Quality Systems

Articles

The new guidance outlines the approach the MHRA intends to take for products approved or pending in a decentralized procedure or mutual recognition procedures.

MHRA Updates Guidance on Handling of Approved or Pending DCP and MRP

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

FDA is at a pivotal moment because of important gains in medical treatment based on science.

FDA Leaders Seek to Build Public Trust in Science and Gain Support for Regulation

Measure tackles infant formula, cosmetics, diagnostics plus drug development and access. 

FDA User Fee Legislation Advances in Senate

The draft ICH Q9(R1) document details the importance of quality risk management principles.

FDA Publishes Draft Quality Risk Management Guidance

The new draft guidance describes a standards recognition program for regenerative medicine therapies.

FDA Publishes Guidance on Regenerative Medicine Therapies

The European Commission has granted conditional marketing authorization to the Janssen Pharmaceutical Companies of Johnson & Johnson for CARVYKTI (ciltacabtagene autoleucel), a cell therapy for treating multiple myeloma.

J&J Receives EC Conditional Approval for its First Cell Therapy Product for Multiple Myeloma

The agency’s Medicines Shortages Steering Group has adopted a list of critical COVID-19 vaccines and treatments so they may be monitored for potential shortages.

EMA Adopts List of Critical COVID-19 Medicines

Roche has received approval from the European Commission for Lunsumio (mosunetuzumab), the first CD20xCD3 T-cell engaging bispecific antibody for treating follicular lymphoma.

EC Approves Lunsumio, Roche’s Bispecific Antibody for Follicular Lymphoma

FDA has approved GSK’s vaccine for the prevention of measles, mumps, and rubella in individuals 12 months of age and older.

FDA Approves GSK’s MMR Vaccine 

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

EMA has been assigned a formal role in preparing for and managing future public health crises within the EU through the formalization of ad-hoc structures and processes that were employed during the COVID-19 pandemic.

Regulatory Authority Actions