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  • Regulatory NewsRegulatory News

    Pharmaceutical industry groups suggest ICH Q9 changes

    The proposed revisions of the International Council of Harmonization’s (ICH) Q9 (R1) guideline on risk management should be better aligned with medical device quality risk standards as well as international standards. Further, a firm’s information technology (IT) program should be subject to the same level of risk controls as other areas within an organization, representatives of the pharmaceutical industry said in their comments on the update.   The European Medicin...
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    ICH guide provides clarity on estimands, sensitivity analyses

    The International Council for Harmonization (ICH) has issued ICH E9 (R1) training materials meant to improve the planning, design, analysis and interpretation of clinical trials by defining suitable estimands.   The 238-page guide is meant to accompany an earlier addendum that presents a structured framework to link trial objectives to a suitable design; the addendum took effect in 30 July 2020 (RELATED:  ICH E9(R1) and S5(R3) to Take Effect in EU by End of July ...
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    ICH recaps progress made over past year, charts new topics

    The International Council for Harmonisation (ICH) announced that “significant milestones” were reached over the past year, including the adoption of the widely anticipated guideline on general considerations for clinical studies and the release of question-and-answer guidelines related to the electronic Common Technical Document (eCTD).   Other accomplishments ICH cited in a recent summary of a mid-November virtual meeting include the advancement of a guideline on qu...
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    To speed drug development, ICH proposes reducing rat carcinogenicity testing

    The International Council for Harmonisation (ICH) recently announced a new draft guideline that proposes a “weight of evidence” approach to inform whether a two-year rat study would add value in evaluating a drug’s carcinogenic risks.   The proposed guideline provides more detailed guidance for drug developers who are considering whether rodent studies are needed to assess carcinogenicity. The ICH S1B(R1) addendum, once adopted, should be used in conjunction with the I...
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    FDA Opens for Comment Revised ICH Guideline on Statistical Principles for Clinical Trials

    The US Food and Drug Administration (FDA) on Monday opened for comment a newly revised International Council for Harmonisation (ICH) guideline intended to better align the choice of statistical methods with questions of regulatory importance, and to improve the reliability of decisions about and representations of the effects of medical products. The 31-page draft guidance, according to FDA, clarifies, updates and extends the earlier ICH guidance, entitled "E9 Stati...
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    ICH Plans Work on Clinical Trials Guideline Revision, Pediatric Extrapolation

    The International Council for Harmonisation (ICH) is planning to take up two new topics, according to the minutes released Thursday from the group's meeting in Montreal in May and June. The two topics include the first revision to ICH's 1997 E8 General Considerations for Clinical Trials and a new guideline on pediatric extrapolation in clinical trials, both proposed by the US Food and Drug Administration (FDA). The ICH Assembly also adopted concept papers outlines f...
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    ICH Offers Reflection Paper on Good Clinical Practice Revisions

    The International Council for Harmonisation (ICH) on Thursday opened for comment a new reflection paper on Good Clinical Practice (GCP), part of a plan to modernize ICH guidelines on clinical trial design, planning, management and conduct. The scope of the revisions includes the current E8 General Considerations for Clinical Trials and further revision to the E6 Guideline for Good Clinical Practice , which is already undergoing modernization with the recent de...
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    ICH Advances Three Guidance Documents

    The International Council for Harmonisation (ICH) earlier this week announced the advancement of two guidelines to Step 4, or the implementation period of its process, and one question and answer document on the development and manufacture of drug substances to Step 2b of its process, meaning it enters a consultation phase. On the Step 4 front, the Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice (GCP) advanced. “The current amendment (ICH E6(R...
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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...
  • FDA Releases Final ICH Guidance on Genotoxicity Testing and Data Interpretation

    The US Food and Drug Administration (FDA) announced it has released new, harmonized guidance for sponsors looking to conduct genotoxicity testing and data interpretation for human drug products. The guidance, originally put forth in 2008 by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), combines and replaces two existing ICH guidance documents: S2A Specific Aspects for Regulatory Genotoxic...