Drugs - August 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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