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Dec 16, 2020

 
Questions and Answers to Stakeholders on the Implementation of the Protocol on Ireland / Northern Ireland
On 11 December 2020 the EMA Published Revision 2 of the Q&A Document.

The information provided in this Q&A document complements the Notice to Stakeholders on the Withdrawal of the UK and EU rules for medicinal products for human use and veterinary medical products and the EMA Practical guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralized procedure.

This practical guidance document only reflects the situation as laid down in legal provisions in force on the date of its publication, and without prejudice to any of the ongoing discussions between the European Union and the UK concerning the application of the Union acquis concerning medicinal products with respect to Northern Ireland after the transition period, in light of the particular challenges that small markets historically dependent on medicines supplied from or through Great Britain are facing. In this regard it has to be kept in mind that the EMA is not participating in any of the negotiations between the Union and the UK that aim at solving – before the end of 2020 - the particular challenges that small markets face that historically are dependent on medicines supplied from or through Great Britain, notably Northern Ireland.

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Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway
On 11 December 2020 the FDA Issued the Final Guidance for Industry and FDA Staff.

This guidance provides performance criteria for non-spinal metallic bone screws and their associated washers in support of the Safety and Performance Based Pathway. Under this framework, submitters planning to submit a 510(k) using the Safety and Performance Based Pathway for non-spinal metallic bone screws and washers, will have the option to use the performance criteria proposed in this guidance to support substantial equivalence, rather than a direct comparison of the performance of the subject device to that of a predicate device.

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Best Practices in Developing Proprietary Names for Human Prescription Drug Products
On 9 December 2020 the FDA Announced the Availability of the Final Guidance for Industry.

FDA is issuing this guidance to help sponsors of human prescription drug products develop proprietary names for those products. This guidance describes best practices to help minimize proprietary name-related medication errors and otherwise avoid adoption of proprietary names that contribute to violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its implementing regulations. It also describes the framework FDA uses in evaluating proposed proprietary names that is also available to sponsors to use before submitting names for FDA review if they wish. This guidance does not address the designation of established names or proper names.

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Clinical Trials Information System (CTIS) Highlights – December 2020
On 9 December 2020 the EMA Published Issue 2 of CTIS Highlights.

This newsletter highlights news, views and interviews for the CTIS including:

  • CTIS benefits: digitalization and improved efficiency, increased transparency, enhanced patient safety, support of innovation and research
  • CTIS features – user administrator & roles
  • Interaction member states – sponsors
  • CTIS training focusing on online materials
  • Audit

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The eCTD v4.0 Q&A v1.4 Reaches Step 4 of the ICH Process
On 9 December 2020 the ICH Announced eCTD v4.0 Reaches Step 4.

The eCTD v4.0 Question and Answer (Q&A) and Specification Change Request Document v1.4 reached Step 4 of the ICH process in December 2020.

The eCTDv4.0 Q&A document is a summary of questions reviewed by the eCTD Implementation Working Group (i.e. M8 IWG) on the eCTDv4.0 Implementation Package, as well as new Change Requests submitted in 2020, the M8 EWG/IWG has updated the eCTD v4.0 Q&A to version 1.4.

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European Medicines Agencies Network Strategy to 2025
On 8 December 2020 the EMA Published the Joint Strategy Setting Direction for EMA and EU Medicines Regulatory Agencies to 2025.

EMA and the Heads of Medicines Agencies (HMA) have published their joint strategy for the next five years, following its recent adoption by the HMA and EMA Management Board.

The strategy details how the European medicines regulatory network can continue to enable the supply of safe and effective medicines that meet patients’ needs in the face of challenges posed by ever-accelerating developments in science, medicine, digital technologies, globalization as well as emerging health threats, such as the COVID-19 pandemic.

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Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products; Draft Guidance for Industry
On 8 December 2020 the FDA Announced the Availability of the Draft Guidance for Industry.

FDA is issuing this guidance to help sponsors of human nonprescription drug products develop proprietary names for those products. This guidance describes best practices to help minimize proprietary name-related medication errors and otherwise avoid adoption of proprietary names that contribute to violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its implementing regulations. It also describes the framework FDA uses in evaluating proposed proprietary names that is available to sponsors to use for nonprescription drug products before a product bearing that proprietary name is marketed. This guidance does not address the designation of established names or proper names.

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MHRA Updated Guidance on Regulating Medical Devices from 1 January 2021
On 7 December 2020 the MHRA Updated the Medical Devices Guidance.

From 1 January 2021 the Medicines and Healthcare products Regulatory Agency (MHRA) will be responsible for the UK medical devices market that are currently managed through the EU system.

This guidance provides information on how the UK system will operate, including for:

  • Getting your device certified
  • Conformity marking your device
  • Registering your device with the MHRA

This guidance is divided into sections on the different rules that will apply in Great Britain, Northern Ireland and the EU. Great Britain is England, Wales and Scotland.

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Reflection Paper on Patient-Focused Drug Development for Public Consultation
On 7 December 2020 the ICH Published the Reflection Paper on PFDD for Public Consultation by 7 March 2021.

The ICH Reflection Paper on Patient-Focused Drug Development (PFDD) was endorsed by the Assembly in November 2020.

This Reflection Paper identifies key areas where incorporation of the patient’s perspective could improve the quality, relevance, safety and efficiency of drug development and inform regulatory decision making. It also presents opportunities for development of new ICH guidelines to provide a globally harmonized approach to inclusion of the patient’s perspective in a way that is methodologically sound and sustainable for both regulated industry and regulatory authorities.

As part of ICH public consultation on this Reflection Paper, stakeholders are invited to provide their comments to their respective Regulatory Authorities or directly to the ICH Secretariat by 7 March 2021 at pfdd@ich.org.

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Update to FDA Guidance on Conduct of Clinical Trials of Medical Products During COVID-19 Public Health Emergency
On 4 December 2020 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.

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Requesting FDA Feedback on Combination Products
On 3 December 2020 the FDA Announced the Availability of the Final Guidance for Industry and FDA Staff.

The purpose of this guidance is to discuss ways in which combination product sponsors can obtain feedback from FDA on scientific and regulatory questions and to describe best practices for FDA and sponsors when interacting on these topics. These interactions can occur through application-based mechanisms, such as the pre-submission process used in the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) and the formal meetings used in the Center for Drug Evaluation and Research (CDER) and CBER, or through Combination Product Agreement Meetings (CPAMs), as appropriate.

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