In 2023, ISPE International launched an expansive and significant initiative, Enabling Global Pharmaceutical Innovation: Delivering for Patients, to address the barriers to technological innovation in the pharmaceutical industry.

One of the TGA's strategic objectives is to support regulatory innovation; however like many other regulatory agencies the TGA does not have a published position on its approach to regulation of technical innovations; Their view is the current regulation are "technology agnostic" however TGA is currently in the process of a consultation on regulation for the use of AI

The phrase “enabling pharmaceutical innovation” encompasses technical innovations in pharmaceutical manufacturing and analytical technology, the introduction of new medical modalities, modes of delivery and administration of medicines, and digital transformation (Pharma 4.0™).

The phrase “delivering for patients” addresses improved assurance of product quality, supply consistency and reliability, improved product convenience and use, expedited patient access globally, and, where applicable, improved productivity and reduced manufacturing costs

The ISPE initiative includes the following objectives :

1) Contemporize manufacturing technologies, i.e., advanced modeling and simulation, digitalized technologies

2) Reinforce globally harmonized interpretation and implementation of ICH guidelines necessary to advance innovative technology and industry approaches such as Pharma 4.0™, establishing criteria for a globally accepted drug product control strategy

3) Identify sources of regulatory challenges that are barriers or create limitations in applicability across multiple therapeutic modalities

4) Increase the level of clarity and consistency in harmonized approaches and identify and promote incentives for implementation of innovative technology

5) Leverage relevant regulatory harmonization initiatives and convergent regulatory approaches that are in progress regionally, and accelerate the adoption and implementation of ICH guidelines and other harmonization proposals

6) Identify incentives for regulatory authorities to collaborate

7) Assess learnings from the COVID-19 pandemic, where global regulatory and supply distribution experience can serve as a roadmap, i.e., mutual reliance, parallel development, regulator engagement

This presentation will summarize ISPE data coming out of a three part survey concluded in late 2024 which identified a number of current challenges and suggested work streams.

It will also provide an update on regulatory interactions resulting from the communication of the survey findings and case studies used to facilitate discussion.