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    ICH details milestones reached on guidelines after Athens meeting

    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...
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    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 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...
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    Upcoming ICH guidelines should ease post-approval changes for analytical methods

    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...
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    FDA issues ICH Q12 guidance and others on clinical trials, safety testing and biowaivers

    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(ICH) guideline on postapproval changes for drug products and issued four other final ICH documents and one draft guidance.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 ...
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    Quantitative Benefit-Risk Assessment: FDA Officials Detail Key Considerations

    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...
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    FDA Updates on Two ICH Guidelines

    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...
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    FDA Outlines Policy on Use of Near Infrared Analysis to Test Drug Quality

    New guidance issued by the US Food and Drug Administration (FDA) is intended to help pharmaceutical companies use near infrared (NIR) technology to better ensure the quality of their manufactured drug products. Background The draft guidance, Development and Submission of Near Infrared Analytical Procedures , is focused on NIR analytical procedures, which are used to identify pharmaceutical starting materials, unfinished drugs and finished pharmaceutical products. N...
  • ICH Looks to Clarify 'Key Issues' With E2C Adverse Event Reporting Guideline

    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 ...
  • FDA Releases Guideline Q&A on Nonclinical Safety Studies for Pharmaceuticals

    The US Food and Drug Administration (FDA) has released for comment an extensive question and answer document generated by the International Conference on Harmonisation (ICH) that is intended to clarify many aspects of a 2009 guideline on nonclinical safety studies for pharmaceutical products. The guideline, M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals: Questions and Answers comes just th...
  • ICH Safety Reporting Standard Advanced by FDA

    A month after the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) released new standards on periodic benefit-risk evaluation reporting, the US Food and Drug Administration (FDA) has released a draft guidance document seeking to bring the US into conformity with the standard. FDA's 10 April draft guidance document, E2C(R2) Periodic Benefit-Risk Evaluation Report , seeks to combine and implement t...
  • ICH Releases Additional Guidance on Combination Drug Toxicity Testing

    The International Conference on Harmonization (ICH) released a new Question and Answer document on 11 January that provides additional guidance on ICH document M3(R2) - Combination Drug Toxicity Testing . The new Q&A addresses a series of questions including: how to conducting toxicity testing on combination products with different toxicity profiles clarity regarding testing differences between the European medicines Agency and US Food and Drug Administratio...