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.

ISPE Regulatory Digest Q3 2024

Regulatory

ISPE is committed to fostering communications and interactions to advance common interests among the pharmaceutical industry and regulatory agencies. FDA on AI in Pharmaceutical Manufacturing At ISPE’s 2024 Biotechnology...

ISPE Regulatory Digest Q2 2024

Regulatory

ISPE is committed to fostering communications and interactions to advance common interests among the pharmaceutical industry and regulatory agencies. ISPE Issues Report on Barriers to Innovation Industry reports...

ISPE Regulatory Digest Q3 2023

Regulatory

ISPE is committed to fostering communications and interactions to advance common interests among the pharmaceutical industry and regulatory agencies. Regulators on Trust, Collaboration, Reliance, Harmonization...

ISPE Regulatory Digest Q2 2023

Regulatory

ISPE is committed to fostering communications and interactions to advance common interests among the pharmaceutical industry and regulatory agencies. Barriers to Innovation: Your Input Requested ISPE has launched a...

ISPE Launches Initiative on Enabling Global Pharma Innovation

Regulatory Digest - February 2023

Regulatory

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 Enabling...

ISPE Highlights Pharma 4.0 at PIC/S 50th Anniversary Event

Regulatory Digest Q1 2023

Regulatory

ISPE is committed to fostering communications and interactions to advance common interests among the pharmaceutical industry and regulatory agencies. ISPE’s Advancing Pharmaceutical Quality (APQ) Program Fully Launched...

ATMP Regulations: Comparison of EudraLex Part IV with PIC/S Annex 2A

Regulatory Digest Q3 2022

Regulatory

ISPE is committed to fostering communications and interactions to advance common interests among the pharmaceutical industry and regulatory agencies. Are you ready to implement ICH Q9(R1)? That question was at the heart...

Regulator/Industry Panels at ISPE European Annual Conference

Regulatory Digest Q2 2022

Regulatory

ISPE is committed to fostering communications and interactions to advance common interests among the pharmaceutical industry and regulatory agencies. Regulator/Industry Panels at ISPE European Annual Conference A panel...

Industry Study Finds Divergence in Regulators’ Interpretation of ICH Guidance Related to Control Strategies

Regulatory Digest Q1 2022

Regulatory

ISPE is committed to fostering communications and interactions to advance common interests among the pharmaceutical industry and regulatory agencies. Industry Study Finds Divergence in Regulators’ Interpretation of ICH...

Regulators Discuss Contemporary Approaches to Drug Shortage Prevention

Regulatory Digest Q4 2021

Regulatory

ISPE is committed to fostering communications and interactions to advance common interests among the pharmaceutical industry and regulatory agencies. US FDA and WHO Highlight Agility and Collaboration at ISPE Annual...