When the decentralised procedure (DCP) was implemented in 2005, I was employed by an agency. It was a time of great change in the EU directive and a sense of anticipation accompanied its introduction. Previous to this, there were only two...
The EU directive, as updated in 2005, had many objectives and one of them was to ensure that the agencies harmonised medicines from one county to another. Harmonisation can be seen in several ways but is for the most part divided into two main...
The Biopharmaceutical Classification System (BCS), introduced in 1995, provides a framework for classifying the drug substance based on its aqueous solubility and intestinal permeability. It allows for the prediction of in-vivo pharmacokinetics of...
The legal basis of the application has a profound impact on the extent and nature of the data provided in the dossier and it is therefore of critical regulatory importance.
On 4 July 2013, the European Medicines Agency (EMA) published the ‘Draft concept paper on the need for revision of the note for guidance on manufacture of the finished dosage form (EMA/CHMP/QWP/324350/2013)’ for consultation.
In August 2013, the European Medicines Agency (EMA) updated its pre-authorisation procedural advice for users of the centralised procedure to outline the most common mistakes detected by the Agency during the validation of initial marketing...
The European Medicines Agency (EMA) announced on 31 January 2013 that it had released a draft guideline to revise the agency’s current guideline on biosimilars containing low molecular weight heparins (LMWHs), a type of medical product often used...
Regulatory affairs is a comparatively new profession that developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical...
