International – Un médicament fait espérer l’éradication de la maladie du sommeil
L’éradication de la « maladie du sommeil » – ou trypanosomiase africaine – serait-elle à portée de main ? C’est l’espoir que suscitent les résultats d’un essai...
International – ICH advances guidelines on selective reporting of safety data, viral safety
The International Council for Harmonisation (ICH) recently announced the adoption of its E19 guideline, which outlines a risk-based approach for collecting safety data for...
International – WHO proposes updated excipient GMPs in wake of contaminated cough syrup
The World Health Organization (WHO) recently proposed updated guidance to assist pharmaceutical manufacturers in assessing the quality of excipients after child deaths were reported...
International – ICH releases draft guideline proposing harmonized bioequivalence testing
The International Council for Harmonisation (ICH) last month released a draft M13A guideline which proposes harmonized bioequivalence (BE) testing of new orally administered immediate-release...
International – ICH guideline S1B(R1) on testing for carcinogenicity of pharmaceuticals Step5
Historically, the regulatory requirements for the assessment of the carcinogenic potential of
pharmaceuticals in the three regions (E.U., Japan, U.S.) provided for the conduct of...
International – Generic industry group wants clarity on ICH bioequivalence guideline
The Association for Accessible Medicines (AAM) said the US Food and Drug Administration (FDA) should ensure alignment between the International Council on Harmonisation’s (ICH)...
International – WHO warns on contaminated cough syrups linked to child deaths
This WHO Medical Product Alert refers to two substandard (contaminated) products, identified in Uzbekistan and reported to WHO on 22 December 2022. Substandard medical...
International – Covid-19 nasal vaccine is here: Price, benefits, all you need to know
Vaccine maker Bharat Biotech's intranasal vaccine for Covid-19, the first in the world, is set to be launched soon and is already available on...
International – Novartis confirms death of 2 children after gene therapy
Novartis has recorded two deaths after treatment with its spinal muscular atrophy gene therapy Zolgensma, once again bringing gene therapy’s safety into attention.
Two children...
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...
