Eliquent Japan, Inc

Two former FDA senior officials - Donald Ashley and Kalah Auchincloss - have stepped into pivotal new roles within ELIQUENT Life Sciences' Quality and Compliance Practice. Congratulations Don and Kalah!

Eliquent Japan, Inc's latest blog article examines how a new proposal by Japan’s Ministry of Health, Labour & Welfare may impact the system regulating patent infringements for generic and biosimilar drugs before they receive approval. Read the blog article on IQ Central https://lnkd.in/enwDhhRG

Efficient and effective FDA meetings are crucial for any innovator bringing new products to market. In a new ELIQUENT Life Sciences white paper, Tanvi Mehta and Guangyuan Li examine best practices for optimal FDA meetings and share their learnings from FDA's recent public workshop. Read the white paper at https://lnkd.in/e5EEJcNB

Today’s ELIQUENT Insights: Shenggang Wang examines clinical considerations in the development of Antibody-Drug Conjugates (ADCs) and considerations for a successful clinical development program. Read the article: https://lnkd.in/e2q6bcXb

ELIQUENT expert Minghua Liu, Ph.D. is a featured presenter at today's Bioprocessing Summit. Minghua will address CMC Regulatory Trends from the FDA on mRNA Therapies and potential strategies. Learn more about Minghua and ELIQUENT's RNA capabilities at ELIQUENT.com

Today's ELIQUENT Insights: Tanvi Mehta examines a new survey of biopharmaceutical companies showing that drug developers are stepping up efforts to increase clinical trial diversity, but they need more FDA guidance and clarity to achieve diversity goals. Read the analysis at https://lnkd.in/enD6vuzY

This week’s ELIQUENT INSIGHTS: Learn how recent revisions to Japan’s post-marketing surveillance regulations are optimizing the country’s regulatory process. Read the IQ Analysis at https://lnkd.in/e7Yq3msJ

Recent changes to Japan's regulatory requirements for All Case Surveillance (ACS) show progress toward ongoing efforts to address drug lag and streamline Japan's regulatory process. 

Hi, are you on vacation? Many Japanese folks will take a mid-summer vacation in the week of August 11. We've posted a blog article regarding the requirements of ALL CASES SURVEILLANCE in Japan! https://lnkd.in/gyGFvDbr We are a part of ELIQUENT Life Sciences that creates an unprecedented assembly of global regulatory leaders, industry experts, and technical specialists - brought together to bridge the spectrum of regulatory challenges across the product lifecycle. The collective capabilities of the united ELIQUENT team enable a comprehensive approach that delivers integrated solutions to support pharmaceutical, biotechnology, medical device, and combination product companies navigating the complex global regulatory landscape. <Key Amendments to the Q&A> The revised guidelines clarify that insufficient Japanese patient data in clinical trials should not be the sole reason for requiring ACS as part of the approval conditions. Examples where ACS may be reconsidered include:  Cases where, despite limited Japanese trial data, sufficient safety information is available from international trials, and there are no significant ethnic differences in safety concerns.  Cases where similar drugs with the same mechanism of action have established safety records, and consistent safety data is available.    <Background and Implications>...

Hi, PMDA launched a consultation center for the development pediatric and rare disease drugs in Japan. For more details, please take a look at the article below! https://lnkd.in/gTWD9ew2 We are a part of ELIQUENT Life Sciences that creates an unprecedented assembly of global regulatory leaders, industry experts, and technical specialists - brought together to bridge the spectrum of regulatory challenges across the product lifecycle. The collective capabilities of the united ELIQUENT team enable a comprehensive approach that delivers integrated solutions to support pharmaceutical, biotechnology, medical device, and combination product companies navigating the complex global regulatory landscape. Importance of Simultaneous Development: Director Hiroshi Suzuki highlighted the significance of simultaneous development, stating "Promoting simultaneous development of drugs for adult and pediatric populations will increase the number of medications suitable for children. We urge companies to utilize this new consultation framework." Regulatory Support and Fee Exemptions: MHLW's recent notifications urge companies to develop pediatric drug plans along with adult drug development. Additionally, PMDA introduced a mechanism in the 2024 drug pricing reform to offer higher add-on rates for pediatric drugs approved through simultaneous development plans confirmed by PMDA.......