Regulations Impacting the Pharma Industry

1990, April – ICH was first formed during a meeting, held by the EFPIA in Brussels, in 1990. Representatives of the regulatory agencies and industry associations of Europe, Japan, and the United States met, primarily, to plan an International Conference.

1991– The adoption of final version of " common rule" governing protection of human subjects for research sponsored by all federal agencies

1992 – PDUFA, the first FDA user fee program.

1993 – Second ICH Conference in Orlando.

1996 – Third ICH Conference in Yokohama.

1996 – Congress enacts HIPAA (Health Insurance Portabiality & Accountability Act) with provisions regarding privacy of human medical records.

1996-ICH GCP Guideline finalized

1997– FDAMA-pediatric studies & incentives (expanded under 2003 Pediatric Research Equity Act); clinicaltrials.gov, fast track approvals