EU and EMA


Clinical Evaluation EU-MDR requirements

Clinical Evaluation EU-MDR requirements 
This article provides a brief overview of Clinical Evaluation requirements as described in the European Medical Device Regulation – EU MDR . 
What is meant by the term ‘clinical evaluation’ in the EU MDR? 
The EU Medical Device …

FDA light touch on medical devices for patient self monitoring

PIC/S PE 009-16 update, Part 1 – changes to Annex 13

Historically, the PIC/S GMP Guide has chapters and annexes revised, aligned and corrected to close the gap between the international GMP guidelines and to further develop and harmonise GMP standards. PIC/S PE 009-16 (or version 16) of the Guide, …


TGA Medicinal Cannabis

I’m often asked to clarify the difference between TGA Medicinal Cannabis and EU GMP Medicinal Cannabis, i.e. who is that has the highest “Gold Standard” for Medicinal Cannabis? I suspect this has come about because many are trying to …


Pre-use Post Sterilisation Integrity Testing – PUPSIT

What is Pre-use Post Sterilisation Integrity Testing (PUPSIT)?
PUPSIT stands for pre-use post sterilisation integrity testing. PUPSIT is performed once your sterilising filter is installed to ensure that the sterilisation and installation process has not damaged your sterilisation filter prior …


Medical Device Regulation (MDR) – 11 Key Changes

The EU Medical Device Regulation (MDR) was the most significant regulatory change in Europe in over 20 years.

The MDR entered into force in 2017 with a three-year transition period.*
The MDR replaced the Medical Device Directive 93/42/EEC and …

fake cannabis medications in australia

Counterfeit Medications | Global Statistics | Australia Risks

Counterfeit medicines — fake drugs and falsified medicines — are endangering lives.
How large is the problem of substandard medications and falsified pharmaceuticals? What are the global statistics of counterfeit medications entering countries across the globe?

And how many fake …

Brexit impact on the MHRA?

Brexit impact on the MHRA?

Brexit causes questions to arise as to the future of the EMA, located in Canary Wharf, London and also about MHRA’s continued contribution to the regulatory control of drugs in the European Union (EU) following the recent Brexit, referendum …


Fading thermal paper – an indelible record?

The practice of making true copies of thermal paper.
Last week I was asked an interesting question relating to making true copies of thermal paper. We all copy thermal paper but the question was: ‘Where does it say that in …


EU releases Annex 15 validation and qualification

On the 30th of March, the EU released its updated version of Annex 15 Qualification and Validation which will be effective on 01 October 2015. In this article, I will discuss the changes between the draft version and the revised Annex 15 version.