US pharmaceutical industry groups endorsed the major principles of the International Council for Harmonization’s (ICH) Q5A(R2) guideline on viral safety of biotechnology products but said it could be improved by incorporating continuous manufacturing principles and clarifying materials testing recommendations.   These comments were made in response to FDA’s release of the Q5A(R2) guideline for public comment in November 2022. The deadline for comments was 13 January....

A top US Food and Drug Administration (FDA) official touted the benefits of cloud-based regulatory submissions in ensuring consistent product reviews and explained how the agency is moving towards this platform through ongoing internal and international harmonization initiatives at a 30 November symposium on drug master files (DMFs) and structured data submissions.   Lawrence Yu, director of the Office of New Drug Products (ONDP) in the Pharmaceutical Quality (OPQ) at ...

The International Council for Harmonisation (ICH) announced that “excellent progress” has been made over the past year in advancing guidelines in the areas of pharmaceutical quality, safety and efficacy, including the adoption of the widely awaited guideline on continuous manufacturing (CM).   These achievements were announced on 22 November following its meeting held in Inchon, South Korea. The meeting was held in parallel with meetings of ICH’s ten working groups and...

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 late-stage pre-approval or post-approval studies when the safety of a drug is well-understood.   In a separate development, ICH announced that its draft Q5A(R2) guideline on analytical testing of biotechnological products to ensure product safety has been released for consultation.   ICH E19 descr...

Pharmaceutical industry groups praised certain aspects of the International Council for Harmonisation (ICH) draft Q14 and Q2(R2) guidelines yet had questions on how enhanced knowledge on analytical methods should be conveyed in regulatory submissions and whether smaller companies would have the necessary resources to invest in the enhanced approach in Q14.   Other groups had questions related to the use of multivariate modeling in analytical method development. In addi...

The International Council for Harmonisation (ICH) announced it has reached several milestones over the past year, including advancing guidelines on validating analytical procedures for testing pharmaceuticals and extrapolating adult clinical trial data to the pediatric populations.   The ICH announcement follows its 21-25 May meeting in Athens, Greece which was held in a hybrid format. The meeting included seven working groups, as well as the ICH Management Committee...

The International Council for Harmonization (ICH) on Thursday issued two draft guidelines that should make it easier for manufacturers to switch analytical methods for testing medicines postapproval and are aimed to promote more robust analytical processes.   The Q14 guideline would harmonize the scientific approaches for analytical procedures development while the Q2(R2) document covers the validation principles for the use of analytical procedures such as near-infrar...

Two forthcoming guidelines from the International Council on Harmonization (ICH) should make it easier to switch analytical methods for testing medicines post-approval and better manage lifecycle changes, said regulators and industry officials speaking Wednesday at the CMC Strategy Forum sponsored by the California Separation Science Society (CASSS).   At the meeting, an official from the European Medicines Agency (EMA) and industry representatives provided a glimpse o...

The US Food and Drug Administration (FDA) on 11 May made available an International Council for Harmonisation’s (ICH) guideline on postapproval changes for drug products and issued four other final ICH documents and one draft guidance.   The ICH Q12 guideline aims to facilitate the management of postapproval chemistry, manufacturing and controls (CMC) changes for new and marketed pharmaceuticals and drug substances and is the same as the version endorsed by ICH as a ...

The US Food and Drug Administration (FDA) is preparing to advance the use of structured benefit-risk assessments in its decision making under its commitments in the recently reauthorized Prescription Drug User Fee Act (PDUFA VI), and agency officials on Monday laid out key considerations for sponsors. Background In 2009, FDA began work to develop a structured approach to conducting benefit-risk assessments as part of an effort to bring more clarity and consistency t...

The US Food and Drug Administration (FDA) on Monday issued updates related to two International Conference for Harmonization (ICH) guidelines, including a revised guideline on the efficacy portion of the common technical document (CTD) and changes to ICH's list for permitted daily exposure (PDE) to solvents. For the first update, FDA issued a draft guidance for public comment in line with ICH's revised guideline on the efficacy portion of the CTD, M4E(R2) – Efficacy , w...

In 2012, the International Conference on Harmonisation (ICH) released a new guideline, E2C (R2) - Periodic Benefit-Risk Evaluation Report , meant to ensure that PBRERs-standardized adverse event reports-contain the information regulators need to evaluate side effects and, if needed, take action. Now ICH is out with an accompanying Question and Answer document on the E2C guideline, a document it says is intended to "clarify key issues" that have cropped up since the ...