ISPE is committed to fostering communications and interactions to advance common interests among the pharmaceutical industry and regulatory agencies.
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
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 Conference. Read More
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:
- FDA Distributed Manufacturing and Point-of-Care Manufacturing of Drugs Discussion Paper
- EMA Concept Paper on the revision of Annex 11 of the guidelines on Good Manufacturing Practice for medicinal products – Computerised Systems
- See all past comments
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