29. May 2023 Regulatory Roundup
Martin King
✅𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗔𝗳𝗳𝗮𝗶𝗿𝘀 & 𝗤𝘂𝗮𝗹𝗶𝘁𝘆 𝗔𝘀𝘀𝘂𝗿𝗮𝗻𝗰𝗲 𝗘𝘅𝗽𝗲𝗿𝘁 | Open to New Challenges | Medical Device, IVD | Navigating FDA, IVDR, MDR, PRRC | ISO Lead Auditor | 𝙢.𝙠𝙞𝙣𝙜@𝙗𝙡𝙪𝙚𝙬𝙞𝙣.𝙘𝙝
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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10 - 12 May 2023
Global Health Framework: working together towards a healthier world
As the Integrated Review Refresh 2023 states, this refreshed Global Health Framework sets out the UK’s continued commitment to global health efforts. The framework harnesses capabilities across government towards our global health aims, as set out in the set out in the International Development Strategy.
The Global Health Framework seeks to maximise the combined impact of our investments, innovation and engagement with important partners around the world on a bilateral and multilateral basis. It also aims to maximise impact working with global partners from industry, academia, funders, and civil society organisations to shape global policy and health outcomes. The Framework ensures that we are using our resources as effectively as we can to meet our objectives in a fully joined-up way.
This Framework sits alongside:
•Health Systems Strengthening position paper setting out how we will help build strong, resilient and inclusive health systems
•Ending Preventable Deaths of Mothers, Babies and Children approach paper setting out how we will meet our commitment to do this by 2030
Contents
Therapeutic Goods Administration Australia
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Arrangement under subsection 7C(1) of the Therapeutic Goods Act 1989 for use of computer programs to make decisions under sections 61(3)(a), 61(5AA), and 61(5AB) of the Act
Arrangement under subsection 7C(1) of the Therapeutic Goods Act 1989
This instrument is made under subsection 26BD(3) of the Therapeutic Goods Act 1989.
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Arrangement under subsection 7C(1) of the Therapeutic Goods Act 1989
Arrangement under subsection 7C(1) of the Therapeutic Goods Act 1989 for use of computer programs to make decisions under sections 41FDB, 41FF and 41FH of the Act
Arrangement under subsection 7C(1) of the Therapeutic Goods Act 1989 for use of computer programs to make decisions under sections 61(3)(a), 61(5AA), and 61(5AB) of the Act
Phase out of ISO 13485 certificates for IVD medical devices
The transition period for the TGA to accept ISO 13485 certificates as manufacturer evidence for in vitro diagnostic (IVD) medical devices ends on 26 May 2023.
This means we can no longer accept ISO 13485 certificates to support IVD inclusion applications.
Approved IVD medical devices supported by ISO 13485 certificates remain valid until the certificate expires. Sponsors will then need another form of acceptable manufacturer evidence to support their approved device.
We will publish guidance on the transition to new manufacturer evidence for IVD medical devices soon.
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Regulation of thermometers and other temperature measuring medical devices and products for COVID-19
This guidance assists thermometer sponsors and manufacturers to meet their regulatory obligations
New legislative instrument
Update to GMP approach to overseas manufacturers of medicines and biologicals during the COVID-19 pandemic.
International Council for Harmonisation ICH
ICH E6(R3) draft Guideline reaches Step 2 of the ICH process
The ICH E6(R3) Draft Guideline on “Good Clinical Practice (GCP)” has reached Step 2 of the ICH process on 19 May 2023.
The E6(R3) draft Guideline and guidance for stakeholder public consultation comment collection are available for download on the E6(R3) page.
The guideline is composed of principles and annexes that expand on the principles with specific details for different types of clinical trials.
The guideline applies to interventional clinical trials of investigational products that are intended to be submitted to regulatory authorities and may also be applicable to other interventional clinical trials of investigational products that are not intended to support marketing authorisation applications in accordance with local requirements.
Annex 1 which is included in this Step 2 document is intended to provide information on how the concepts can be appropriately applied to clinical trials.
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Work on Annex 2, regarding additional considerations for interventional clinical trials, has just been initiated, with an Annex 2 Concept Paper approved in May 2023 by the ICH Management Committee.
Guideline E6(R3) Draft Guideline
Guidance for Stakeholder Public Consultation E6(R3) Stakeholder Engagement
Endorsed Documents
Web Conference
The mechanism of not receiving samples in case of non-compliance with any of the mentioned items
The mechanism of submitting cosmetic files for registration in the Evaluation and Accreditation Department
Setting a time limit for companies to complete the new final registration files submitted to the Examination Unit and obtaining approval to proceed with the registration procedures during the previous years until 2015
FDA Updates CDRH Portal to Track Pre-Submissions Progress
May 22, 2023 - The U.S. Food and Drug Administration (FDA) updated the CDRH Portal to allow users to track the progress of Pre-Submissions.
A submitter must specify the type of Pre-Submission request, which include:
•written feedback (only)
•written feedback followed by a meeting
The CDRH Portal updates are a step forward in meeting the Medical Device User Fee Amendments 2022 (MDUFA V) commitments of using technology to enhance efficiency and transparency in reviewing industry submissions.
All CDRH-led premarket submission types may be uploaded to the CDRH Portal at any stage of the review process. Official correspondents do not need to send a physical cover letter to the FDA after uploading an electronic submission to the CDRH Portal. Please note that the CDRH Portal cannot receive submission files larger than 4GB or PDF files with attachments larger than 1GB.
FDA Issues Final Report for Drug Supply Chain Security Act (DSCSA) Pilot Project Program
FDA established the Drug Supply Chain Security Act (DSCSA) Pilot Project Program on February 8, 2019, to help FDA and members of the pharmaceutical distribution supply chain understand the technical capabilities of the supply chain and to assist with identifying system attributes that are necessary to implement the requirements established under the DSCSA to identify and trace certain prescription drugs as they are distributed within the United States.
Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures
This guidance document provides recommendations that may help manufacturers comply with the special controls related to non-clinical performance data for gynecologic and general laparoscopic power morcellation containment systems (“tissue containment systems”).
Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products
This guidance describes FDA’s current recommendations regarding adjusting for covariates in the statistical analysis of randomized clinical trials in drug development programs
Study Data Technical Conformance Guide - Technical Specifications Document
This Study Data Technical Conformance Guide (Guide) provides specifications, recommendations, and general considerations on how to submit standardized study data using FDA-supported data standards located in the FDA Data Standards Catalog (Catalog).
Diabetes Mellitus: Efficacy Endpoints for Clinical Trials Investigating Antidiabetic Drugs and Biological Products; Draft Guidance for Industry; Availability
This guidance is intended to help sponsors develop antidiabetic drugs for adults and children with type 1 diabetes mellitus (T1D) and/or type 2 diabetes mellitus (T2D).
Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers
This guidance provides information to sponsors and nonclinical laboratories regarding the use and management of whole slide images used during histopathology assessment and/or pathology peer review performed for good laboratory practice (GLP)-compliant nonclinical toxicology studies using non-human specimens.
Generally Accepted Scientific Knowledge in Applications for Drug and Biological Products: Nonclinical Information
This guidance describes instances in which it may be appropriate to rely on GASK to meet certain nonclinical safety requirements for new drug applications (NDAs) submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(b)) and biologics license applications (BLAs) under section 351 of the Public Health Service Act (PHS Act) (42 U.S.C. 262(a)).
Heart health is important for all individuals, particularly veterans. Cardiovascular diseases, such as heart failure, heart attacks, strokes, and peripheral artery disease are the leading cause of hospitalization in the Veterans Affairs healthcare system and a major cause of disability impairing the lives of veterans across the United States. Consider participating in the Veterans Cardiac Health and AI Model Predictions (V-CHAMPs) Challenge, intended to encourage the development of artificial intelligence and machine learning (AI/ML) models to predict heart failure related outcomes -- including hospitalization, readmission, and mortality -- using synthetic veteran health records.
This challenge is launched in collaboration with the following agencies, the:
IEC 60601-2-46:2023
Published 26 May 2023
Medical electrical equipment - Part 2-46: Particular requirements for the basic safety and essential performance of operating tablesIEC 60601-2-46:2023 specifies safety requirements for operating tables, whether or not having electrical parts, including transporters, used for the transportation of the operating table top to or from the base or pedestal of an operating table with detachable operating table top.
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Dylan James Brock Marcus Emne Dyuti Trivedi Mona Malhotra Dr. Sathesh Kumar Annamalai Chelsea Patterson Zaryana Davranova Michael Shumilin, MD, MBA Judith Oehler Yvonne Hug Neslihan Oruc David Stadelmann Marianne Stechern Christian Karasch Patrick Kobler Michael Gächter Oliver Haferbeck Mithun Ratnakumar Daniel Diezi Katarzyna N. Maksymowicz, MPharm., MBA Anu Joy Ines Ruestenberg Farid Seddighi Christine Spaenhauer-Horànyi Marie Stockton