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Focus on Regulation

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 the disease/condition and population that a medicinal product is intended to treat. The objective of the guide is to provide a consistent approach in defining therapeutic indication. Therefore, it provides guidance concerning appropriate wording that may be applied across therapeutic areas.

2.            Regulatory framework

The guide provides clarification concerning the regulatory framework surrounding the assessment of the therapeutic indication. According to Article 8.3 (j) of Directive 2001/83/EC and Article 6.1 of Regulation (EC) 726/2004, a Summary of Product Characteristics (SmPC) prepared in accordance with Article 11 of Directive 2001/83/EC must be drafted and included in the application for marketing authorisation. The SmPC is the basis for information to health care professionals and patients.

Section 4.1 of the SmPC guideline contained in Volume 2C Notice to Applicants provides that the therapeutic indication should be stated clearly and concisely. In addition, the therapeutic indication should define:

  • the target disease, or condition distinguishing between treatment, prevention and diagnostic indication;
  • when appropriate, the target population, especially when restrictions to the patient population apply;
  • when relevant, any mandatory conditions of product usage not covered more appropriately in other parts of the SmPC.

3.            Elements to be considered when assessing the indication

The guide provides that the definition of therapeutic indication requires the analysis of several aspects that influence the benefit/risk assessment. The assessment of the indication should take into account the data submitted as part of the application. It should also take into account the therapeutic context and whether the benefits and risks in the studied population are applicable to the proposed target population.

The guide provides a number of components to consider when deciding on the wording of the indication:

  • Target disease or condition. This includes the effect of the medicinal product and information on duration of treatment;
  • Target population. This includes the evaluation as whether the benefit/risk balance is positive or not in relevant subgroups of the target population;
  • The place in therapy to evaluate if there is a defined treatment pathway ;
  • Use in monotherapy or combination therapy;
  • Mandatory condition of product usage.

The guide provides that even though these components can be applied to most therapeutic areas, they may be more or less relevant depending on the medicinal product. Other components not covered by the guide may be relevant as the exact wording of the indication remains a case-by-case evaluation.

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 recognition and decentralised procedures. The guidance provides the steps to be followed to evaluate the risk of the presence of nitrosamine impurities in human medicinal products. The guidance includes the contact details of the competent authorities of the individual EU Member States and their published guidance in Annex.

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Next step in rolling out Vietnam’s new competition regime

On 1 July 2019, Vietnam’s new Law on Competition (“Competition Law“) took effect. On 26 September 2019, the government issued the first implementing instrument, Decree No. 75/2019/ND-CP (“Decree 75“). Decree 75 is the first of a series of three implementing decrees that government is expected to enact to give guidance on how the Competition Law is to be enforced in practice.

The main goal of Decree 75 is to lay out more specific rules on administrative sanctions, but also contains useful guidance on other aspects. Decree 75 will take effect on 1 December 2019 and will repeal previous Decree No. 71/2014/ND-CP. Continue Reading

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 provide information to the Center for Drug Evaluation and Research (CDER) about a device constituent part with electronics and/or software that is planned for use as a platform across multiple CDER-led combination products.

The types of functions these device constituent parts could perform include: Continue Reading

Germany’s proposed digital antitrust law: an ambitious project to regulate digital markets

Germany is about to implement an ambitious new “digital antitrust law” (“GWB-Digitalisierungsgesetz”) to effectively regulate online markets. The draft Ministerial bill on the 10th amendment of the German Act Against Restraints of Competition (“GWB”), published at the beginning of October, aims at continuing Germany’s role as a pioneer in antitrust regulation of digital markets.

Regulation of digital markets – the broader context

“Divesture”, “Break up”, or “Regulation” of tech players. Political statements and requests on how to deal with “Tech Giants” from Silicon Valley or China have become more frequent, especially over the last 12 months. According to our global study on regulation of technology markets, there were more than 450 political initiatives in the first half of 2019 which supported a tougher regulatory stance on “Big Tech”. However, so far most of these fairly populist proposals lack implementation. Continue Reading

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