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Feb 2, 2021

 
Overview of Comments Received on 'Draft Questions and Answers on Data Monitoring Committees Issues' (EMA/492010/2018)
On 29 January 2021 the EMA published the overview of comments on draft Q&A on Data Monitoring Committees Issues.

The aim of this question-and-answer document is to supplement the CHMP Data Monitoring Committee guideline (Doc. Ref. EMEA/CHMP/EWP/5872/03) by providing clarification on the role and necessity for a Data Monitoring Committee (DMC) in different phases of drug development and throughout the product lifecycle as well as with regard to the responsibilities for implementing DMC decisions.

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Coagulation Systems for Measurement of Viscoelastic Properties: Enforcement Policy During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised)
On 28 January 2021 the FDA published the final guidance for industry and FDA staff.

FDA is issuing this guidance to provide a policy to help expand the availability of coagulation systems for measurement of whole blood viscoelastic properties that are used to assess hemostasis, for the duration of the COVID-19 public health emergency. This document updates the guidance of the same title issued on January 14, 2021.

This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Secretary of Health and Human Services (HHS) on January 31, 2020, effective January 27, 2020, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service Act (PHS Act) (42 U.S.C. 247d(a)(2)).

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FDA Updated Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency
On 27 January 2021 the FDA updated the final guidance for industry, investigators and institutional review boards.

FDA is issuing 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.

This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Secretary of Health and Human Services (HHS) on January 31, 2020, effective January 27, 2020, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service Act (PHS Act) (42 U.S.C. 247d(a)(2)).

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Assent / Informed Consent Guidance for Paediatric Clinical Trials with Medicinal Products in Europe
On 25 January 2021 the European Network of Paediatric Research at the EMA’s (Enpr-EMA’s) Working Group on Ethics developed the guidance.

This document is intended to be used as an overview tool of the contents for assent/informed consent forms for all stakeholders (such as patients, sponsors and investigators) to support the conduct of high quality paediatric clinical trials in Europe across all paediatric age groups, from birth to less than 18 years of age.

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Commission Notice – Application of the Union’s Pharmaceutical Acquis in Markets Historically Dependent on Medicines Supply from or through Great Britain after the End of the Transition Period
On 25 January 2021 the EMA published the European Commission notice to stakeholders.

This guidance notice is intended to facilitate the application of the EU’s pharmaceutical acquis in markets historically dependent on medicines supply from or through Great Britain after the end of the transition period by indicating how the Commission will apply to this specific situation the relevant provisions of Directives 2001/82/EC, 2001/83/EC, 2001/20/EC of the European Parliament and of the Council and the Commission Delegated Regulation (EU) 2016/161.

The Commission has identified the following challenges (described below) as the principal difficulties for the abovementioned markets which are historically dependent on medicines supply from or through Great Britain in complying with the Union’s pharmaceutical acquis:

1. Lack of operators holding a manufacturing authorisation necessary for imports of medicinal products from third countries;

2. Difficulties to carry out quality control testing (‘batch testing’);

3. Difficulties to comply with the provisions of Directive 2001/83/EC and Delegated Regulation (EU) 2016/161 with respect to the placement and verification of the unique identifier.

Recognising these challenges, and taking into consideration the exceptional circumstances of the COVID-19 pandemic, the Commission takes note of the request, from both private and public stakeholders in the Union and the United Kingdom, for more time in the transition towards full compliance with the Union’s pharmaceutical acquis.

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Manufacturing Considerations for Licensed and Investigational Cellular and Gene Therapy Products During COVID-19 Public Health Emergency
On 19 January 2021 the FDA published the final guidance for industry.

FDA is issuing this guidance to provide manufacturers of licensed and investigational cellular therapy and gene therapy (CGT) products with risk-based recommendations to minimize potential transmission of the novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This guidance is intended to supplement the recommendations to drug and biological product manufacturers provided in FDA’s “Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing; Guidance for Industry” issued in June 2020 (Ref. 1) (June 2020 GMP Guidance). The recommendations in this guidance specifically consider the source material (cells and/or tissues) recovered from donors and how the CGT product will be manufactured (e.g., cell expansion in culture, viral reduction steps, formulation).

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Guidelines 01/2021on Examples Regarding Data Breach Notification
On 18 January 2021 the European Data Protection Board announced the notification for public consultation. Comments should be sent by 2 March 2021.

The General Data Protection Regulation (GDPR) introduces the requirement for a personal data breach to be notified to the competent national supervisory authority (hereinafter “SA”) and, in certain cases, to communicate the breach to the individuals whose personal data have been affected by the breach (Articles 33 and 34).

The Article 29 Working Party already produced a general guidance on data breach notification in October 2017, analysing the relevant Sections of the GDPR (Guidelines on Personal data breach notification under Regulation 2016/679, WP 250) (hereinafter “Guidelines WP 250”). However, due to its nature and timing, this guideline did not address all practical issues in sufficient detail. Therefore, the need has arisen for a practice-oriented, case-based guidance that utilizes the experiences gained by SAs since the GDPR is applicable.

This document is intended to complement the Guidelines WP 250 and it reflects the common experiences of the SAs of the EEA since the GDPR became applicable. Its aim is to help data controllers in deciding how to handle data breaches and what factors to consider during risk assessment.

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FDA Released Artificial Intelligence/Machine Learning Action Plan
On 12 January 2021 the FDA released the agency’s first artificial intelligence/machine learning (AI/ML)-based software as a medical device (SaMD) action plan.

This AI/ML-Based Software as a Medical Device action plan describes a multi-pronged approach to advance the Agency’s oversight of AI/ML-based medical software. It outlines five actions that the FDA intends to take, including:

  • Further developing the proposed regulatory framework, including through issuance of draft guidance on a predetermined change control plan (for software’s learning over time);
  • Supporting the development of good machine learning practices to evaluate and improve machine learning algorithms;
  • Fostering a patient-centered approach, including device transparency to users;
  • Developing methods to evaluate and improve machine learning algorithms; and
  • Advancing real-world performance monitoring pilots.

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