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Nov 17, 2020

Consideration on Core Requirements for Risk Management Plans of COVID-19 Vaccines —CoreRMP19 Guidance
On 13 November 2020 the EMA issued the new guidance on risk management plans (RMPs) for COVID-19 vaccines.

The guidance reflects special safety monitoring measures for COVID-19 vaccines by providing considerations and requirements for several sections of the RMP.

EMA will publish the full body of the RMP (plus Annex 4) for all authorized COVID-19 vaccines, in line with its exceptional transparency measures for COVID-19 medicines.

This coreRMP19 document addresses the planning for post-marketing surveillance for COVID-19 vaccines in the context of marketing authorization in the EU.

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Certificates of Confidentiality
On 13 November 2020 the FDA issued the final guidance for sponsors, sponsor-investigators, researchers, industry, and FDA staff.

This guidance describes FDA implementation of the revised provisions applicable to the request for, and issuance of, a Certificate of Confidentiality (CoC). The 21st Century Cures Act (Cures Act) (Public Law 114-255) amended the Public Health Service Act (PHS Act), section 301(d) (42 U.S.C. 241(d)) relating to the issuance of CoCs. A CoC is intended to help protect the privacy of human subject research participants from whom identifiable, sensitive information is being collected or used in furtherance of the research. Historically, a CoC generally protected a researcher from being compelled to disclose identifiable, sensitive information about the research participant, created or compiled for purposes of the human subject research. As amended, the statute broadened the protections by affirmatively prohibiting holders of CoCs from disclosing such information unless a specific exception applies.

The Cures Act simplified certain aspects of the issuance of CoCs by requiring that CoCs be issued for federally-funded human subject research that collects or uses identifiable, sensitive information (referred to in this guidance as mandatory CoCs). For non-federally funded research, issuance of CoCs is not required but may be issued at the discretion of FDA (referred to in this guidance as discretionary CoCs). FDA intends to continue receiving and considering such requests and will issue discretionary CoCs as appropriate. This guidance is intended to provide information on how to request a discretionary CoC, the statutory requirements for requesting such a CoC, and the statutory responsibilities associated with possessing a CoC. Although the mandatory CoC and the discretionary CoC are issued under different processes, the protections afforded by the issuance of either CoC are identical and the statutory responsibilities are the same.

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Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs
On 13 November 2020 the FDA issued the final guidance for industry.

Over the past few decades, FDA has promoted enrollment practices that would lead to clinical trials that better reflect the population most likely to use the drug if the drug is approved, primarily through broadening eligibility criteria. Despite these efforts, challenges to participation in clinical trials remain, and certain groups continue to be underrepresented in many clinical trials. This guidance recommends approaches that sponsors of clinical trials intended to support a new drug application or a biologics license application can take to increase enrollment of underrepresented populations in their clinical trials.

This guidance considers both demographic characteristics of study populations (e.g., sex, race, ethnicity, age, location of residency) and non-demographic characteristics of populations (e.g., patients with organ dysfunction, comorbid conditions, disabilities, those at the extremes of the weight range, and populations with diseases or conditions with low prevalence). Enrolling participants with a wide range of baseline characteristics may create a study population that more accurately reflects the patients likely to take the drug if it is approved and allow assessment of the impact of those characteristics on the safety and effectiveness of the study drug.

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Information on the Member States Requirement for the Nomination of a Pharmacovigilance (PhV) Contact Person at National Level
On 11 November 2020 the EMA PhV Inspectors Working Group (IWG) updated the information on PhV contact person.

PhV IWG is involved in the preparation of new and revised guidance and EU procedures relating to PhV inspections. Based on PhV IWG survey, the new PhV information has been updated on the EU member states requirement for the nomination of a PhV contact person at national level.

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Guidance on Minimizing Disruptions to the Conduct and Integrity of Clinical Trials of Medicines During COVID-19
On 11 November 2020 the UK MHRA issued the guidance.

This guidance follows on from that published on managing clinical trials during coronavirus (COVID-19) and has been developed to assist those involved in running clinical trials of medicines. This will avoid disruptions as a result of the continuing pandemic and will support appropriate incorporation of the available flexibilities into normal practice for the benefit of trial participants. It is relevant to those involved with ongoing studies, those wishing to restart trials that have been paused or temporarily halted, and those wishing to start new studies.

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Detailed Guide Regarding the EudraVigilance Data Management Activities by the EMA
On 9 November 2020 the EMA announced the availability of the updated guide.

This document provides an overview of the data management and quality assurance activities performed by the EMA on information of suspected adverse reactions and medicinal products reported to and held in EudraVigilance and the XEVMPD.

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Regulatory Considerations for Microneedling Products
On 9 November 2020 the FDA issued the final guidance for industry and FDA staff.

This guidance is being issued to assist industry in understanding when a microneedling product is a device as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 321(h), and is, therefore, subject to the device requirements under the FD&C Act and its implementing regulations. This document also provides information on the regulatory pathway to market for microneedling devices for aesthetic use.

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Drug Trial Snapshots Summary Report – from 2015 to 2019
On 9 November 2020 the FDA announced the availability of a five-year summary and analysis of clinical trials participation and demographics.

Beginning in 2015, and in response to the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA 907), the FDA’s Center for Drug Evaluation and Research (CDER) has been reporting clinical trial demographic data for new molecular entities and original biologics through the Drug Trials Snapshots (DTS) program. Individual drug trial snapshots and annual summaries have been provided on the FDA website for the past five years. This summary report aggregated demographic data from DTS snapshots published between 2015 and 2019.

According to the Center for Drug Evaluation and Research (CDER) Drug Trials Snapshots (DTS) Summary Report 2015–2019, the U.S. accounted for 35%, or 102,468 out of a total of 272,766 participants, followed by Poland, Germany and Russia with 4% each and Japan, Canada and the Czech Republic at 3%.

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Process to Request a Review of FDA's Decision Not to Issue Certain Export Certificates for Devices
On 6 November 2020 the FDA announced the availability of the final guidance for industry and FDA staff.

The FDA is issuing this guidance document to comply with section 704 of the FDA Reauthorization Act of 2017 (FDARA) (Public Law 115-52), which amended section 801(e)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to specify the process afforded to persons denied a Certificate to Foreign Government (CFG) for a device.

This guidance describes the information that the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER), in collaboration with the Office of Regulatory Affairs (ORA), will provide to a person whose request for a CFG for a device is denied, and the process for seeking review of such a denial.

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Joint Guidance of Swissmedic and Swissethics on the Management of Clinical Trials with Medicinal Drug Products in Switzerland during the COVID-19 Pandemic
On 4 November 2020 Swissmedic and swissethics issued version 2.3 of their joint guidance.

Changes from version 2.2 (15.06.2020): changes made to the sections “Monitoring” (remote source data verification will be allowed under specific circumstances) and “Communication with Swissmedic”.

Swissmedic and swissethics recognize the impact the COVID-19 pandemic may have on the management and conduct of clinical trials. In the following, guidance is provided with respect to the management of clinical trials with medicinal drug products during the COVID-19 pandemic in Switzerland. The procedures described are aligned with the requirements laid down in the Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic (version 3 (28/04/2020) agreed to by the Clinical Trials Expert Group (CTEG) of the European Commission supported by the EMA, the Clinical Trials Facilitation and Coordination Group (CTFG) of the Heads of Medicines Agencies (HMA) and the GCP Inspectors’ Working Group coordinated by the EMA).

Due to the rapidly evolving situation, further updates to this guidance are possible and likely.

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EMA Updated Q&A: Good Clinical Practice (GCP)
On 3 November 2020 the EMA added a new Q&A (#14) to the GCP matters section.

The EMA provides guidance in the form of questions and answers (Q&As) on GCP, as discussed and agreed to by the GCP Inspectors Working Group.

“Does the sponsor of a clinical trial have the right to audit the manufacturer of the investigational medicinal product (IMP) even if the manufacturer has been subcontracted by a contract research organization (CRO) involved in the clinical trial?”

The question touches the scope of GCP as well as the scope of GMP. The main aspects of the question are whether sponsor oversight, as defined in ICH GCP E6 (R2) also extends to the manufacturing area, i.e. a GMP area and whether the contract between the CRO and subcontractors should include (or implicitly permit) that a sponsor audit is possible not only at the CRO, but also at the subcontractor.

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