Quality Systems

Articles

EMA looks to focus on mRNA vaccines because their classification depends on the target and/or whether they are obtained chemically or biologically. 

EMA Aims to Develop Guideline for mRNA Vaccines

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

FDA's approval of Leqembi paves the way for wider coverage of the drug by Medicare and establishes a process for further clinical testing and evaluation of treatments for this widespread, debilitating condition

Large Clinical Trial Supports Alzheimer Drug Full Approval

EMA, the European Commission, and HMAs are phasing out the flexible regulations put into place during the pandemic.

Europe Phases Out COVID-19 Flexible Regulations

Full Marketing Authorization has been granted for Novavax’s COVID-19 vaccine by the European Commission.

COVID-19 Vaccine, Nuvaxovid, Gains EU Approval

Feliza Mirasol is the science editor for 

FDA has approved Roctavian (valoctocogene roxaparvovec-rvox), a gene therapy from BioMarin Pharmaceutical for treating severe hemophilia A in adults.

FDA Approves BioMarin’s Roctavian, the First Gene Therapy for Treating Severe Hemophilia A

Ghada Haddad, PhD, is executive director, Global Quality Transformation Global Quality Shared Services & Regulatory Intelligence Merck & Co.

Darshana Patel is an associate director in Global Quality at Merck & Co., Inc.

The degree of formality in a risk management process should be customized to the organization’s particular needs and the risks involved.

Navigating the Formality Spectrum in ICH Q9(R1)

Lei Lei is senior R&D director of Cutia Therapeutics, Shanghai, China, and he was principal scientist of Shanghai Johnson & Johnson Pharmaceutical Company

FDA’s new guidance on in-vitro permeation test studies published in October 2022 gives technical and statistical requirements for conducting these tests to compare topical generic drugs with their reference products.

In-Vitro Permeation Test Data Analysis with MS Excel as per FDA’s Guidance

Mark Lane is vice president of Development Consulting and Scientific Affairs at PharmaLex.

Preparation is essential for regulatory meetings—it not only crystallizes what is needed from the regulators, it helps them better understand the development programme and potential challenges.  

Top 10 Considerations when Meeting with Regulators

Bianca Piachaud-Moustakis is lead writer at Pharmavision, Pharmavision.co.uk.

Changes to PRIME scheme are set to drive greater harmonization across major pharmaceutical markets.

Improvements to EMA’s PRIME Designation Scheme

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

The UK and EU have negotiated a new draft deal for Britain to re-join the Horizon Europe research programme.

Regulatory Oversight and Compliance