Regulatory Digest - Regulatory Newsletter

This quarterly newsletter is dedicated to news about ISPE’s regulatory and quality activities. ISPE is committed to fostering communications and interactions to advance common interests among the pharmaceutical industry and regulatory agencies. ISPE provides a neutral environment where our individual Members and experts belonging to Health Authorities can engage in open dialogue on issues that will ultimately benefit patients around the world.


The Regulatory Digest Newsletter

Regulatory Digest - 24 February 2022

Regulatory Digest - 24 February 2022

A recent article published by ISPE shares data that highlights instances where divergence in the interpretation of ICH guidelines by regulators in different regions had led to multiple control strategy variants, presenting challenges to marketing a single product in global markets.

US FDA and WHO Highlight Agility and Collaboration at ISPE Annual Meeting & Expo

Regulatory Digest - 1 Dec 2021

Presentations by Elizabeth Miller, Assistant Commissioner for Medical Products and Tobacco Operations, FDA/ORA; and Deus Mubangizi, Unit Head, WHO Regulation & Prequalification Department, spotlighted the unprecedented levels of agility, innovation, and collaboration that permitted the continuation of mission-critical activities while new drugs and vaccines were approved.

Global Regulators and Industry discuss Shared Responsibility for QRM at ISPE June Summit

Regulatory Digest - 15 Sept 2021

ISPE’s second virtual Global Pharmaceutical Regulatory Summit, held on 16 June 2021, brought regulators from the EMA, MHRA, TGA, Philippines FDA and the US FDA together with industry professionals to discuss shared responsibility for application of quality risk management across key stakeholders, and what regulators and industry can do to achieve it.

Regulatory Digest - 26 May 2021

Regulatory Digest - 26 May 2021

Approaches to inspecting and assessing pharmaceutical manufacturing facilities have been a critical point of discussion as industry and regulators navigate the current pandemic environment.

Regulatory Connect

Regulatory Digest - 03 March 2021

ISPE is committed to fostering communications and interactions to advance common interests among the pharmaceutical industry and regulatory agencies.

Regulatory Connect

Regulatory Digest - 30 September 2020

Introducing ISPE’s Regulatory Connect - This new quarterly newsletter is dedicated to news about ISPE’s regulatory and quality activities. ISPE is committed to fostering communications and interactions to advance common interests among the pharmaceutical industry and regulatory agencies.


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For more information, contact Carol Winfield, ISPE Sr. Director Regulatory Operations