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Regulatory Update, January 2017

Sunday, January 1, 2017

FDA Publishes Several Draft Guidance Documents

The FDA published several draft guidance documents. Although the dates for submit­ting comments will have passed before this is­sue is distributed, interested parties should still consider submitting comments on these draft documents with the indicated Docket Number included in the comments.

ICH E17 General Principles for Planning and Design of Multi-Regional Clinical Trials

In the September 9, 2016, Federal Register, the FDA announced the availability of a draft guidance for the industry titled “E17 General Principles for Planning and Design of Multi- Regional Clinical Trials.” The draft guidance was prepared under the auspices of the Inter­national Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The draft guidance describes general principles for planning and designing multi-regional clinical trials (MRCT). MRCT conducted according to the guidance will in­vestigate treatment effects in overall popula­tions with multiple ethnic factors (intrinsic and extrinsic factors as described in the ICH guid­ance titled “E5 Ethnic Factors in the Accept­ability of Foreign Clinical Data”) and evalu­ate the consistency of treatment effects across populations. The draft guidance is intended to increase the acceptability of data from MRCT as the primary source of evidence supporting marketing approval in global regulatory sub­missions and to thereby facilitate more efficient drug development and earlier access to medi­cines. One of the goals of harmonization is to identify and then reduce differences in techni­cal requirements for drug development among regulatory agencies. The ICH was organized to provide an opportunity for harmonization ini­tiatives to be developed with input from both regulatory and industry representatives.

The draft guidance provides guidance on general principles for planning and designing MRCT. Drug development has been global­ized, and MRCT for regulatory submission have widely been conducted in the ICH regions and beyond. Regulatory agencies are currently facing some challenges in evaluating data from MRCT for drug approval, and the ICH is devel­oping this harmonized international guidance to promote the appropriate conduct of MRCT and to focus especially on scientific issues in planning and designing MRCT. This new guidance will complement the E5 guidance on MRCT and facilitate MRCT data acceptance by multiple regulatory agencies. Interested parties may submit electronic or written com­ments as instructed above. Identify comments with Docket No. FDA-2016-D-2567.

Software as a Medical Device: Clinical Evaluation

In the October 14, 2016, Federal Register, the FDA announced the availability of a draft guidance titled “Software as a Medical Device (SaMD): Clinical Evaluation.” The draft guid­ance was prepared under the auspices of the International Medical Device Regulators Fo­rum (IMDRF), formerly the Global Harmoni­zation Task Force. The draft guidance pertains to the conduct of clinical evaluation of SaMD and focuses on the general principles of clinical evaluation, which includes establishing the sci­entific validity, clinical performance and ana­lytical validity for a SaMD. The draft guidance is intended to provide globally harmonized principles of when and what type of clinical evaluation is appropriate based on the risk of the SaMD.

IMDRF seeks to advance international har­monization or convergence of medical device regulation. It was organized to provide an op­portunity for global harmonization initiatives to be developed with input from both regula­tory and industry representatives. In Septem­ber 2016, the IMDRF Management Committee endorsed the draft guidance titled “Software as a Medical Device (SaMD): Clinical Evaluation” and agreed that the guidance should be made available for public comment. Comments about this draft will be considered by the FDA and the IMDRF SaMD WG. The FDA welcomes comments on all aspects of the draft guidance as well as eight particular issues of interest that are detailed in this notice. The draft guidance and the IMDRF comment page are available at http://www.imdrf.org/consulta-tions/consultations.asp#current. Identify comments with Docket No. FDA-2016-D-2483.

NIH Rule on Clinical Trials Registration and Results Information Submission

On September 21, 2016, the NIH of the federal Department of Health and Human Services (DHHS) issued this final rule (regulation/s). It details the requirements for submitting registration and summary results information, including adverse event information, for specified clinical trials to ClinicalTrials.gov, the clinical trial registry and results data bank operated by the NIH’s National Library of Medicine (NLM). This rule provides for the expanded registry and results data bank specified in the FDA Amendments Act of 2007 (FDAAA) to help patients find trials for which they might be eligible, enhance the design of clinical trials and prevent duplication of unsuccessful or unsafe trials, improve the evidence base that informs clinical care, increase the efficiency of drug and device development processes, improve clinical research practice and build public trust in clinical research. The requirements apply to the responsible party for certain clinical trials of drug products and medical device products that are regulated by the FDA and for pediatric post-market surveillance of a medical device product that is ordered by the FDA. The final rule clarifies and expands requirements for the submission of clinical trial registration and results information to the ClinicalTrials.gov database. It implements provisions of the Public Health Service Act as amended by the FDAAA, which was in­tended to improve public access to information about certain clinical trials of FDA-regulated products. Those responsible for specified clini­cal trials of these FDA-regulated products have been required to submit registration informa­tion to ClinicalTrials.gov since December 26, 2007, summary results information for clinical trials of approved products as of September 27, 2008, and certain adverse events information since September 27, 2009.

This final rule does not impose require­ments on the design or conduct of clinical tri­als or on the data that must be collected dur­ing clinical trials. Instead it specifies how data that were collected and analyzed in accordance with a clinical trial’s protocol are submitted to ClinicalTrials.gov. No patient-specific data are required to be submitted by this rule or by the law this rule is intended to implement. There were 901 comments received on the proposed rule after it was issued, which are presented as summaries in this notice. These regulations are effective on January 18, 2017.

NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information

On September 21, 2016, the NIH issued this policy to promote broad and responsible dis­semination of information from NIH-funded clinical trials through ClinicalTrials.gov. The policy establishes the expectation that all in­vestigators conducting clinical trials funded in whole or in part by the NIH will ensure that these trials are registered at ClinicalTrials.gov, and that trial results information is submitted to ClinicalTrials.gov. The policy is complemen­tary to regulatory reporting requirements in 42 CFR 11.

This policy was first released as a draft on November 19, 2014. There were about 240 pub­lic comments on the draft policy from stake­holders such as researchers, academic/ research institutions, medical practitioners, patients, patient/disease advocacy groups, scientific/pro­fessional societies, device manufacturers, trade associations, not-for-profit non-governmental organizations, and the general public. Interest­ed readers are directed at the Overview of Pub­lic Comments (and a summary of responses from the NIH to those comments), provided in this notice. This policy will take effect January 18, 2017.


The Regulatory Update is excerpted from Research Practitioner, Volume 17, Number 6, November/December 2016.

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