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FDA Staff Guidance for Industry and FDA Staff

This guidance represents the current thinking of the US 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 meets the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA Office responsible for this guidance.


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 medical device diagnostics (WHO Medical device technical series)

This document was adopted by the WHO Expert Committee on 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


Guidelines for ANSM inspection suites

The ANSM has inspection powers, an important pillar of its mission to monitor the activity of operators contributing to the placing on the national or European market of the health products listed in Article L. 5311-1 of the Code of public health (CSP).


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

European Commission
Direcorate-General for Health and Food Safety

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


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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Commit to share
Transmit and progress together
Promoting innovation

The A3P Association is a major player in the pharmaceutical and biotechnology industry.
Created in 1986, it contributes to the good development of the production of medicines and clean and sterile equipment, it runs a network of professionals 21 000, manufacturers and suppliers, as part of International Congress and technical days.

It now has over 1700 members who share their technical experience, scientific and regulatory.

More info on video (Versiongb - drapeauitalie )

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BROWSER A3P is a tool comprising the majority of links to texts, guides, regulatory documents and websites for the pharmaceutical, biotechnology and biomedical.
  • GMP & Guides

  • Country Sites

  • Regulatory Sites

  • Pharma areas

  • other Sites

   version 1.00                                                                                                               youtube channel   linkedin