Your guide to the latest Hill developments, news narratives, and media headlines provided by the Hogan Lovells Government Relations and Public Affairs team. In Washington: Senate Republicans are beginning to put together their own fifth COVID-19 aid package, but with no apparent Democratic involvement it’s unlikely to receive enough support to pass both chambers, according to
On 24 June 2020, the United States Department of Defense made public a list of Chinese companies operating in the U.S. that are associated with the Chinese military. The Department of Defense has been legally required to maintain such a list under Section 1237 of the 1999 National Defense Authorization Act. The Act requires the
Your guide to the latest Hill developments, news narratives, and media headlines provided by the Hogan Lovells Government Relations and Public Affairs team. To read our recent client alert “House and Senate considering bills to enhance flexibility for PPP borrowers” click here. This is a revision of the May 22 client alert, which was updated due
Representative Jim Banks introduced a bill on 5 May 2020 to “place temporary restrictions on acquisitions [of U.S. companies] by the People’s Republic of China. . .” during the COVID-19 pandemic. The bill would mandate, with certain exceptions, that the Committee on Foreign Investment in the United States (CFIUS) review, and the President deny, certain
Amidst the global COVID-19 pandemic many things are uncertain. For businesses, this is further compounded by the rapidly changing and temporary measures that governments are launching to limit the financial fallout of the outbreak. To ensure businesses are not accidently caught out by these new measures, it is important for companies importing and exporting goods
Digital health offers huge potential for improving care and alleviating the increasing burden on our over-stretched healthcare systems. However, its uptake remains slow and varies significantly across the EU.
Dear reader, On December 2, we will begin publishing all content related to Medical Devices, Pharmaceutical, and Biotechnology regulations on our new knowledge platform: Hogan Lovells Engage. We are gradually moving all other blog content to Engage as well, but while we are making this transition, you will continue to be able to find all
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
The construction and further development of infrastructure is of crucial importance for society and a healthy economy. But protecting the environment and human rights has also come to the forefront of the global agenda. At times these two goals have been cast as mutually exclusive, but the financing community has recognized the imperative to harmonize
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued updated guidance on how the UK would regulate medicines, medical devices and clinical trials in the event that the UK leaves the EU on 29 March 2019 with no withdrawal arrangements in place, referred to as a “no deal” scenario. The guidance updates the
It’s been almost a year since the new “Internet clause” in China’s Anti-Unfair Competition Law (AUCL) is in force. The enforcement authority hasn’t used it much in 2018. But one decision is noteworthy. AUCL amendment On 1 January 2018, the first amendment to the AUCL since its enactment in 1993 came into effect. One of
The new Belgian Royal Act of 9 January 2018 on Biobanks will apply on 1 November 2018. The Royal Act implements Article 22 of the Belgian Law of 19 December 2008 on the procurement and use of human body material for human medical applications or for scientific research purposes. Scope and requirements The biobank legislation
The European Commission, together with the EMA and the expert group of the competent authorities of the EU Member States, has developed draft guidelines (the “Guidelines”) governing good clinical practice specific to advanced therapy medicinal products (“ATMPs”). The purpose of the Guidelines is to adapt existing good clinical practice rules (“GCPs”) to ATMPs. This step
In the recently published White Paper governing the future relationship between the United Kingdom and the European Union, the UK proposes a “common rulebook” between the parties in relation to goods. The White Paper discusses what is foreseen as the future relationship between the parties in some detail.
On 27 July 2018, the European trade association representing the medical technology industries, MedTech Europe, issued a position paper in which the association requests the European Commission, the European Parliament and all EU Member States to have an urgent discussion concerning the timelines for the application of the Medical Devices Regulation (MDR) and In Vitro
The EMA has announced that, from 15 June 2018. The Agency will cease to accept requests for access to documents by non-EU applicants. The EMA announced that the Agency’s decision was a result of the high volume of access requests and the related excessive administrative workload.
In a move to cement London’s reputation as “the” global legal centre, on 4 July 2018 a new flagship court was announced by Lord Chancellor David Gauke. The new court will specialise in (among other things) cybercrime, fraud and economic crime. This is heavy investment to ensure that the UK remains the centre for tech-based
By decision No. 10892 published on 7 May 2018, the Italian Supreme Court ruled on an appeal brought by the Ministry of Health against a decision of the appellate Court of Padua in a case concerning the administrative sanctions imposed by the Ministry of Health on the manufacturer and the editorial director of a TV
In a recently issued draft guidance for industry, FDA encourages drug sponsors to consider the inclusion of pregnant subjects in clinical studies evaluating drugs and therapeutic biological products in some circumstances and examines the specific ethical and scientific considerations that may impact this decision.
The conduct of clinical trials still relies heavily on the use of paper documents. Of course, electronic case report forms (eCRF) have been commonly used for many years – the medical information on a patient that is transferred from the clinical trial sites (hospitals/HCPs) to the sponsor (i.e. pharma or device company) is transmitted in electronic form.
In the EU, digital health technologies such as medical apps or wearable sensors can fall within the scope of the medical devices directives. These directives provide the basic definition of a medical device and lay down the technical and procedural obligations that must be followed by the manufacturer of a medical device prior to affixing a CE mark to the product.
Many digital health products are regulated by the U.S. Food and Drug Administration (FDA) as medical devices or, when used in conjunction with a specific drug or biological product, as combination products requiring clearance or approval from the agency prior to marketing.
On Feb 27th, China Food and Drug Administration (CFDA) published their inspection reports for the following eight international medical device manufacturers under its Medical Device Good Manufacturing Practice.
The Irish Health Products Regulatory Authority (HPRA) has published a Guide for Distributors of Medical Devices (“Guide”) in which the HPRA provides useful recommendations concerning the obligations that must be met by distributors in relation to the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR).