Pharmaceutical products and medical devices are among the most highly regulated and most thoroughly tested products in the world. In the UK, the MHRA (Medicines and Healthcare Products Regulatory Agency) is responsible for ensuring that all...
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...
Pharmaceuticals have become one of the most commonly — and most dangerously — counterfeited products, largely because it is so easy for a criminal to make something that looks right but has no — or inadequate — active ingredients. And while this...
In 2011, the anti-piracy consortium Business Action to Stop Counterfeiting Piracy (BASCAP) of the International Chamber of Commerce estimated that the annual cost of counterfeiting and piracy was $775 billion (£463 billion/€561 billion) and is...
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...
In today’s dynamically changing environment, innovation and cost efficiency in drug development is crucial; costs of R&D are growing aggressively with an average investment of $1.3 billion required to successfully initiate a new drug to market...
Haydn Evans is vice president of intellectual property solutions at CPA Global, one of the world’s leading providers of IP management software and services. He works with a range of clients in sectors such as technology, telecommunications...
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...
