International – ICH Q14 Analytical procedure development – Scientific guideline
This guideline describes science and risk-based approaches for developing and maintaining analytical procedures suitable for the assessment of the quality of drug substances and drug products....
International – ICH Q2(R2) Validation of analytical procedures – Scientific guideline
This guideline presents a discussion of elements for consideration during the validation of analytical procedures included as part of registration applications submitted within the ICH member regulatory authorities. It provides...
Europe – User guide for micro, small and medium-sized enterprises
This guide has been prepared for micro, small and medium sized enterprises (‘SMEs’) operating in the pharmaceutical sector. Its aim is to facilitate understanding...
USA – Growing interest in modeling prompts launch of MIE program for generic drugs
Officials from the US Food and Drug Administration (FDA) explained how sponsors can increase their chances of getting accepted into the new model-integrated evidence...
UK – MHRA introduces new restrictions for fluoroquinolone antibiotics
From today, fluoroquinolone antibiotics given systemically (by mouth, injection, or inhalation) must only be administered when no other antibiotics are appropriate for use, the Medicines...
UK – Pfizer’s Talzenna recommended by NICE for advanced breast cancer
Patients eligible for the PARP inhibitor will have previously been treated with anthracycline or taxane chemotherapy, or both, unless these treatments are not suitable.
Additionally,...
France – Essais cliniques de médicaments : toutes les demandes de transition doivent être...
Le REC est entré en vigueur le 31 janvier 2022. Il a remplacé la directive 2001/20/CE (transposée en France dans la loi Jardé).
Depuis cette...
Europe – Human medicines: highlights of 2023
The Agency recommended two vaccines to protect against lower respiratory tract disease caused by respiratory syncytial virus (RSV), and the first advanced therapy medicinal product using...
Switzerland – Swissmedic updates guidances on API, fast-track pathway, and more
Swissmedic has made updates to several of guidances related to active pharmaceutical ingredients (API), temporary authorization, products that receive fast-track authorization, and other documents...
UK – Pfizer’s COVID-19 antiviral Paxlovid recommended by NICE for expanded use
A further 1.4 million people with an increased risk for progression to severe COVID-19 will be eligible for Paxlovid following a positive test.
NICE already recommends the...
