Quality Systems

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

Articles

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

Specialty pharmaceutical company, Diurnal, has announced that the marketing authorization application (MAA) for Chronocort has passed validation with the European Medicines Agency (EMA).


MAA for Diurnal’s Chronocort Passes EMA Validation Stage

Sean Milmo is a freelance writer based in Essex, UK.

Regulatory emergency planning has been put to the test with the COVID-19 pandemic.


Learning Lessons in Crisis Management

Felicity Thomas is Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

As COVID-19 rapidly spreads, the bio/pharma industry is committing significant efforts to fast track development of therapies.

Making Every Effort

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

In light of the current COVID-19 pandemic, the agencies co-chaired the first global regulators meeting to facilitate development of vaccines against SARS-CoV-2, which causes COVID-19.

FDA, EMA Collaborate on SARS-CoV-2 Vaccine Development

The Pharmacovigilance Risk Assessment Committee (PRAC) of EMA has recommended that women stop taking 5-mg ulipristal acetate (Esmya and generic medicines) for the treatment of uterine fibroids while a safety review into potential liver injury risk is performed.

PRAC Recommends Suspension of Ulipristal Acetate for Uterine Fibroids

Following reports, that are particularly circulating social media, questioning whether non-steroidal anti-inflammatories (NSAIDs), such as ibuprofen, worsen COVID-19, the European Medicines Agency (EMA) has issued advice.


EMA Issues Advice on Using NSAIDS for COVID-19

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

Regulatory/GMP Compliance, Europe