Drugmakers Make Significant Headway in Track-and-Trace Compliance

International – E-labeling and digital transformation in healthcare

This article examines the regulations for electronic labeling (e-labeling) for prescription drugs and medical devices in Japan, Brazil, Singapore, the EU and US, Canada,...

International – ICH adopts guidelines on viral safety evaluation and analytical method development

The International Council for Harmonisation (ICH) announced on 8 November the adoption of its Q5A(R2) guideline on viral safety evaluation of biotechnology products as...

International – ICH releases Q9 training materials on quality risk management

The International Council on Harmonization (ICH) has issued training materials to complement its revised Q9(R1) guideline on quality risk management aimed at assisting the...

International – E6(R3): ICH releases draft of overhauled GCP guideline for consultation

The International Council for Harmonisation (ICH) on Tuesday published the long-awaited draft version of its ICH E6(R3) guideline on good clinical practice (GCP) for...

International – ICH releases draft guidelines on analytical method development

The International Council for Harmonization (ICH) on Thursday issued two draft guidelines that should make it easier for manufacturers to switch analytical methods for...

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...
WHO drafts guidance for pharma supply chain tracking

International – WHO releases key regulatory considerations on AI for health

The World Health Organization (WHO) has published new key regulatory considerations on artificial intelligence (AI) for health to emphasise the importance of establishing the...

International – FDA, EMA officials discuss impediments to cell and gene therapies

The US Food and Drug Administration’s (FDA) top biologics regulator said the use of a  “playbook” or platform approach for developing multiple cell and...

International – ICH signs off on carcinogenicity testing addendum

The International Council for Harmonisation (ICH) recently announced that its S1B(R1) addendum outlining a “weight of evidence” (WoE) approach to assess the human carcinogenic...

International – ICH guideline M13A on bioequivalence for immediate-release solid oral dosage forms ICH...

ICH M13A Guideline is intended to provide recommendations on conducting bioequivalence (BE) studies during both development and post approval phases for orally administered immediate-release (IR) solid oral...

NOS PROCHAINES FORMATIONS