Concepedia

Product Registration

Product Registration is a regulatory process by which a pharmaceutical, biologic, or medical device product is formally submitted to and evaluated by a national or regional regulatory authority to obtain legal market authorization based on demonstrated quality, safety, and efficacy.

262

Publications

11.8K

Citations

939

Authors

429

Institutions

Publications per year

2017–2026

76

Variants

Marketing Authorization

Parents

Children

Publications

262

International conference on harmonization of technical requirements for registration of pharmaceuticals for human use

Jatinder Singh · Journal of Pharmacology and Pharmacotherapeutics · 2015 · 897 citations

, , +14

International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use (ICH).

Nigel S. Baber · British Journal of Clinical Pharmacology · 1994 · 767 citations · Full text

, , +11

GlobCover - Products Description and Validation Report

P. Bicheron, Defourny Pierre, Carsten Brockmann et al. · Joint Research Centre (European Commission) · 2008 · 649 citations

, , +10

MSC-Based Product Characterization for Clinical Trials: An FDA Perspective

Michael Mendicino, Alexander M. Bailey, Keith Wonnacott et al. · Cell stem cell · 2014 · 490 citations · Full text

, , +9

INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE

Ich Harmonised, Tripartite Guideline · 2006 · 434 citations

, , +8

1–5 of 262

Authors

939

  1. RW
    R. W. Mozingo

    North Carolina State University, United States

    4 publications · 116 citations

    4

    h-index

  2. AS
    Aaron S. Kesselheim

    Brigham and Women's Hospital, United States

    4 publications · 112 citations

    4

    h-index

  3. RF
    Reed F. Beall

    University of Calgary, Canada

    4 publications · 233 citations

    4

    h-index

  4. SS
    Sam Salek

    University of Hertfordshire, United Kingdom

    4 publications · 59 citations

    4

    h-index

  5. TS
    Tariro Sithole

    University of Hertfordshire, United Kingdom

    3 publications · 85 citations

    3

    h-index

1–5 of 939

Institutions

429

  1. United States Food and Drug Administration

    Silver Spring, United States

    8 h-index

    18 publications

    444 citations

  2. Utrecht University

    Utrecht, The Netherlands

    6 h-index

    11 publications

    309 citations

  3. World Health Organization

    Geneva, Switzerland

    6 h-index

    10 publications

    298 citations

  4. European Medicines Agency

    Amsterdam, Netherlands

    5 h-index

    19 publications

    619 citations

  5. Centre for Innovation in Regulatory Science

    London, United Kingdom

    4 h-index

    4 publications

    99 citations

  6. Pharmo Institute

    Utrecht, Netherlands

    4 h-index

    4 publications

    129 citations

  7. University of Hertfordshire

    Hatfield, United Kingdom

    4 h-index

    11 publications

    159 citations

  8. Newcastle University

    Newcastle upon Tyne, United Kingdom

    4 h-index

    11 publications

    280 citations

1–8 of 429

Venues

  1. Crop Science

    18 publications · 383 citations

    13

    h-index

  2. PubMed

    Repository · 15 publications · 502 citations

    13

    h-index

  3. Nature Biotechnology

    4 publications · 68 citations

    4

    h-index

  4. Frontiers in Medicine

    4 publications · 82 citations

    4

    h-index

  5. Orphanet Journal of Rare Diseases

    OJRD · 4 publications · 188 citations

    4

    h-index

1–5