International – WHO recommends risk management plans for high-risk excipients
The World Health Organization (WHO) has released two draft appendices to a recent draft guideline on good manufacturing practices (GMPs) for excipients. The first...
International – WHO issues guidance on nitrosamine controls in drug manufacturing
The World Health Organization (WHO) released draft guidance for comment this month on good manufacturing practices (GMP) for the prevention and control of contamination...
International – ICH M13A BE testing guideline expected to be adopted this summer
The International Council for Harmonisation (ICH) is expected to adopt its M13A guideline on bioequivalence (BE) testing of immediate-release (IR) solid oral dosage form...
International – ICH E2D(R1) Guideline on post-approval safety data: definitions and standards for management...
It is important to establish an internationally standardised procedure to ensure the quality of post approval safety information and to harmonise, where feasible, the...
International – ICH Q12 IWG “Regulatory and Technical Considerations for Pharmaceutical Product Lifecycle Management »
L'ICH Q12 (IWG) "Regulatory and Technical Considerations for Pharmaceutical Product Lifecycle Management" Module 8 Training Material est désormais accessible sur le site web de...
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...
