Quality Systems

Articles

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 reporter for Pharmaceutical Technology.

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

Considering Excipient Regulations

AstraZeneca has announced that it has achieved approval in Japan for Lokelma (sodium zirconium cyclosilicate) for the treatment of patients with hyperkalemia (elevated blood potassium levels).


AstraZeneca’s Lokelma Gains Japanese Approval

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

Resources, Guidelines, and Guidance Documents

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

Regulatory and Standard Setting Organizations

Rita Peters is the former editorial director of 

Pharmaceutical Technology, Pharmaceutical Technology Europe

With some FDA inspections on hold, will the US drug supply maintain its quality standards?

A ‘New Normal’ for Quality?

J. Mark Wiggins is owner and compendial consultant with Global Pharmacopoeia Solutions LLC.

Joseph A. Albanese, director of Analytical Strategy and Compliance at Janssen Research and Development, LLC

Monographs are developed based on the submission of information and materials from a company having regulatory approval for the product, and this submission feeds into the pharmacopoeia revision process.

Monograph Development: Why and When to Participate (eBook)

This final article in the series has two purposes: to summarize all the considerations that go into a company’s compendial affairs program and to look ahead at topics that will likely result in further evolution in the pharmacopoeias around the world.

Regulatory/GMP Compliance, Emerging Markets