Archives: Food & Drug Regulatory

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The European Commission Announces a Sustainable Food Strategy for Europe

The COVID-19 pandemic has focused attention on the need for resilient supply chains, including perhaps most importantly, the critical need for  sustainable supplies of healthy food.  In line with this, the European Commission (the “Commission) has published a Communication on a Farm to Fork Strategy (the “Strategy”) where it announces a series of legislative and … Continue Reading

Commission Publishes Further Guidance on Clinical Trial Conduct During COVID-19 Pandemic

On 28 April 2020, the European Commission published further Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) Pandemic (the “Guidance”), supported by the European Medicines Agency (EMA) and the national Heads of Medicines Agency (HMA).  The Guidance is an update to the previous version published in late March (see InsideEULifeSciences blog post … Continue Reading

Effective date of EU Medical Device Regulation now officially delayed by 1 year

On 23 April 2020, the European Parliament and Council approved the European Commission’s proposal to delay the application date of the Medical Device Regulation 2017/745 (the “MDR”) by one year (from 26 May 2020 to 26 May 2021) by adopting New Regulation (EU) 2020/561 (the “New Regulation“). Unusually, the New Regulation took effect on the … Continue Reading

Ireland’s HPRA to fast-track review of Covid-19 related Clinical Trials and Clinical Investigations

The Irish Health Products Regulatory Authority (HPRA) today announced the introduction of an expedited review process for human health research related to COVID-19. The Irish Minister for Health also announced the setting up of a dedicated COVID-19 National Research Ethics Committee (NREC-COVID-19). Applications for clinical trials of human medicines or clinical investigations of medical devices … Continue Reading

Belgium replaces COVID-19 medicines export ban to non-EEA countries with system of export control

As previously reported on this blog, on 1 April 2020 Belgium adopted a complete ban on exports of certain medicines and raw materials to non-EEA countries to avoid shortages during the COVID-19 outbreak. On 8 April 2020, Belgium reversed this ban, and instead installed a system of export controls. Coincidentally or not, the same day … Continue Reading

European Commission Publishes Exceptional Antitrust Guidance for Undertakings Collaborating to Address the Shortage of Essential Products and Services during COVID-19

On 8 April 2020, the European Commission published its Communication on the “Temporary Framework for assessing antitrust issues related to business cooperation in response to situations of urgency stemming from the current COVID-19 outbreak” (the “Framework“). The Commission recognizes that supply chains have been severely disrupted due to COVID-19, combined with “an asymmetric demand shock … Continue Reading

European Commission issues Guidelines on the rational supply of medicines to avoid shortages during the COVID-19 crisis, calls for lifting export bans within the EU

As reported previously on this blog, several member states have imposed bans, requisitioned stock and applied various other control measures on medicines and protective equipment (e.g., Belgium, Bulgaria, the Czech Republic, France, the Netherlands, and Poland). On 8 April 2020, the European Commission (“Commission”) issued Guidelines on the optimal and rational supply of medicines to … Continue Reading

Belgium adopts export ban on certain medicines to non-EEA countries and other measures to avoid COVID-19 shortages

1. Summary On 1 April 2020, the Belgian Federal Authority for Health and Medicinal Products (“FAMPH”) adopted a Decision to avoid shortages of medicines and raw materials used in the treatment of COVID-19.  It applies for one month from 1 April, renewable.  On 2 April 2020, the authority provided further details in a news post … Continue Reading

European Commission publishes proposal to postpone the application date of the Medical Device Regulations in response to COVID-19

The European Commission published today its proposal for the European Parliament and the Council to postpone the application date of the Medical Devices Regulation 2017/745 (“MDR”) by one year.  This publication comes only 9 days after the Commission announced its plans to postpone the MDR (see the InsideEULifeSciences blog post here).  The European Parliament and … Continue Reading

The Italian Medicines Agency publishes Guidance on the management of clinical trials in Italy during the COVID-19 emergency

On March 12, 2020, the Italian Medicines Agency (“AIFA”) has provided guidance on the management of clinical trials due to the COVID-19 emergency.  The Guidance, which is addressed to CROs, Sponsors and non-profit organizations involved in clinical trials, allows for some derogations to support them face the criticalities.  The Guidance is intended to ensure that … Continue Reading

European Commission plans to postpone the application date of the Medical Device Regulations in response to COVID-19

The European Commission has announced today that it is working on a proposal to postpone the application date of the Medical Devices Regulation 2017/745 (“MDR”) for one year.  This proposal is to relieve the pressure on national authorities, notified bodies, manufacturers and other actors so they can focus on responding to the COVID-19 outbreak.  According … Continue Reading

MHRA announces a risk-based prioritisation of on-site Good Practice inspections during COVID-19

On 20 March 2020, the Medicines and Healthcare products Regulatory Agency (“MHRA”, the “Agency”) announced it will be conducting only ‘essential’ on-site Good Practice (“GxP”) inspections of laboratories, clinical trials, manufacturing, distribution and pharmacovigilance during COVID-19.  The Agency will replace ‘non-essential’ on-site inspections with remote regulatory supervision approaches, such as office-based assessments and information-exchange with … Continue Reading

EMA Publishes Guidance on Clinical Trial Conduct During COVID-19 Pandemic

On 20 March 2020, the European Medicines Agency (EMA) published Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic (the Guidance).  The EMA jointly developed the Guidance with working groups from the European Commission and the national Heads of Medicines Agency (HMA). The Guidance provides information on changes and protocol deviations that … Continue Reading

MHRA issues specification for a “Rapidly Manufactured Ventilator System” for use in hospitals during the COVID-19 outbreak

The Medicines and Healthcare products Regulatory Agency (“MHRA”) has published a specification for a “Rapidly Manufactured Ventilator System” (“RMVS”), setting out the clinical requirements for a ‘minimally acceptable’ ventilator for use in hospitals during the COVID-19 outbreak (the “RMVS Specification”).  The purpose of the RMVS Specification is to meet the UK healthcare system’s increased demand … Continue Reading

DEFRA announces raft of new measures to support food supply and key workers in response to COVID-19

On 20 March 2020, the Department for Environment, Food and Rural Affairs (“DEFRA”) has announced a raft of measures relating to food supply and key workers with the easing the impact of COVID-19 for UK retailers and workers. The Department of Education and Cabinet Office has published guidance on key workers for COVID-19.  The guidance … Continue Reading

The EU Lifts Restrictions to Imports of Poultry Meat from Ukraine Following the Regionalization of the Country Due to an Outbreak of HPAI

The European Commission has just adopted a Regulation that will lift the existing ban on imports of poultry meat from Ukraine that was triggered by the January 2020 Highly Pathogenic Avian Influenza (“HPAI”) outbreak in the western part of the country. On January 19, 2020 the Ukrainian authorities informed the World Organization of Animal Health … Continue Reading

UK sets deadline for novel food authorisation of CBD products

The UK Food Standards Agency has announced a deadline of 31 March 2021 for companies marketing cannabidiol (CBD) extracts as foods or food supplements industry to submit novel food authorisation applications.  After 31 March 2021, the FSA stated that only products with a fully validated novel food authorisation application will be permitted and all other … Continue Reading

The CJEU clarifies the test to determine when a general, non-specific health claim is “accompanied” by a specific health claim

Article 10(3) of Regulation 1924/2006 on nutrition and health claims made on foods (the “NHC Regulation”) permits references to general, non-specific benefits of the nutrient or food for overall good health or health-related well-being, if such a claim is “accompanied” by a specific health claim included in the Union lists. In Case C-524/18, Dr. Willmar … Continue Reading

NHS England Publishes Draft Commercial Framework for Medicines

NHS England has recently published draft proposals on how it plans to approach doing commercial deals with pharmaceutical companies for branded medicines. This draft “Commercial Framework” is now open for comment and consultation (stakeholders can submit their views here). The consultation period ends on 10 January 2020, with Commercial Framework expected to be finalized later … Continue Reading

Clinical Trial Data Are Presumptively Confidential, Opines EU Advocate General

In a long-running legal case challenging the European Medicines Agency’s approach to disclosure of clinical trial data, Advocate General Hogan has recommended that the Court of Justice find that such data are presumptively confidential when handling disclosure requests under the Transparency Regulation 1049/2001. PTC Therapeutics International Limited (“PTC”) had argued before the General Court that … Continue Reading

Regulatory Watch: How has recent Law No 2019-774 of 24 July 2019 on the organization and transformation of the health system changed the anti-gift rules?

French “anti-gift” rules strictly regulate the relationship between the life sciences industry and healthcare professionals (“HCP”) and the possibility for companies active in the health sector to offer benefits, in cash or in kind to healthcare professionals, medical students or associations representing them.  This includes a general prohibition against offering such benefits. To strengthen the … Continue Reading

French medicines regulator produces first in Europe medical devices cybersecurity guidelines

France’s medicines regulator, the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), has released draft guidelines, currently subject to a public consultation, setting out recommendations for manufacturers designed to help prevent cybersecurity attacks to medical devices. Notably, the draft guidelines are the first instance of recommendations released by a national regulator … Continue Reading

UK regulator provides further ‘no deal’ Brexit guidance for medical devices regulation

On 26 February, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) published further guidance (available here) setting out the anticipated regulation of medical devices in the UK, should the UK leave the EU without a deal (Guidance).  This Guidance will apply from ‘exit day’ (expected to be 11 p.m. 29 March 2019) subject to … Continue Reading

European Commission publishes Letter on Exemption allowing for UK Batch Testing post-Brexit

On 21 February 2019, the European Commission wrote to the European Medicines Agency (“EMA”) and the Heads of Medicines Agencies of the EU-27 Member States concerning the acceptability of UK batch testing after Brexit (see the letter here).  The letter seeks to address concerns that a number of pharmaceutical companies will not have been able … Continue Reading
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