As many of our clients know, JLT keeps their clients up to date with legal and regulation changes on a regular basis. The latest 6 monthly update focuses on countries such as Argentina, Australia, Austria, Belgium, Denmark, Germany and Spain. Some of this directly affects insurance whereas other areas directly affect the submission process.
As an example, Argentina continues to take a number of steps to align its regulations with international standards. After implementing new rules on Good Clinical Practice, which set out the regulatory and legal basis for planning, developing and following up on clinical research, on the one part, and a regulation that mainly deals with the functions and activities of ethics committees and the rights, safety and integrity of experimental subjects, on the one part, the regulatory agency ANMAT reinforced the process regarding information and consent within the Clinical Trial Protocol submission.
As an example, Argentina continues to take a number of steps to align its regulations with international standards. After implementing new rules on Good Clinical Practice, which set out the regulatory and legal basis for planning, developing and following up on clinical research, on the one part, and a regulation that mainly deals with the functions and activities of ethics committees and the rights, safety and integrity of experimental subjects, on the one part, the regulatory agency ANMAT reinforced the process regarding information and consent within the Clinical Trial Protocol submission.
Continue reading JLT keeps industry abreast of legal changes affecting clinical trials.
