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Regulatory Update, January 2016

Friday, January 1, 2016

FDA Seeks Comments on ICH’s GCP Guideline Update

In Sept. 29’s Federal Register, the FDA announced the availability of a draft guidance titled “Guideline for Good Clinical Practice” E6 (R2). The draft is an update of the International Conference on Harmonisation’s (ICH) “Guideline for Good Clinical Practice” E6 (R1), in which new information is integrated into the original document. The changes are intended to encourage improved and more efficient approaches to clinical trial design, conduct, oversight, recording, and reporting, and also to update standards regarding electronic records and essential documents. The draft also is intended to improve clinical trial quality and efficiency while maintaining human subject protection. The FDA made the draft guidance available for public comment on the sections added to ICH E6 (R1) and marked as “ADDENDUM.”

Regulatory authorities and industry associations have collaborated for years to promote international harmonization of regulatory requirements for pharmaceutical development and marketing. A major goal of harmonization is to identify and reduce differences in registration (marketing) requirements for drug development among different countries. ICH was organized to provide for tripartite harmonization initiatives among three regions: the European Union, Japan and the United States. Currently, ICH has eight sponsors: the European Commission; the European Federation of Pharmaceutical Industries Associations; the Japanese Ministry of Health, Labor, and Welfare; the Japanese Pharmaceutical Manufacturers Association; the FDA (with participation by its drug and biological product regulatory centers); the Pharmaceutical Research and Manufacturers of America; Health Canada; and Swissmedic.

Last June, ICH’s Steering Committee agreed to make the draft document available for public comment. When the document is made final, FDA will issue it as a final guidance document, as it did on May 9, 1997, with the original ICH GCP Guideline. Evolutions in technology and risk management processes offer new opportunities to increase clinical trial efficiency, in part by focusing on trial activities essential to ensuring human subject protection and the reliability of trial results. For example, the draft guidance recommends sponsors implement a system to manage quality throughout clinical trials and recommends sponsors develop a systematic, priority-based, risk-based approach to monitoring clinical trials. The draft guidance provides additional detail regarding recommendations for use of electronic trial data handling and remote electronic trial data systems.

FDA decided to end the comment period on Nov. 30 of last year. The European and Canadian authorities are allowing comments through Jan. 31. Therefore, sending in late comments (after Nov. 30) should still be considered by interested parties. Send written or electronic comments on the draft as instructed above and identify them with Docket No. FDA-2015-D-3327.

FDA Draft Guidance on Microbial Vectors Used for Gene Therapy

In Oct. 14’s Federal Register, the FDA announced the availability of a draft guidance titled “Recommendations for Microbial Vectors Used for Gene Therapy; Draft Guidance for Industry.” The draft provides investigational new drug application (IND) sponsors with recommendations concerning IND submissions for microbial vectors used for gene therapy (MVGTs) in early-phase clinical trials. MVGTs meet the regulatory definition of “biological product” when such products are applicable to the prevention, treatment, or cure of a disease or condition of human beings. The draft focuses on the chemistry, manufacturing, and control (CMC) information that sponsors should submit in an IND for MVGTs and provides an overview of preclinical and clinical considerations for these products. When made final, the document will supplement a guidance titled “Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)” dated April 2008.

MVGTs include bacterial vectors such as Salmonella, Listeria or E. coli, genetically modified to express human tumor antigens, cytokines, growth factors, enzymes, therapeutic proteins, or nucleotides. MVGTs also may be generated by the modification (deletion, truncation, or point mutation) of chromosomal or episomal genes and by the insertion of foreign genetic material into the chromosome, or into naturally occurring episomes; or by the introduction of one or more plasmids. MVGTs may be microbes that are either live, replication-restricted (divided under specific growth conditions), capable of limited or no cell divisions, or killed, or a combination of those forms. In the April 2008 guidance, the FDA provided sponsors of a human gene therapy IND, including those with combination products that contain a human gene therapy biological product with a drug or device as part of the final product, with recommendations on CMC information that is to be included in an original IND. That guidance also provided instruction to the FDA’s CMC reviewers about the information to record and assess as part of an IND review.

Because last month’s due date of Dec. 14 passed before this issue of The CenterWatch Monthly was released, instructions on commenting are not provided here. Comments submitted by others were identified with Docket No. FDA-2015-D-3399. 

The Regulatory Update is excerpted from Research Practitioner, Volume 16, Number 6, November-December 2015. 

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