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  • Regulatory NewsRegulatory News

    Drug mutagenicity, proarrhythmic potential addressed in pair of FDA guidances

    The US Food and Drug Administration (FDA) has issued two new draft International Council on Harmonisation (ICH) guidelines for public consultation.   A question-and-answer (Q&A) guidance on clinical and nonclinical evaluation of QT/QTc interval prolongation and proarrhythmic potential of medicines was published in draft form by FDA on 29 September; the guidance is currently in ICH Step 2b, awaiting consultation from the Council's participating countries. The draft guid...
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    ICH updates: E14 consultation, Health Canada implements M9 guideline

    The International Council for Harmonisation (ICH) on Thursday announced its E14/S7B draft questions and answers guideline on clinical and nonclinical evaluation of QT/QTc interval and proarrhythmic potential has reached Step 2b of the ICH process.   On Friday, the European Medicines Agency (EMA) opened a three-month public consultation to gather feedback on the document. ICH will also be hosting a two-day public meeting to provide a high-level overview of the docum...
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    ICH Reverts to Previous Version of Guideline on Residual Solvents

    The International Council for Harmonisation (ICH) has further explained why it decided to go back and change the Permissible Daily Exposure (PDE) for ethylene glycol (EG), and then more recently, to reverse that decision and revert back to the original figure. Prior to 2017, the ICH Q3C guideline, which deals with residual solvents, included a Summary Table 2 that listed EG as a Class 2 residual solvent with a PDE of 6.2 mg/day. But in 2017, ICH was notified by an exter...
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    ICH Adds Four New Regulatory Observers

    Regulators from Argentina, Israel, Jordan and Saudi Arabia were recently approved by the International Council for Harmonisation (ICH) Assembly as Regulatory Observers. The approvals came at a meeting from 1-6 June in Amsterdam. ICH said the meeting was its largest biannual meeting ever and that progress was made on existing guidelines, training materials to support guideline implementation, the details of an ICH meeting in Silver Spring, MD, on 31 October on the revisi...
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    Health Canada Implements ICH Guideline on Good Clinical Practice

    Health Canada said Wednesday that it has implemented the International Council for Harmonisation’s (ICH) guideline on good clinical practice, known as E6(R2). While working to eliminate the differences between its own and ICH guidances, Health Canada said that in cases of such discrepancies, Health Canada-implemented ICH guidances should take precedence. The decision to implement the guideline in Canada follows the work of its ICH peer regulatory agencies to implemen...
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    ICH Advances Revised Guideline on Elemental Impurities

    The internationally harmonized guideline for a risk-based approach on assessing and controlling elemental impurities in drug products entered the final implementation phase. ICH Q3D(R1) Guideline for Elemental Impurities, developed via the International Council for Harmonisation (ICH), reached the fourth out of five steps in ICH’s process of regulatory harmonization last week, moving toward implementation of the revised guideline. The guideline was first recommended for...
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    EMA Opens for Consult ICH M10 Guideline on Bioanalytical Method Validation

    The European Medicines Agency (EMA) on Thursday released for public consultation the International Council of Harmonisation’s (ICH) M10 guideline, which aims to help sponsors improve the quality and consistency of bioanalytical data in support of the development and approval of both chemical and biological drugs. The 57-page guidance, which has been in the works since 2016, provides recommendations for the validation of bioanalytical assays for chemical and biological d...
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    Vanda Pharmaceuticals Sues FDA Over Partial Clinical Hold

    In a complaint filed against the US Food and Drug Administration (FDA), Vanda Pharmaceuticals called on a federal district court to lift a partial clinical hold on its experimental drug tradipitant. The complaint—filed with US District Court for the District of Columbia on Tuesday—alleged that FDA acted in violation of the Administrative Procedure Act of 1946 (APA) in imposing the partial clinical hold last December. The hold was imposed on a protocol for a new clinic...
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    ICH Seeks to Harmonize Generic Drug Standards

    With an aim to harmonize the technical and scientific standards for generic drugs across borders, the International Council on Harmonization (ICH) on Wednesday released a reflection paper outlining an approach to begin supporting such efforts. The reflection paper offers recommendations to develop a series of ICH guidelines on standards for demonstrating bioequivalence for non-complex and more complex dosage forms and products. It also describes the remit of the Informa...
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    FDA Offers ICH S11 Guidance for Comment as Shutdown Threatens Further Guidance

    The US Food and Drug Administration (FDA) on Tuesday issued draft guidance, developed by the International Council for Harmonisation (ICH), on the standards for nonclinical safety studies in the development of pediatric medicines. The 38-page guidance should be consulted for study design, and early consultation is recommended for consideration of nonclinical support for pediatric medicine development. The guideline lays out advice on determining the need for additional ...
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    Industry Comments on ICH Product Lifecycle Management Guideline

    The European Medicines Agency (EMA) on Friday released comments gathered during its public consultation for the International Council for Harmonisation's (ICH) draft guideline on pharmaceutical product lifecycle management.   The 31-page draft guideline , ICH Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management , was adopted by ICH and released for public consultation last year.   Most of the comments EMA received express...
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    ICH Updates on Guidelines, Future Topics

    The International Council for Harmonisation (ICH) on Friday said it has made “significant progress” on new and existing guidelines following a weeklong meeting in Charlotte, North Carolina earlier this month.   ICH also said it has finished implementing the reforms set out in 2015 to make the organization more global.   “Three years on from the reform of ICH, all organizational changes have been implemented,” ICH writes, noting that its membership has grown to incl...