Research & DevelopmentRegulatory Harmonization

In the biopharmaceutical industry, regulatory harmonization is the process by which technical guidelines are developed to be uniform across participating authorities. Greater regulatory harmonization and transparency will promote job growth, innovation and better health and welfare for the citizens of our countries.

Good clinical practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. Compliance with this standard, as defined by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), provides public assurance that the rights, safety, and wellbeing of trial subjects are protected. 

PhRMA members have had a longstanding commitment to sponsoring clinical research that fully complies with all legal and regulatory requirements. Many different entities and individuals contribute to the safe and appropriate conduct of clinical research, including not only sponsoring companies but also regulatory agencies; investigative site staff and medical professionals who serve as clinical investigators; hospitals and other institutions where research is conducted; and Institutional Review Boards and Ethics Committees.

The Food and Drug Administration (FDA), along with these international standards, govern the safe and ethical conduct of clinical trials. Additionally, our member companies agree to PhRMA’s Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results. PhRMA adopts these voluntary principles to fortify our members' commitment to ethics and responsible sharing of clinical trial information. Today, the clinical trial process is the safest and most productive it has been in history.