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 - February 2023
Enabling Global Pharmaceutical Innovation: Delivering for Patients aims to catalyse consistent, harmonized interpretation and implementation of ICH guidelines by focusing on challenges to the technical innovations that can increase quality assurance and expedite patient access to medicines globally.
Regulatory Digest - December 2022
The APQ Program is a quality management maturity assessment built by industry experts for use by industry that provides a practical set of tools and systematic approaches for organizations to advance the effectiveness of their PQS.
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Regulatory Digest - August 2022
That question was at the heart of ISPE’s recent Expert Xchange: Regulatory Summit on ICH Q9 Revision. Participants had an unparalleled opportunity to hear from several members of the ICHQ9 (R1) Expert Working Group how many of the public comments made on the guide were being addressed and discuss implementation of the revision’s key focus areas.
Regulatory Digest - June 2022
A panel discussion held on 26 April focused on the linkages among Sustainability, Annex 1 revision implementation, and Good Engineering Practice with panellists from AEMPS, AGES, ANSM, EMA, FDA and WHO as well as EFPIA. Regulators were asked about future regulation of sustainability and how it may be impacted by the revised Annex 1, and more.
Regulatory Digest - 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.
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.
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
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 Digest - 03 March 2021
ISPE is committed to fostering communications and interactions to advance common interests among the pharmaceutical industry and regulatory agencies.
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.