Regulatory Update – June 2019

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EMA:  Combination Products and MDR: Draft Guideline

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WHO: A Framework for Evaluating 3 And Publicly Designating Regulatory 4 Authorities As Who-Listed Authorities

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MHRA: Consultation on The Application Of Analytical Quality By Design (Aqbd) Principles To Pharmacopoeial Standards For Medicines

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Spain Introduces Portal for Electronic Reporting of Medical Device Adverse Events (article in Spanish)

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Switzerland to Publish Pharmacopoeia for Free Online for the First Time (article in French)

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EMA: Questions and Answers Related To Requirements Of Notified Bodies

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US FDA: Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrolment Practices, and Trial Designs

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US FDA: Non-alcoholic Steatohepatitis with Compensated Cirrhosis: Developing Drugs for Treatment

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EMA:  Combination Products and MDR: Draft Guideline

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Health Canada: Notice to stakeholders’ statements on the Investigational use of marketed drugs in clinical trials

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TGA: Change in Schedule Drug Of Paracetamol

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Two Additional Countries to Benefit From EU-US Mutual Recognition Agreement For Inspections

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Ec Selects Four Udi Issuing Entities

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EU MDR: Germany and Ireland Express Concerns

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FDA: Mouse Embryo Assay for Assisted Reproduction Technology Devices

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CDER Conversation: Ensuring That Standardization Does Not Impede Biological Product Innovation

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ANDA Submissions — Content and Format of Abbreviated New Drug Applications

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MHRA Guideline for the Naming of Medicinal Products and Braille Requirements for Name on Label

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FDA: Testing for Biotin Interference in In Vitro Diagnostic Devices

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EMA: Highlights of Management Board meeting: June 2019

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EC Cautions on MDR/IVDR Impact on Device Availability

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FDA Statement on A New Effort To Improve Transparency And Predictability For Generic Drug Applicants

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Health Canada Launches Consultations to Improve The Safety Of Medical Devices

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Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Post-market Surveillance of Medical Devices)

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TGA: Target Processing Timeframes for Compliance Verification (CV) GMP Clearance Applications

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Therapeutic Goods Advertising: Ensuring ‘Natural’ Claims Are Not Misleading

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TGA:  FAQs On Issues Raised by Industry In Relation To Permitted Indications

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EMA: Clinical Trial Regulation

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FDA: Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework-Draft guidance

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Iran & Argentina Join IDRG

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FDA:  Medical Device Adverse Events Report

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FDA: Providing Regulatory Submissions in Electronic and Non-Electronic Format — Promotional Labelling and Advertising Materials for Human Prescription Drugs

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European Commission Expert Panels on Medical Devices And In Vitro Diagnostic Devices

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