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Category Archives: Regulatory

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BIS publishes rules regarding CIV and APR license exceptions and military end use and military end user controls for China, Russia and Venezuela

Three important regulatory developments were published yesterday in the Federal Register by the Commerce Department’s Bureau of Industry and Security: A Final Rule eliminating the Civil End Users (CIV) license exception. The Final Rule goes into effect 29 June 2020. A Final Rule expanding license requirements for exports, reexports and in-country transfer for military end

Webinar | New TRACED Act and Robocall Year in Review: What you need to know

It was a very busy year on the robocall front, and on 30 December 2019, President Trump signed into law the Pallone-Thune Telephone Robocall Abuse Criminal Enforcement and Deterrence (TRACED) Act (S. 151), which the House and Senate passed by wide, bipartisan margins earlier this year. The TRACED Act is the most significant robocall legislation

European Commission publishes new documents regarding the Clinical Trials Regulation

1.            Introduction Shortly after updating the related draft Questions and Answers document (see our blog), the European Commission has published two new documents concerning the Clinical Trials Regulation (EU) 536/2014. The first document is an informed consent and patient recruitment procedure template. The second document is an updated clinical trial Application Form.

Engage is here!

Dear reader, We have moved all content related to Pharmaceutical, Biotechnology, and Medical Device and Technology regulations to the new Hogan Lovells knowledge platform Engage, which will give you the legal and regulatory insight and analysis you need, from across our global network, when you need it. Register here to continue receiving this content. We are

European Commission provides clarification regarding the implementation of the Clinical Trials Regulation

1.               Introduction The European Commission has published an updated Questions and Answers document concerning the Clinical Trials Regulation (EU) 536/2014. The document provides clarification regarding the implementation of the rules governing clinical trials within the Regulation. The draft document has been submitted for discussion to the Expert Group on Clinical Trials.

European Medicines Agency’s new guide on the wording of therapeutic indication

1.            Introduction On 21 October 2019, the European Medicines Agency (EMA) published a guide for assessors of centralised applications for marketing authorisation. The guide focuses on the wording used in therapeutic indications. The therapeutic indication is the primary information concerning the use of a medicinal product. The guide provides that therapeutic indications should clearly state

Heads of Medicines Agencies publishes practical guidance on nitrosamines

1.            Introduction In late October 2019, the Co-ordination Group for Mutual Recognition and Decentralised procedures – Human (CMDh) of the Heads of Medicines Agencies (HMA) published a practical guidance on nitrosamines. The guidance is addressed to marketing authorisations holders (MAHs) of products medicinal products authorised nationally in the EU Member States and through the mutual

Another step forward in digital health: FDA issues draft guidance for drug master files (DMFs) for electronics and software components of combination products regulated primarily as a drug

On Monday, the FDA published the draft guidance, “Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software,” which could facilitate drug manufacturers’ ability to integrate digital health tools which are regulated as medical devices.  The guidance describes when a Type V drug master file (DMF) can be used to

Poland: Implementation of the EU rules on falsified medicines

The new law implementing the EU rules on falsified medicines which has been applicable since February 2019 (Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human

What the European Medicines Agency’s qualification opinion means for electronic clinical data capture

1.            Introduction The European Medicines Agency (EMA) issued a qualification opinion following a request concerning proprietary eSource DDC (Direct Data Capture) technology. This technology allows the capture of clinical study source data electronically by investigator site staff at the point of care. In its opinion, EMA’s Committee for Medicinal Products for Human Use (CHMP) does

Publication of further guidance on the role of the “UK Responsible Person” in case of no-deal Brexit

1.            Introduction On 18 September 2019, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) published new guidance regarding the role and responsibilities of the “UK Responsible Person”. This is part of MHRA’s continued effort to regulate medical devices in the event of a no-deal Brexit. With the possible withdrawal of the UK from

New MDCG Guidance on Summary of Safety and Clinical Performance under the Medical Devices Regulation (MDR)

1.            Introduction On 26 September 2019, the European Commission published a new Guidance of the Medical Device Coordination Group (MDCG) concerning the Summary of Safety and Clinical Performance (SSCP). This document is aimed at manufacturers and notified bodies and provides guidance on the presentation, content and validation of the SSCP under the Medical Devices Regulation

New drug marketing applications: how do EMA and FDA compare?

1.            Introduction A newly-published study has compared more than a hundred new drug marketing applications at both the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) in the period 2014-2016. The study examined the differing outcomes of individual applications at the Agencies in terms of marketing approval, type of approval, and approved

European Medicines Agency’s clarification regarding re-testing exemption for imported advanced therapy medicinal products

1.            Introduction On 21 August 2019, the European Medicines Agency (EMA) published questions and answers regarding imported advanced therapy medicinal products (ATMP). The document focuses on the possibility of batch controls exemption for ATMP imported into the European Union from a third country. It provides guidance concerning grant of the exemption, data to be submitted

Medical Device Contractor Settles FCA Allegations Based on TAA Violations

On Thursday, August 8, 2019, the Department of Justice (“DoJ”) announced that Danish medical device company Ambu, Inc. (“Ambu”) will pay $3.3 million to settle False Claims Act (“FCA”) allegations that it violated the Trade Agreements Act (“TAA”) (19 U.S.C. § 2518) by selling products to the Defense Logistics Agency (“DLA”) and the Department of

European Commission draft implementing regulation on the reprocessing of single-use medical devices: public consultation is open

On 23 July 2019, the European Commission published the draft Commission Implementing Regulation (hereafter “Draft”) regarding Common Specifications for the reprocessing of single-use medical devices. The Draft is to implement the requirements of Article 17(3) of the Medical Devices Regulation 2017/943 (hereafter “MDR”). Article 17 MDR provides that under certain conditions, health institutions can reprocess

FDA and EMA Address Quality and Manufacturing Challenges for Breakthrough Therapies Undergoing Expedited Approval

On July 31, 2019, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) published a joint report on their efforts to support the development of and expedite access to breakthrough therapies that address unmet medical needs.  In addition to outlining the tools currently available to manufacturers seeking expedited approval of breakthrough

European commission publishes Additional Guidance regarding the Medical Devices Vigilance System

The three medical devices Directives, the Directive for Active Implantable Medical Devices (AIMD), the Directive for Medical Devices (MDD) and the In Vitro Diagnostic Medical Devices Directive (IVDD), provide for the requirement for a European Medical Devices Vigilance System. The Medical Devices Vigilance System is the European system for the notification and evaluation of incidents

Will FDA be forced to implement a drug importation program?

Over a year ago, HHS Secretary Alex Azar requested that FDA establish a working group to explore how drug importation “could help address price hikes and supply disruptions.” The FDA working group was not assigned the task of developing a broad drug importation program. Instead, the working group’s remit was specifically limited to considering potential

FDA launches temporary “TRIP” program to help HCT/P sponsors gain regulatory clarity

Acting Food and Drug Administration (FDA) Commissioner Ned Sharpless, M.D. recently announced that FDA is implementing a temporary program called the Tissue Reference Group Rapid Inquiry Program (“TRIP”), which will assist human cell, tissue, and cellular and tissue product (HCT/P) manufacturers, as well as stakeholders that market HCT/Ps, to “obtain a rapid, preliminary, informal, non-binding assessment from

FDA issues benefit-risk framework for assessing opioid drug applications, announces public meeting

Agency seeks input on “comparative advantage” requirement for new opioids Yesterday, as part of its ongoing efforts to combat the current opioid crisis, FDA published a draft guidance, “Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework,” outlining the benefit-risk framework the Agency intends to use in assessing whether a new opioid drug application meets the

What comes out, must go back in: Court sides with FDA on “same surgical procedure” and “homologous use” definitions governing human cell and tissue products

FDA authority to crack down on illegally marketed stem cell treatments confirmed On Monday, a federal District Court in Florida issued a decisive blow against US Stem Cell Clinic, LLC, granting the U.S. Food and Drug Administration’s (FDA) motion for summary judgment, and stopping the clinic from offering its stem cell therapy to patients. The

FDA’s ‘Project Facilitate’ Pilot to Collect Metrics on Sponsor Expanded Access Denials

This morning, FDA announced it launched its new expanded access pilot called “Project Facilitate,” a concierge call center under the Oncology Center of Excellence (OCE) to facilitate the Single Patient IND (SPI) request process for oncologists.  Under the new program, FDA staff will help guide physicians through the process of applying for expanded access by

NHTSA, FMCSA release advanced notices of proposed rulemaking regarding autonomous driving systems

The National Highway Traffic Safety Administration (NHTSA) and Federal Motor Carrier Safety Administration (FMCSA) today each issued an advanced notice of proposed rulemaking (ANPRM) regarding the removal of regulatory barriers to the safe introduction of automated driving systems (ADS) on public roads. I. NHTSA’s ANPRM NHTSA’s ANPRM focuses on how to amend its crash avoidance