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Jul 16, 2020

Providing Regulatory Submissions for Medical Devices in Electronic Format — Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act
On 15 July 2020 the FDA issued the final guidance for industry and FDA staff.

In section 745A(b) of the FD&C Act, Congress granted explicit statutory authorization to the FDA to specify guidance for the electronic submissions requirement by providing standards, criteria for waivers and exemptions, and a timetable for such submissions.

This document provides guidance on FDA’s interpretation of the statutory requirement for submission in electronic format; this document also contains guidance on additional submission types for which submission in electronic format is anticipated to be recommended.

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China NMPA Guidance on the Management of Clinical Trials of Medical Products During COVID-19 Pandemic
On 14 July 2020 the Chine NMPA issued the draft guidance in Chinese for sponsors and investigators.

In order to standardize the clinical trials of drugs during COVID-19 pandemic in China and provide effective safety management measures, under the deployment and approval of the National Medical Products Administration (NMPA), the NMPA Drug Review Center has issued the draft guidance, which is in effect on the date of release.

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Cancer Clinical Trial Eligibility Criteria: Minimum Age Considerations for Inclusion of Pediatric Patients
On 10 July 2020 the FDA announced the availability of the final guidance for industry and IRBs.

This guidance is one in a series that provides recommendations regarding eligibility criteria for clinical trials of drugs or biological products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) for the treatment of cancer. Specifically, this guidance includes recommendations regarding the inclusion of pediatric patients (i.e., children and adolescents) when appropriate. This guidance is intended to assist stakeholders, including sponsors and institutional review boards (IRBs), responsible for the development and oversight of clinical trials.

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Technical Notice to Sponsors Regarding Continuous Compliance with the EU Legislation for Clinical Trials Following the Withdrawal of the United Kingdom from the EU
On 9 July 2020 a joint technical notice to sponsors by the European Commission, EMA and HMA was published.

The purpose of this technical notice is to remind sponsors of clinical trials conducted in the EU Member States, of the legal situation applicable after the end of the transition period on 31 December 2020, as described in the Commission Brexit readiness notice regarding Clinical Trials.

According to Article 13(2) of Directive 2001/20/EC, the qualified person has to be established in the EU/EEA. Investigational medicinal products used in clinical trials can be imported only after their batch-release has been certified by a qualified person in the EU. According to Article 19 of Directive 2001/20/EC, the sponsor of a clinical trial or a legal representative must be established in the EU.

In addition, for trials authorised in at least one Member State where the sponsor is established in a third-country and with a legal representative in the UK, the sponsor needs to establish its legal representative in the EU by the end of the transition period. At the end of the transition period, the sponsor or its legal representative has to be established in the EU for all ongoing trials. Failure to meet this requirement will be a breach of Directive 2001/20/EC and could trigger a request for corrective actions by Member State competent authorities.

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Procedural Advice for Post-orphan Medicinal Product Designation Activities
On 3 July 2020 the EMA published revision 8 of the guidance for sponsors.

This guidance covers the information and procedures applicable to orphan designated products:

  • incentives
  • annual reports
  • transfer of sponsorship
  • change of sponsor’s name or address
  • amendment of designated condition
  • marketing authorisation application
  • review of the maintenance of orphan medicinal product designation at the time of marketing authorisation application
  • review of the maintenance of orphan medicinal product designation at the time of extending the therapeutic indication post-authorisation
  • withdrawal of orphan designation

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Annual Report of the Pharmacovigilance Inspectors Working Group for 2018
On 2 July 2020 the EMA announced the availability of the 2018 PV annual report.

A total of 255 pharmacovigilance inspections were conducted for human medicinal products in 2018 in EU/EEA. Of these, 47 human pharmacovigilance inspections were requested in 2018 in the context of supervisory authority inspections of marketing authorisation holders (MAHs) with centrally authorised products (CAPs).

A total of 175 findings, 18 critical (10,3%) and 157 major (89,7%), were identified during the supervisory authority inspections conducted in 2018 (period covering 01/01/2018 to 31/12/2018). These numbers include both supervisory authority inspections of MAHs with CAPs requested by the Committee for Medicinal Products for Human Use (CHMP) and supervisory authority inspections that were conducted under national inspection programmes.

The three most common areas with findings were:

  • Management and reporting of ICSRs;
  • Quality assurance;
  • Signal management.

There were no critical or major findings related to local qualified persons responsible for pharmacovigilance (QPPV).

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Updated FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency
On 2 July 2020 the FDA updated the final guidance for industry, investigators and IRBs.

FDA issued this guidance to provide general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity for the duration of the COVID-19 public health emergency. The appendix to this guidance further explains those general considerations by providing answers to questions that the Agency has received about conducting clinical trials during the COVID-19 public health emergency. A new Q&A (#12) section has been added about the alternative process to obtain informed consent when electronic and paper forms cannot be provided.

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Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking
On 1 July 2020 the FDA issued the immediately in effect guidance for industry and FDA staff.

This guidance describes FDA’s intention regarding enforcement of these requirements for class I and unclassified devices.

This guidance also describes FDA’s direct marking compliance policy for class III, LS/LS, and class II devices that are non-sterile, that are manufactured and labeled prior to their applicable direct marking compliance date, and that remain in inventory, as well as for class I and unclassified devices that are not LS/LS devices, that are non-sterile, that are manufactured and labeled prior to September 24, 2022, and that remain in inventory.

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