Regulatory Affairs Banner


Regulators join ISPE to gain the most effective means for engaging industry in discussion about the various ways industry interprets GMPs, regulations, risk management, and quality systems.

  • ISPE provides YOU…

    forums in which you can interact directly with regulators on the issues that are of greatest concern to you and your company.
  • ISPE is the LEADING…

    technical organization to which regulators turn to organize and facilitate dialog with industry.

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.

Current Regulatory Initiatives and Groups

Drug Shortages

ISPE’s Drug Shortage Initiative is facilitating communication between the pharmaceutical industry and global health authorities to understand and address this complex problem.

Learn more

Quality Metrics

ISPE is conducting the industry’s first Quality Metrics Pilot Program designed to define and operationalize standard metrics reporting to the FDA. The pilot will refine the proposed set of metrics and definitions, data submission process, and evaluation.

Learn more

Blend Uniformity/Content Uniformity

An ISPE-sponsored group of regulators, industry, and academia are identifying alternative approaches to assess Blend and Content Uniformity.

Learn more

Regulatory and Compliance Committee (RCC)

The RCC’s role is to build effective partnerships with regulators and agencies globally and ensure all ISPE Members have access to the latest regulatory developments and expectations.

RCC Regional Focus Groups facilitate global activity:

  • Asia-Pacific Focus Group
  • Europe-Middle East-Africa Focus Group
  • Latin America Focus Group
  • North America Focus Group

Product Quality Lifecycle Implementation (PQLI®)

Through PQLI, ISPE assists industry and regulators in advancing manufacturing sciences across the product lifecycle in order to achieve excellence in drug development and in pharmaceutical production. Manufacturing sciences shall be defined as the integrated application of scientific knowledge, technical innovation and quality risk management to deliver product and process understanding.

PQLI Technical Committees address various key topics:

  • Process Validation
  • Process Capability
  • Knowledge Management

Learn more

Regulatory Comments

As an ISPE Member, you can participate in the creation of science-based regulations and guidelines.

As regulatory agencies invite public comment on a new or revised regulation or guidance, they look to ISPE for input on the latest scientific and technical developments. 

Print this page