Care Act. This guidance fulfills the Drug Sample Transparency Act specification of ACA Section 6004. These amounts must be reported each year by April 1st for the previous calendar year.
LexisNexis® Reed Tech™ and ONIX Life Sciences Expand Strategic Alliance to Guide Pharma Customer to Market Faster
HORSHAM, Pa., February 14, 2023 /PRNewswire/ LexisNexis Reed Tech has teamed up with ONIX, a boutique regulatory...
MoCRA: The Future of Cosmetic Regulations
The Modernization of Cosmetics Regulation Act of 2022 overhauls existing regulations, mandating FDA-established Good Manufacturing Practices for cosmetics manufacturers.
New FDA Requirement: New and Updated REMS Files to be Submitted in SPL Format
As of December 28, 2022, all new REMS (Risk Evaluation and Mitigation Strategy) submissions and all REMS updates will be required to be submitted in SPL (Structured Product Labeling) format per the FDA. This is in compliance with the Final Guidance on REMS issued by FDA in late December 2020. This means that any current REMS registrations will not need to be submitted in SPL until they require updates. There are currently 62 active REMS—58 ETASU (Elements to Assure Safe Use) and 4 basic (non-ETASU.)
Combination Products: Regulatory Requirements and How To Comply
Continue to be at the forefront of regulatory chatter. Our customers, both primarily medical device and primarily pharmaceutical, are regularly coming to us with questions surrounding this topic. Reed Tech answers these questions here in this blog post