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Category Archives: Health

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New version of EMA’s pre-authorisation procedural advice for the centralised procedure released

On 4 May 2018, the European Medicines Agency (“EMA”) published another updated version of the guidance document on pre-authorisation for users of the centralised procedure. The document contains revisions regarding the EMA marketing authorisation application numbers. It also includes changes related to oral explanations during the assessment procedure of the marketing authorisation application. Background The

FDA Shows that it Means Business in Stopping Stem Cell Clinics that Put Patients at Risk

On Wednesday, FDA announced that it filed two complaints in federal court seeking injunctions to stop marketing efforts of unapproved stem cell treatments by US Stem Cell Clinic of Sunrise, Florida, and California Stem Cell Treatment Center, alleging the treatments seriously harmed patients. Both lawsuits follow up on prior actions that FDA initiated against these

The evolution of CBD in South Africa

During the past several decades, the advances made in the life sciences and health care industries have been astounding, not to mention revolutionary. A presently obscure and experimental treatment may, in a day or week or years’ time, become a miraculous cure. Imagine the ridicule faced by Peyton Rous when he suggested that cancers have

Belgian sunshine rules – Submissions required by 31 May 2018 at the latest

On 27 December 2016, the Belgian Law of 18 December 2016 concerning various health-related matters (“the Sunshine Act”) was adopted by the Belgian Ministry for Public Health. The Sunshine Act provides that life sciences companies must publically disclose information concerning all pecuniary advantages or benefits in kind granted, directly or indirectly from Belgium or elsewhere,

Boost for digital health in Germany – restrictions on remote treatment could be overturned in May 2018

At the next Annual General Meeting of the German Medical Association (Deutscher Ärztetag), the current restrictions on remote treatment by German physicians will most likely be overturned. Until now, physicians in Germany were only allowed to offer follow-up treatment by telemedicine (e.g. video consultation) if the patient had already been treated in their practice before.

New UK-Wide Model Clinical Trial Agreements Published

An updated Model Clinical Trial Agreement (mCTA) has been published for industry-sponsored clinical trials involving patients in National Health Service (NHS) or Health and Social Care (HSC) hospitals in the UK. The mCTA is a standard form contract which is intended to be used by clinical trial sponsors and NHS/HSC organisations without modification. Previously, under

Brexit – what’s next for medical devices?

On 22 January 2018, the European Commission released a notice to stakeholders concerning the United Kingdom’s (“UK”) possible withdrawal from the European Union (“EU”) and the EU rules in the field of industrial products, including medical devices and in vitro medical diagnostic medical devices. The notice presents the steps that manufacturers of medical devices and

UK Government Announces Life Sciences Sector Deal

The UK government has published a White Paper setting out its new Industrial Strategy and, as part of that strategy, has agreed a Sector Deal with the UK life sciences sector. The White Paper covers all industries and identifies the life sciences sector as having particular strategic value in the UK, generating £64 billion of

FDA Clarifies and Expands Eligibility for RMAT Designation for Gene Therapies

On November 16, in the context of announcing a comprehensive regenerative medicine policy framework (discussed here), FDA released a draft guidance document that describes the expedited programs available for the development and review of certain regenerative medicine therapies.  Importantly, the draft guidance clarifies certain aspects of the Regenerative Medicine Advanced Therapy (RMAT) designation established by

FDA Issues New Guidance Documents on Regenerative Medicine but Delays Enforcement

Yesterday, the U.S. Food and Drug Administration (FDA) announced a comprehensive framework for development and oversight of regenerative medicine products, including innovative cell-based therapies.  This initiative builds on the agency’s existing framework to set forth more clearly which products are subject to regulatory enforcement. In September, as we previously discussed here and here, FDA’s Commissioner,

UK Advice on Mental Health in Advertising

On the back of a number of high profile initiatives to raise awareness of mental health issues in the UK this year, the UK Committee of Advertising Practice (CAP) has published a timely reminder for advertisers of how mental health is addressed under the UK advertising rules (the CAP and BCAP Codes). There is no

UK MHRA Issues New Guidance on Human Factors and Usability Engineering for Medical Devices

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published new guidance on taking human factors into account when designing medical devices and ensuring that they meet the essential safety and performance requirements for devices. ‘Human factors’ refers to how a person uses or interacts with a device taking into account the context and

UK MHRA Publishes Guide to the New EU Medical Device and IVD Regulations

The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published an interactive guide to assist companies with understanding the requirements of the new EU Medical Device Regulation (“MDR”) and In Vitro Diagnostic Medical Device Regulation (“IVDR”). The MDR and IVDR entered into force on 25 May 2017. Most of the requirements under the MDR

FDA, EU Regulators Agree to Share Unredacted Inspection Reports and Other Confidential Information

The U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the European Commission – DG Sante (DG Sante), signed a new confidentiality commitment which expands the scope of the current confidentiality arrangements that apply to the cooperative law enforcement activities conducted by the regulators.  The new confidentiality commitment allows the regulators to share

House Subcommittee on Health Opens Floor for Discussion of FDA Regulation of Off-Label Speech

The House Subcommittee on Health has announced a hearing entitled “Examining Medical Product Manufacturer Communications” for Wednesday, July 12, 2017, at 10:15am EDT, in which it intends to examine two discussion-draft bills seeking to amend the Federal Food, Drug, and Cosmetic Act (“FDCA”) to clarify how drug and device manufacturers can legally discuss uses of

New UK Brexit Health Alliance Formed

A “Brexit Health Alliance” (BHA) has been formed to bring together a diverse range of UK stakeholders in the healthcare industry and provide a single voice for the sector on Brexit-related issues. Members of the BHA include NHS organisations, industry associations, universities, research organisations and charities, the Royal Colleges, such as NHS Confederation, NHS Providers,

French Sunshine Regulations: The Puzzle Now Completed and in Force

The French sunshine regulations require industry to report certain agreements along with the fees and other benefits provided to various stakeholders in the healthcare sector. Sunshine regulations were amended in January 2016 to increase transparency. Some specifics of these changes were partly established by an implementing decree dated 28 December 2016. Through the publication of

UK to Seek Close Relationship with EMA Post-Brexit

UK Secretary of State for Health, Jeremy Hunt, has stated in a Health Select Committee meeting that he does not expect the UK to remain part of the European Medicines Agency (“EMA”) or the EU medicines regulatory framework post-Brexit, but that the UK should seek a very close working relationship with the EMA and the

What’s ahead with the new Trump administration?

It’s no secret that the life sciences industry has had some challenging moments with lawmakers in recent years. And despite efforts by the White House, Congress, FDA, and other regulatory agencies, in most cases the law continues to lag behind the industry’s pace of innovation. So, how will the Trump Administration address the industry’s challenges?

UK MHRA to develop quality standards for biological medicines

The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published a draft strategy for developing pharmacopoeial public quality standards for biological medicines. Public quality standards form part of the regulatory framework governing the quality of all medicines. Both documentary and physical standards exist to ensure that medicines are of acceptable quality for use by