Quality Systems

Articles

CHMP and CMDh have recommended that all marketing authorization holders (MAHs) of medicines containing liposomal drug delivery systems change the medicine name to avoid medication errors.

CHMP, CMDh Recommend a Change in Names of Liposomal Medicines to Avoid Errors

EMA has issued a recommendation that the multiple sclerosis drug, Gilenya (fingolimod), not be used in women who are pregnant.

EMA Recommends Gilenya Not be Used in Pregnancy

Stephen Maddocks is senior pharmacopoeial scientist at the British Pharmacopoeia.

Peter Crowley is principal pharmacopoeial scientist at the British Pharmacopoeia.

MHRA has launched a consultation to gain a greater understanding of the potential application of AQbD in pharmacopoeial standards and the future of medicines standards.

AQbD, the Evolution of Pharmacopoeial Standards?

Felicity Thomas is Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

As drug supply chain security is of paramount importance, could radio-frequency identification solutions provide the optimal solution for pharma companies?

Safe and Sound with Radio-Frequency

MHRA has issued a drug alert for the Emerade adrenaline auto-injector device, as a result of the device’s potential to fail in delivery of the dose due to blockage of the needle.

MHRA Issues Drug Alert for Emerade Adrenaline Auto-Injector Device

Slovakia becomes the final European Union country to be recognized by FDA, and the mutual recognition agreement for inspections of manufacturing sites between the US and the EU is now fully implemented. 

US and Europe Reach Mutual Recognition Agreement Goal on Inspections

Patient consent is potentially tricky for pharma R&D to navigate as a result of new data protection rules in Europe.

Dual Aspects of Informed vs. Explicit Consent in R&D

CHMP of the European Medicines Agency has recommended a change to the European marketing authorization for AstraZeneca’s Forxiga (dapagliflozin) in patients with Type-2 diabetes.


Forxiga Gains Positive CHMP Opinion for Cardiovascular Outcomes

AstraZeneca has revealed that the CHMP of the European Medicines Agency has given a positive opinion to adding a self-administration option for Fasenra (benralizumab).


CHMP Issues Positive Opinion for Self-Administration of Fasenra

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

Will EMA’s draft guideline clarify questions about the assessment of drug device combinations in relation to the EU medical devices regulation?


Regulatory/GMP Compliance, Europe