Regulatory/GMP Compliance, Europe

The success of virtual GMP inspections performed during the pandemic may lead to more flexible opportunities in the future.

HMA and EMA have released a joint statement on the appropriate route for companies to submit marketing authorization applications and the approval processes for vaccines.

The agency’s safety monitoring plan outlines how information that emerges after the authorization of COVID-19 vaccines will be collected and reviewed.

The guidance was published in connection with a safety monitoring plan for COVID-19 vaccines.

The agency marked the annual European Antibiotic Awareness Day with the launch of a social media campaign highlighting the prudent use of antibiotics.

Experts examine the role technology can play in quality programs at the 2020 Bio/Pharma Virtual Congress.

The document provides analytical strategy options for the control of recombinant viral vectored vaccines to support COVID-19 vaccine developers.

An optimal engineering design is crucial for aseptic operation and cleaning.

Bio/pharma continues preparations for a no-deal scenario as time for the UK and EU to agree upon a new deal runs out.

The agency is balancing a variety of important issues including the review of COVID-19 vaccines.

Industry wants clarification on compliance following the end of the Brexit transition period.

The agency published clinical data on remdesivir and information about COVID-19 treatments that have received scientific advice or informal guidance from EMA’s pandemic Task Force.

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

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

The UK's MHRA has joined the Australia-Canada-Singapore-Switzerland (ACSS) Consortium of regulators.

The agency sent an open letter to European Ombudsman Emily O’Reilly affirming the agency’s intention to apply the same standards to the evaluation of COVID-19 treatments as it does to other medicines.

A comprehensive rewrite of Annex 1 has been proposed and aims to organize and structure requirements in 10 specific sections.

Regulatory bodies are adapting to new ways of working to cope with the impact of COVID-19.

The European Medicines Agency has started a rolling review of AstraZeneca’s COVID-19 vaccine.

Symbiosis has successfully completed a scheduled inspection by MHRA.

ISPE has released new guidance on the cleaning validation lifecycle, written by a group of experts and reviewed by regulators and practitioners.

The agency’s human medicines committee is endorsing the use of dexamethasone in COVID-19 patients requiring oxygen therapy.

The EMA recommendations include a meningococcal vaccine and the biosimilar Nyvepria.

GenSight Biologics has submitted a marketing authorization application to the European Medicines Agency for Lumevoq.

Imfinzi has been granted approval in the EU for the treatment of adults with extensive-stage small cell lung cancer.

Despite pharmacovigilance legislation being in place for nearly a decade, many companies are still struggling to fulfill obligations.

The 2020–2025 EMRN strategy will be regularly reviewed over the coming five years to accommodate science and technology advances.

The agency is reviewing an application for Dexamethasone Taw for treating adult patients with COVID-19.

The UK's MHRA will resume on-site risk based GxP inspections from September 2020.

The European Medicines Agency recently approved two European Novartis sites in France and Switzerland for the commercial manufacturing of chimeric antigen receptor T-cell cell therapies.