Regulatory Digest - February 2023

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


ISPE Launches Initiative on Enabling Global Pharma Innovation

ISPE Launches Initiative on Enabling Global Pharma Innovation

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. Read More


Regulatory Panel Discussions: Annex 1 Implementation from the Regulators’ Point of View

The updated EU GMP Annex 1 Revision: Manufacture of Sterile Medicinal Products released in August 2022 introduced changes which require more stringent sterile manufacturing processes, including implementing a contamination control strategy and new technology to reduce the risk of contamination. Regulators discussed those changes and how they impact manufacturing practices during panel discussions at the ISPE Pharma 4.0™ and Annex 1 ConferenceRead More

Regulatory Panel Discussions: Annex 1 Implementation from the Regulators’ Point of View


Bob Tribe, ISPE Asia-Pacific Regulatory Advisor, Retires

Bob Tribe, ISPE Asia-Pacific Regulatory Advisor, Retires

ISPE’s long-time Asia-Pacific Regulatory Advisor Bob Tribe retired from ISPE at the end of 2022, bringing to a close more than 18 years of service to the Society. Read More


ISPE Comments on Draft Guidelines

ISPE provides the opportunity for members to propose comments on select draft regulatory guidelines or guidances. Commenting opportunities are published in the Regulatory and Quality Networking Community.

ISPE recently submitted comments on:


ISPE’s Regulatory Commenting Process

ISPE’s Regulatory Commenting Process

ISPE utilizes its members' expertise and knowledge to provide official comments on government documents.  Although individuals can provide input or comments directly to the authority, the input can have a greater impact when many industry experts pool their comments and submit them as a group through ISPE. Read More