Drugs - August 2017

September 1, 2017

  • EU: Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products – Revision 1, adopted

  • EU: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use topic E 2 B (R3): Questions and answers: Data elements for transmission of individual case safety reports – Step 5, adopted

  • EU: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use guideline M7 (R1) on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk – Step 5, adopted

  • US: Guidance – Generic Drug User Fee Amendments of 2012: Questions and Answers Related to Self-Identification of Facilities, Review of Generic Drug Submissions, and Inspections and Compliance; Guidance for Industry; Availability

  • US: M4E (R2): The common Technical Document – Efficacy; International Council for Harmonisation; Guidance for Industry; Availability

  • US: Institutional Review Board Waiver of Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects; Guidance for Sponsors, Investigators, and Institutional Review Boards; Availability

  • US: Recommendations for the Permitted Daily Exposures for Two Solvents, Triethylamine and Methylisobutylketone, According to the Maintenance Procedures for the Guidance Q3C Impurities; Residual Solvents; International Council for Harmonisation; Guidance for Industry; Availability

  • Canada: Notice – Validation Rules for Regulatory Transactions Provided to Health Canada in the “Non ECTD Electronic- Only” Format

  • Argentina: Circular 5/2017: Access to Unapproved Medicinal Products by Exception

  • Latin America: New ICH E19 Guideline in Development on Optimisation of Safety Data Collection

  • Brazil: Resolution RDC 166: Validation of Analytical Methods

     

     

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