Regulatory Initiatives

Leadership in regulation and quality affairs associated with ISPE core concerns and priorities

ISPE strives to facilitate industry wide clarity of new applicable regulations, advising on impacts and resolving towards solutions, seeking harmonization of regulatory expectations where desired and possible.

ISPE engages with all levels of regulators in the development and presentation of our education, training, document development, and interpretation to ensure that our offerings are cutting-edge and focused on clarifying issues and solving problems of importance to industry.

Multi-Faceted Project Teams

ISPE’s Multi-Faceted Project Teams are working groups addressing broad umbrella topics in the regulatory area on the following topics:


Product Quality Lifecycle Implementation® (PQLI)

PQLI is ISPE’s initiative for a practical approach to implementation of International Conference on Harmonization (ICH) guidances Q8 (R2), Pharmaceutical Development; Q9, Quality Risk Management; Q10, Pharmaceutical Quality System; and Q11, Development and Manufacture of Drug Substances. Learn more about PQLI

Product Quality Lifecycle Implementation® Technical Teams

PQLI Technical Teams are working groups addressing broad cutting edge regulatory and compliance issues that affect industry across dosage forms and in small and large molecules.


Regulatory Quality Harmonization Committee (RQHC)

The Regulatory Quality Harmonization Committee builds effective partnerships with regulators and agencies globally and ensures ISPE Members have access to the latest regulatory developments and expectations. The work of the Regulatory Quality Harmonization Committee is carried out by its four Regional Focus Groups in Asia-Pacific, Europe-Middle East-Africa (EMEA), Latin America, and North America.  Learn more about Regulatory Quality Harmonization Committee.


Additional Initiatives


Review and Comment on Regulatory Guidance:  Pharmaceutical professionals at all stages of their careers turn to ISPE for the latest regulatory information. Help shape your industry by providing input into ISPE’s official industry response to draft guidance from regulatory agencies around the world. Learn more

For more information, contact RegulatoryAffairs@ispe.org