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Focus on Regulation

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 use – ‟EU Regulationˮ) will enter into force on 23 October 2019. This new law was introduced through an amendment to the Pharmaceutical Law, of which the main elements have been described below.

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FCC Announces Participants in Auction 103

In a Public Notice released October 7, 2019, the Federal Communications Commission (FCC) announced the status of the 39 short-form applications for Auction 103, which is scheduled to begin on December 10, 2019. Auction 103 will offer 14,144 licenses covering some 3,400 megahertz of spectrum in the Upper 37 GHz, 39 GHz, and 47 GHz bands.

The FCC announced 29 complete and 10 incomplete applications for Auction 103. All applicants with complete applications will become qualified bidders upon receipt by the FCC of the required upfront payment by October 22, 2019. Applicants with incomplete applications must correct any deficiencies and remit the upfront payment by the October 22, 2019, deadline.

AT&T, Sprint, T-Mobile, US Cellular, Verizon, and DISH have filed to participate in the competitive bidding process.  None of the major cable companies appear to have submitted applications.

Applicants typically apply through subsidiaries, many of which have fairly inscrutable names.  But the FCC tracks real parties in interest, and the chart below compares the applicant name against the real parties in interest.

Complete Applications

Incomplete Applications

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 not identify or support any specific, proprietary system. The Committee rather discusses and gives responses in relation to some of the characteristics a system for direct data entry should present. The general principles outlined in the opinion could be applied to different scenarios and to other eSource DDC technologies. Specific characteristics of different systems may require specific evaluation. Continue Reading

California Enacts Another CCPA – Robocall Legislation

On October 2, 2019, California Governor Gavin Newsom signed the Consumer Call Protection Act of 2019 to address the rise in deceptive robocalls and protect California consumers from fraudulent calls.

The law requires telecommunications service providers to implement Secure Telephony Identity Revisited (STIR) and Secure Handling of Asserted information using toKENs (SHAKEN) protocols by January 1, 2021.  These protocols are designed to attest to the authenticity of caller identification data and provide service providers with information to help ensure that calls are not spoofed.  Carriers may also implement an “alternative technology” as long as it “provides comparable or superior capability to verify and authenticate caller identification for calls carried over an internet protocol network.”  Demonstrating a “good faith” effort to implement STIR/SHAKEN will serve as a defense against a claim that a service provider failed to meet the STIR/SHAKEN deadline.  The law does not require carriers to block calls. Continue Reading

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 the European Union at the end of October 2019, the UK Responsible Person would be the UK equivalent of the EU Authorised Representative the role of which will then disappear as regards the UK.

The Medical Devices Regulations 2019 (UK MDR 2019) amended the existing Medical Devices Regulations 2002 (UK MDR 2002) to create this new role. The UK MDR 2019 defines the “UK Responsible Person” as “a person established in the United Kingdom who acts on behalf of a manufacturer established outside the United Kingdom in relation to specified tasks with regard to the manufacturer’s obligations under these regulations“. This includes registering with the MHRA before a medical device is placed on the UK market.

2.            Responsibilities

The key responsibilities of the UK Responsible Person are Continue Reading

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 2017/745 (MDR) which will enter into application in May 2020.

Article 32 of the MDR provides that for implantable devices and for Class III devices, other than custom-made or investigational devices, manufacturers shall draw up a SSCP. Once drafted, the SSCP shall be validated by the relevant notified body which will then make it available to the public via the European database on medical devices (Eudamed).

2.            General requirements and recommendations for the SSCP

The Guidance includes a number of recommendations regarding the preparation of a SSCP. These include Continue Reading

The European Commission has published Guidelines concerning the use of phthalates in medical devices

The European Commission’s Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) has published Guidelines concerning the use of phthalates in medical devices.

The Guidelines concern the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates which are carcinogenic, mutagenic and toxic to reproduction (CMR) or have endocrine-disrupting (ED) properties.

The Guidelines have been drafted and adopted in light of the EU Medical Devices Regulation (MDR) which will be applicable on 26 May 2020 and are intended to be used by manufacturers, notified bodies and competent authorities.

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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 indication, including reasons underlying differences.

2.            High concordance

The study found a high level of concordance Continue Reading

Publication of rules on designation of expert panels under the Medical Devices Regulations

1.            Introduction

In the process of getting ready for the implementation of the forthcoming medical devices Regulations the European Commission published on 10 September 2019 the Commission Implementing Decision (EU) 2019/1396 (Decision) laying down rules on designation of expert panels in the field of medical devices. These expert panels are to be designated to provide scientific, technical and clinical assistance to the Commission, the Medical Device Coordination Group (MDCG), Member States, notified bodies and manufacturers under the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR). These expert panels will also be consulted by notified bodies as part of the conformity assessment of high-risk medical devices. Continue Reading

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 in order to justify such exemption and obligations of the qualified person for batch control. Continue Reading