Regulatory Updates-November 2020

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MHRA: Draft guidance on randomised controlled trials generating real-world evidence to support regulatory decisions

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Philippines FDA: Full implementation of eServices Portal System for License to Operate (LTO) Application of Drug Distributor, Drug Trader, Drugstore, RONPD, CRO and Sponsor

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Philippines FDA: Online cascading and pilot implementation of the FDA RRD portal for the issuance of License to operate (LTO) and Certificate of Facility Registration (CFR) of radiation facilities

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FDA: Potential for False Positive Results with Antigen Tests for Rapid Detection of SARS-CoV-2 – Letter to Clinical Laboratory Staff and Health Care Providers

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EDQM: RECOMBINANT VIRAL VECTORED VACCINES FOR HUMAN USE

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Swissmedic: Adaptation of guidance documents Fast-track authorisation procedure HMV4 and Temporary authorisation of human medicinal products HMV4

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Swissmedic: Changes to the guidance document Product information for human medicinal products HMV4

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Danish Medicines Agency: Whistleblowing scheme of the Danish Medicines Agency

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EMA encourages companies to submit type I variations for 2020 by end of November

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UK MHRA: Using the UKNI marking from 1 January 2021

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UK MHRA: Placing a medical device on the EU market, CE marking for the EU market after the end of the transition period

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FDA: Risk Evaluation and Mitigation Strategy Assessment Summary for Web Posting; Establishment of a Public Docket; Request for Comments

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FDA: Coronavirus (COVID-19) Update: FDA Authorizes First Test that Detects Neutralizing Antibodies from Recent or Prior SARS-CoV-2 Infection

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FDA: Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry

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FDA: Insanitary Conditions at Compounding Facilities Guidance for Industry

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PMDA: Pharmaceuticals and Medical Devices Safety Information

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TGA: Clinical Trial Exemption (CTX) scheme renamed as Clinical Trial Approval (CTA) scheme

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Malaysia Medical Device Authority: New Search System Announcement

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FDA: Regulatory Considerations for Microneedling Products

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FDA: EUA for COVID antibody calls for additional plant oversight

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Swissmedic: Clinical trials on medicinal products – Pandemic by SARS-CoV-2

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UK MHRA: Guidance on minimising disruptions to the conduct and integrity of clinical trials of medicines during COVID-19

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Swissmedic: Potential nitrosamine contamination: request to perform a risk evaluation

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EMA: Pharmacovigilance Plan of the EU Regulatory Network for COVID-19 Vaccines

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EMA: Consideration on core requirements for RMPs of COVID19 vaccines

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EC: Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746

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FDA: Electromagnetic Compatibility (EMC) 2 of Medical Devices (draft guidance)

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FDA: Certificates Of Confidentiality (Guidance for Sponsors, Sponsor-Investigators, Researchers, Industry, and Food and Drug Administration Staff)

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NIH: Promising Interim Results from Clinical Trial of NIH-Moderna COVID-19 Vaccine

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TGA: Post-market review of face masks: ARTG entries subject to market actions

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HSA: Public Consultation on the Proposed Regulation for Cell, Tissue and Gene Therapy Products under the Health Products Act

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TGA: Sponsors advised of transition to eCTD-only

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FDA: COVID-19 Update: FDA’s Ongoing Commitment to Transparency for COVID-19 EUAs

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EMA: Remote pharmacovigilance inspections of MAHs during a crisis situation- Points to consider

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FDA: Product-Specific Guidances for Generic Drug Development

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EDQM: COVID-19 vaccines: release of guidelines critical for co-ordinated independent batch control by EU OMCLs

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EMA: Guideline on the clinical evaluation of anticancer 6 medicinal products

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EC: COMMISSION RECOMMENDATION on the use of rapid antigen tests for the diagnosis of SARS-CoV-2 infection

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HPRA: Guide to Routine Import/Export of Tissues and Cells for Human Application Involving Countries Outside the European Union

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EMA: EMA considerations on COVID-19 vaccine approval

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FDA: Letter of Authorisation – EUA for Baricitinib in combination with Remdesivir

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FDA: Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act (draft guidance)

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FDA: Cross Labeling Oncology Drugs in Combination Regimens (draft guidance)

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FDA: Clinical Drug Interaction Studies With Combined Oral Contraceptives (draft guidance)

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Pfizer And Biontech Conclude Phase 3 Study Of Covid-19 Vaccine Candidate, Meeting All Primary Efficacy Endpoints

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WHO: Good manufacturing practices 6 for investigational products (draft working document for comments)

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TGA: Low levels of contamination with N-nitrosodimethylamine (NDMA)

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Philippines FDA: Pilot Implementation of Food and Drug Administration (FDA) eServices Portal System for Compassionate Special Permit (CSP) Application for Drug Products

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EC: A pharmaceutical strategy for Europe

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FDA: Qualification Process for Drug Development Tools

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FDA: Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program

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ICMRA: Statement on continuation of vaccine trials

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FDA: Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss Second COVID-19 Vaccine Candidate

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