Regulatory/GMP Compliance, Europe

The Regulatory Affairs Professional Society (RAPS) has released an updated agenda for its forthcoming conference, RAPS Regulatory Conference-Europe 2019.

AstraZeneca and MSD have announced the EC's approval of Lynparza (olaparib) as a monotherapy in the treatment of advanced or metastatic breast cancer.

EC has granted approval of Pfizer’s VIZIMPRO (dacomitinib) as a monotherapy for the first-line treatment of adult patients with advanced or non-small cell lung cancer (NSCLC).

EMA is evaluating the safety of Lemtrada (alemtuzumab) after new side effects were reported.

At INTERPHEX 2019, CEO Richard Johnson highlighted the importance of PDA’s new Asian business unit and outlined the organization’s plans. Data integrity guidance for manufacturing and quality systems will be published by the end of the year, as efforts move into big data and artificial intelligence.

NICE has not recommended the use of Novartis’ Kisqali (ribociclib) in combination with fulvestrant for the treatment of hormone receptor-positive, HER2-negative, advanced breast cancer.

The European Medicines Agency weighs in on the role of regulators in determining added benefits of novel therapies.

From April 1, 2019 non-pharmacovigilance fees that applicants and marketing authorization holders need to pay to the European Medicines Agency (EMA) have increased by 1.7%.

In a keynote session at INTERPHEX 2019, experts will review and debate the issues and present potential solutions for contamination issues in aseptic manufacturing.

Supplier vetting and monitoring-plus comprehensive testing-ensure quality of raw materials.

The European Commission has published a strategy that will form the basis for the European Union’s policy on pharmaceuticals in the environment.

Uncertainty remains around the UK’s departure from the EU, potentially causing irreparable damage to the bio/pharma sector.

ABPI has asked for a temporary ban to be put in place on drug exports by wholesalers to protect the National Health Service (NHS) from potential shortages in a ‘no-deal’ Brexit scenario.

The agency has published a Q&A document to answer questions about what EMA is doing to prevent medicine shortages during Brexit.

The Regulatory Affairs Professional Society (RAPS) has unveiled the details of its inaugural European regulatory conference, RAPS Regulatory Conference-Europe 2019.

Orion Corporation and Bayer have announced the submission of a marketing authorization application to the EMA for darolutamide for the treatment of patients with non-metastatic castration-resistant prostate cancer.

OSE Immunotherapeutics has been granted authorization to commence a Phase I clinical trial for checkpoint inhibitor BI 765063 (previously OSE-172).

The European generics and biosimilars sector is working on the creation of a single pathway to accelerate development of and access to medicines.

Aclaris Therapeutics has been granted a marketing approval from the Swedish Medical Products Agency for ESKATA.

Recipharm has received ISO 45001 certification for its Wasserberg facility in Germany as a result of the facility’s program to enhance sustainability and safety.

The Pharmacovigilance Risk Assessment Committee of the European Medicines Agency has issued a recommendation for the suspension of fenspiride medicines across the whole of the European Union.

The Swiss Agency for Therapeutic Products has begun entering GMP compliance information in the European Union’s EudraGMDP database.

The two countries have been included in the mutual recognition agreement between the EU and US for GMP inspections.

A taskforce evaluated the advantage of using Big Data in the evaluation of the benefits versus risks of medications.

Big data technology company, Aigenpulse, has been granted with International Organization for Standardization (ISO) 9001:2015 and ISO 27001:2013 certification.

Zogenix has submitted an NDA to the US Food and Drug Administration and an MAA to the European Medicines Agency for FINTEPLA.

The final part of the European Falsified Medicines Directive (EU FMD) is to come into force on Feb. 9, 2019, which means that all medicines within the European Union will need to comply with the safety features as laid out by the delegated regulation.

The agency is requiring companies that make sartan blood pressure drugs to review their manufacturing processes due to the problem with impurities.

As we approach the next instalment of Pharmapack Europe, a potentially perilous situation in relation to drug packaging has emerged for pharmaceutical companies should Brexit result in a ‘no deal’ scenario.

Political instability is causing uncertainty in Europe and wreaking havoc with US regulatory timeframes.