Europe – Annex 1 implementation strategies: Experts say manufacturers must grapple with PUPSIT
Sterile drug manufacturers should start preparing a gap analysis to identify what needs to be done to comply with the EU’s GMP Annex 1...
Europe – Adapted vaccine targeting BA.4 and BA.5 Omicron variants and original SARS-CoV-2 recommended...
EMA’s human medicines committee (CHMP) has recommended authorising an adapted bivalent vaccine targeting the Omicron subvariants BA.4 and BA.5 in addition to the original...
UK – MHRA launches new conflicts of interest code of practice for independent advisors
The Medicines and Healthcare products Regulatory Agency (MHRA) is introducing a new, single code of practice for all its scientific advisory committees, to ensure...
Europe – COVID-19 vaccines safety update
The safety of authorised COVID-19 vaccines is continuously monitored, and updated information is regularly provided to the public.
Safety updates outline the outcomes from assessments...
UK – NICE rejects AstraZeneca and MSD’s Lynparza as NHS prostate cancer treatment
NICE has said it is unable to recommend NHS use of AstraZeneca’s Lynparza for some patients with prostate cancer, after failing to reach an...
Europe – European Pharmacopoeia seeking user feedback on use of recombinant factor C for...
General chapter 2.6.32. Test for bacterial endotoxins using recombinant factor C was published in Supplement 10.3 of the European Pharmacopoeia (Ph. Eur.) and came into force on 1 July 2021....
Europe – Ph. Eur. survey for the availability of alternative plasticisers to DEHP in...
Due to a change in the REACH Regulation ((EC) N° 1907/2006) introduced in November 2021, the experts of the European Pharmacopoeia (Ph. Eur.) have...
Europe – New general chapter on implementation of pharmacopoeial procedures published in the 11th...
A new general chapter, Implementation of pharmacopoeial procedures (5.26), has just been published in the 11th Edition of the European Pharmacopoeia (Ph. Eur.). The text was adopted...
Europe – 11th edition of the European Pharmacopoeia now available in print
The 11th Edition of the European Pharmacopoeia (Ph. Eur.) is now available in print version.
This latest edition contains numerous revised and new texts, reflecting...
Europe – ECDC-EMA statement on booster vaccination with Omicron adapted bivalent COVID-19 vaccines
The European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA) have issued a joint statement providing updated public health considerations on the...
