Medical Device Regulation (MDR) – 11 Key Changes
|

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 several other directives. As of 26 May 2021, compliance with the MDR is now mandatory for…

Counterfeit Medications | Global Statistics | Australia Risks
| | | | | | | | |

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 medicines are entering Australia’s pharmaceutical supply chains? Once primarily seen in low-income regions, the phenomenon…

Water for Injection (WFI) by non-distillation technologies from April 2017 – Ph. Eur.
|

Water for Injection (WFI) by non-distillation technologies from April 2017 – Ph. Eur.

RO Water for Injection? Allowed by the European Pharmacopoeia from April 2017? The European Pharmacopoeia Commission recently announced the revision of monograph 0169 to allow for generation of EP Water for Injection (WFI) “by a purification process equivalent to distillation such as reverse osmosis, coupled with appropriate techniques”. These changes will align the EP with the…