Regulatory Update – November 2019

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EMA: Nitrosamine impurities overview 

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BSI UK becomes the second NB designated under IVDR 

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FDA: Type V DMFs for CDER-led combination products using device constituent parts with electronics or software (draft guidance)

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Drug Shortages: Root causes and potential solutions 

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CDSCO: Draft notification for including all medical devices under one rule 

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TGA: Proposed changes to the classification of active implantable medical devices and their accessories – response received 

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TGA: Proposed clarification that certain sports supplements are therapeutic goods 

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FDA: Providing regulatory submissions in electronic format: IND Safety Reports (draft guidance) 

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Danish Medicines Agency’s Data Analytics Center (DAC) 

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Swiss Medic: Adaptation of the guidance document formal requirements HMV4 

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EMA encourages companies to submit type I variations for 2019 by end of November 2019 

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EMA: Overview of comments received on ICH guideline E19 on optimisation of safety data collection 

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FDA: Assessing user fees under the generic drug user fee amendments of 2017 (draft guidance) 

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FDA: Chronic Hepatitis D virus infection: Developing drugs for treatment (draft guidance) 

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TGA: Proposed new medical device classification for substances introduced into the body via a body orifice or applied to the skin 

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TGA: Advertising guidance for providers of disease education activitiesComplying with therapeutic goods advertising restrictions 

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TGA: Consent to supply therapeutic goods that do not comply with subsection 9(2) of Therapeutic Goods Order No. 92 

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EC: First notified body in the Netherlands 

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Tripartite meeting held between the EMA, and FDA and PMDA in Tokyo, Japan to discuss convergence on approaches for the evaluation of anti-infective products 

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Best Practices in drug and biological product post-market safety surveillance for FDA staff (draft guidance) 

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Swiss medic: Revised requirements regarding combination products 

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Finland: Clinical trial documents to be submitted electronically 

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IMDRF: Clinical Investigation 

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IMDRF: Clinical Evaluation 

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IMDRF: Clinical Evidence – Key definitions and concepts 

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ANSM – Fast track clinical trial authorization 

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TGA: Submissions received: Regulation of software, including Software as a Medical Device (SaMD) 

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Medsafe:  Comments on the proposed changes to Paracetamol warning and advisory statements 

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EC: Clinical trial regulations, Q&A updated 

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FDA: Process to Request a Review of FDA’s Decision Not to Issue Certain Export Certificates for Devices 

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EC: Clinical trial regulation 

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EMA: Guideline on clinical investigation of medicinal products for the treatment of gout 

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FDA: Smallpox (Variola Virus) Infection: Developing Drugs for Treatment or Prevention 

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IMDRF: Clinical Investigation 

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EC: Duplicate marketing authorisations for biological medicinal products 

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REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on the national and European Medicines Agency experience regarding the list of medicines for human use subject to additional monitoring 

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Malaysia: DRAFT MEDICAL DEVICE GUIDANCE DOCUMENT 

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WHO: GUIDELINE ON DATA INTEGRITY (draft for guidance) 

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FDA: Transdermal and Topical Delivery Systems – Product Development and Quality Considerations 

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FDA: Product-Specific Guidance for Generic Drug Development 

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Health Canada: Medical Devices Directorate 

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FDA: CERTIFICATES OF CONFIDENTIALITY (draft guidance) 

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FDA: CDRH Unveils Pilot Project for Sterilization Changes 

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Malaysia: NOTIFICATION OF LISTING FOR ORPHANED MEDICAL DEVICE 

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ICH: Updates from Singapore meeting 

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