Pharma Stakeholders Call for Global Marketing App, Standardized GCPs

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The FDA should work with other regulatory bodies, especially the European Medicines Agency (EMA), to create a single marketing application that would be accepted by multiple regulators, drug industry insiders urge.

The Biotechnology Industry Organization (BIO) wants the agency to harmonize both the content and structure of drug applications so sponsors can submit the same dossier to several agencies. This would allow drugmakers and regulatory agencies to save resources. The trade group commented in response to the FDA’s request for suggestions to modernize the regulation of clinical trials and approaches to good clinical practice (GCP).

A harmonized application could bring medical products to market sooner, Pfizer U.S. Regulatory Policy Director Carol Haley noted in the company’s comments.

The industry giant suggested the FDA and EMA pilot a project to develop a marketing application acceptable to both agencies and then accept two or three drug applications for dual review each year. The drug regulators would still retain their individual authority to approve or deny an application. Such a pilot would require that the two agencies develop consistent GCP standards, Pfizer said.

With the push for improved compliance and enforcement — and a legion of newly hired and trained investigators — the FDA is coming down hard on sponsors and sites to comply with GCP.

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