An initiative by FDA and the European Medicines Agency to share duties related to oversight of clinical trials may also reduce the resource burden on sponsors.
A pilot program focusing on human drugs will begin Sept. 1 to determine whether information produced by each other's inspections is sufficient to allow each agency to make its own decisions about compliance with good clinical practices.
Because of dissimilarities in the statutory and regulatory frameworks, it is unlikely the two agencies can adopt the same good clinical practice requirements and format. But FDA notes that by discussing techniques and interpretation of good clinical practices, the two can harmonize procedures where possible.
The good clinical practice initiative, announced Aug. 3, will enable the agencies "to leverage each other's GCP inspectional resources ... to assure more of the clinical trials submitted to both agencies are of the highest quality," Deputy Commissioner for International Programs Murray Lumpkin commented.
The agencies are seeking participants for the pilot program from firms that expect to submit marketing applications to both agencies "fairly simultaneously" within the next 12 months.
The collaboration is another step in the regulatory agencies' efforts to eliminate duplication and maximize use of their review resources to increase oversight of clinical trials and the data they produce.
For industry, the FDA/EMEA collaboration could translate into time and resource savings as well, as the need to host duplicative regulatory visits is minimized.
FDA and EMEA, joined by Australia, previously launched a pilot program to coordinate inspection of active pharmaceutical ingredient facilities in third-country locations (1 PharmAsia News, Jan. 12, 2009).
The response from sponsors participating in that effort has been generally favorable, FDA reports.
FDA and EMEA are cooperating in other areas as well. In 2008 they coordinated their qualification of seven nephrotoxicity biomarkers for preclinical drug testing. While each agency made its own decision, they worked together in reviewing the same scientific submission (2 'The Pink Sheet,' June 2, 2008).
The agencies also have created a common application form for those seeking orphan status for drugs to treat rare diseases. Although some sections are unique to each jurisdiction, information that is needed by both can be filled in once (3 'The Pink Sheet,' June 2, 2008).
Best Practices For Inspections To Be Assessed
The pilot program has an information-sharing and a joint inspection component.
Four to six applications will be involved in the latter segment. Initially, staff from the two agencies will observe how the other assesses sites, and discuss techniques and best practices for conducting inspections.
Each agency then may inspect sites at different geographic locations for the same application. Finally, inspections will be conducted with both regulatory authorities as active participants.
The information-sharing portion of the pilot will involve most, if not all, drugs for which both FDA and EMEA have pending applications.
Sharing good clinical practice information extends to applications for scientific advice, orphan medicines designation, pediatric investigational plans, marketing authorization or post-authorization activities of significant public health interest. Inspection plans will be shared so selection of studies and sites is well-informed, and inspection outcomes will be communicated in a timely fashion.
The agencies also plan to keep each other informed about legislation, guidance and policies that affect how each interprets good clinical practice; and identify areas in which greater convergence could be achieved to improve the clinical research process.
[Editor's note: Keep up with European biopharma business development and policy, at our affiliated site, EuroPharmaToday. Sign up for free email alerts at 4 www.EuroPharmaToday.com)
During fiscal 2008, the Center for Drug Evaluation and Review oversaw 407 clinical investigator site inspections and 43 sponsor/monitor inspections. The pilot program will involve only a small fraction of good clinical practice inspections overseen by CDER.
- Cathy Dombrowski ( 5 c.dombrowski@elsevier.com )
This article also appeared in "The Pink Sheet" – Aug 10, 2009
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