Quality Systems

Articles

The objectives of the new opportunity are to improve the quality and/or use of RWD, promote better understanding of RWE study designs, and develop specific tools to evaluate aspects of RWE generation.

FDA to Support Potential Use of Real-World Data to Generate Real-World Evidence for Regulatory Decision-Making

Adam C. Fisher, Phd, is Director of Science Staff, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, FDA.

FDA backs the benefits of adopting continuous manufacturing, a strategy which has accelerated approval and launch timelines, and its Emerging Technology Program could be a helpful tool.

The Manufacturing Edge on Path to Market

Resources, Guidelines, and Guidance Documents Directory 

Connect with pharmaceutical and healthcare regulatory authorities around the world via this directory.

Regulatory and Standard Setting Organizations Directory

Find links to pertinent regulatory and standard setting resources, guidance documents, and guidelines.

Resources, Guidelines, and Guidance Documents

Regulatory and Standard Setting Organizations

EMA's CHMP has adopted a positive opinion for Dapivirine Vaginal Ring for women in non-EU countries where HIV disease burden is high.

CHMP Adopts Positive Opinion for Dapivirine Vaginal Ring

Global regulatory authorities have published a report describing the aligned positions on COVID-19 vaccine development, which were agreed upon by meeting participants of the second workshop on COVID-19 vaccine development.

Regulatory Authorities have Published a Report on COVID Vaccine Development

R. Christian Moreton, PhD, is vice-president of pharmaceutical sciences at Finnbrit Consulting and a member of Pharmaceutical Technology’s editorial advisory board.

Priscilla Zawislak is global regulatory affairs advocacy manager, DuPont Nutrition & Biosciences

Katherine L. Ulman is principal, KLU Consulting

Luke Grocholl is regulatory affairs expertâpharma food materials, MilliporeSigma

With ingredients sold to multiple markets, excipient manufacturers must understand the different regulatory requirements for pharma vs. food.

Comparison of Pharmaceutical Excipients and Food Ingredient Requirements

Jennifer Markarian is manufacturing editor of Pharmaceutical Technology.

Understanding European GMPs and new rules from China for excipients are crucial for formulating solid-dosage drugs. 

Regulatory/GMP Compliance, Emerging Markets