International – ICH targets cell and gene therapies, real-world data as topics ripe for...

Officials from Health Canada and the pharmaceutical industry addressed plans to develop harmonized guidelines on cell and gene therapies and on the design of...

International – ICH consults on revised post-approval safety guideline that accounts for digital platforms

The International Council for Harmonisation (ICH) recently announced that its new draft E2D(R1) guideline on post-approval data and individual case safety reports (ICSRs) has...

International – Regulators, industry tout new approach for benefits-risk assessments

Regulators and industry representatives said that a new international guideline for evaluating the benefit-risk profile of new and marketed drugs developed by the Council...

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...
Advice for Management of Clinical trials in relation to Coronavirus

International – WHO decision improves children’s access to safer polio vaccine

Three years after it received its Emergency Use Listing (EUL) and with 950 million doses now delivered worldwide, nOPV2 has been prequalified by the WHO,...

International – The subjectivity of starting materials in the era of harmonization

Regulatory starting materials (RSMs) represent the starting point of drug substance synthesis from which subsequent steps are carried out under good manufacturing practice (GMP)...

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...
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...

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