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Classification of Products as Drugs and Devices & Additional Product Classification Issues: Guidance for Industry and FDA Staff

This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the title page of this guidance.

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WHO Global Model Regulatory Framework for Medical Devices including in vitro diagnostic medical devices

WHO global model regulatory framework for medical devices including in vitro diagnostic medical devices (WHO Medical device technical series)

This document was adopted by the WHO Expert Committee on Specifications for Pharmaceutical Preparations at its 51st meeting, which took place in Geneva from 17 to 21 October 2016, and will be published as Annex 4 to its report: Fifty-first report of the WHO Expert Committee on specifications for pharmaceutical preparations

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Lignes directrices relatives aux suites d'inspection ANSM

L'ANSM dispose de prérogatives d'inspection, pilier important de sa mission de surveillance de l'activité des opérateurs contribuant à la mise sur le marché national ou européen des produits de dsanté listés à l'article L. 5311-1 du code de la santé publique (CSP). 

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Safety Features for Medicinal Products for Human use - Questions & Answers Version 8

European Commission
Direcorate-General for Health and food safety

Health systems and products
Medical products – quality, safety and innovation

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Deciding When to Submit a 510(k) for a Software Change to an Existing Device

Deciding When to Submit a 510(k) for a Software Change to an Existing Device
Guidance for Industry and Food and Drug Administration Staff

Document issued on October 25, 2017.
The draft of this document was issued on August 8, 2016.

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L’Association A3P est un acteur incontournable de l’industrie pharmaceutique et biotechnologique. 
Créée en 1986, elle contribue au bon développement de la production de médicaments et de matériels propres et stériles, elle anime un réseau de 21 000 professionnels, fabricants et fournisseurs, dans le cadre de Congrès internationaux et de journées techniques.

Elle regroupe aujourd’hui plus de 1700 adhérents qui partagent leurs expériences techniques, scientifiques et réglementaires.

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NAVIGATEUR A3P est un outil regroupant la majorité des liens vers les textes, guides, documents et sites réglementaires pour les industries pharmaceutiques, biotechnologies et biomédicales.
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