Medical and Regulatory Affairs

ICH GCP E6 (R2): A Primer for Small Biotech and Specialty Pharma Companies

Recent updates to the ICH Good Clinical Practice guidelines call for implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording, and reporting that are intended to increase clinical trial quality and efficiency while continuing to ensure human subject protection and data integrity.

Now, biotech and specialty pharma innovators face even greater sponsor responsibilities, the most significant of which may be design and development of Clinical Quality Management Systems to achieve compliance with the revised guidelines.

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline for Good Clinical Practice (GCP) was first produced in June 1996 as an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects.2 While the original ICH GCP still provides an excellent standard for the conduct of clinical trials in humans, the research environment has changed since those guidelines came into effect.

In 2016, ICH GCP – which remained unchanged for 20 years – was updated by means of an addendum, which provides additional guidance without changing the existing text. In this white paper, we will explore the revised guideline and discuss its impact on small biotech and specialty pharma sponsors, with a focus on risk-based approaches to quality management.


Since the introduction of ICH GCP in 1996, the clinical trial landscape has fundamentally changed. Advances in technology – the proliferation of the internet, smartphones, electronic data capture, real-time review of clinical data – have created new opportunities and transformed the drug development process into a truly global enterprise.

Technological progress is, however, counterbalanced by the growing complexity and cost of clinical trials, as well as the increased rigor of ethical and quality standards. Conduct of global clinical trials requires progressively greater division of tasks across multiple functional teams, organizations, and locations. Thus, the current research environment is creating pressure on sponsors, particularly resource-constrained small biotech and specialty pharma companies.

To read more, download the complete white paper by submitting the white paper on this page.