Quality Systems

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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.

Difficult to Swallow? ABPI Requests Temporary Ban on Drug Exports Amid Fears of a ‘No-Deal’ Brexit

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

EMA Answers Brexit Questions

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

RAPS Prepares to Hold its Inaugural European Regulatory Conference in May

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.


Orion and Bayer Submit Marketing Authorization Application to EMA for Darolutamide

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

OSE Immunotherapeutics Announces Authorization for Phase I Clinical Trial for its Checkpoint Inhibitor

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

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

Europe Pushes for Global Easing of Generics Approvals

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

Aclaris Therapeutics Gains Approval for ESKATA from Swedish Medical Products Agency

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.

Recipharm Gains New ISO Certification Recognizing Sustainability Efforts

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.

EMA Recommends Suspension of Fenspiride Medicines

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

Regulatory/GMP Compliance, Europe