Overview of guidance and information published by the EMA and the FDA concerning the current COVID-19 epidemy
Temporary authorizations issued in response to the COVID-19 pandemic
To help facilitate the availability of infusion pumps, the FDA does not intend to object to limited modifications to the indications, functionality, hardware, software, design, or materials of FDA-cleared devices used to support patients who require continuous infusion therapy, without prior submission of premarket notification.
FDA guidance issued on April 5, 2020.
To help ensure the availability of equipment, the FDA does not intend to object to the distribution and use of clinical electronic thermometers that are not currently 510(k) cleared without compliance with regulatory requirements where such devices do not create an undue risk in light of the public health emergency.
FDA guidance issued on April 4, 2020.
Suppliers of human drugs compounds must be elected to register as an outsourcing facility and must pay certain fees. The guidance describes the types and amounts of fees that outsourcing facilities must pay.
FDA guidance issued on April 3, 2020
This guidance was issued to provide temporary flexibility regarding certain packaging and labeling requirements for shell eggs sold in retail food establishments due to the increasing demand.
FDA policy issued on April 3, 2020
The FDA issued two guidelines on enforcement policy for personal protective equipment during COVID-19. These guidelines allow expanding the availability of general-use face masks for the general public, particulate-filtering facepiece respirators and surgical apparel for health care professionals.
FDA Announcement issued on April 6, 2020.
There is a dramatic reduction in blood donations due to the implementation of social distancing and the cancellation of blood drives. Certain donor eligibility criteria can be modified without compromising the safety of blood supply. Some recommendations, related to virus transmission, transfusion-transmitted Malaria and Creutzfeldt-Jakob disease by blood were revised without compromising the safety of blood donation.
FDA Announcement issued on April 2, 2020.
The FDA issued an Emergency Use Authorization in order to allow the use of certain ventilators, anesthesia gas machines modified for use as ventilators, and positive pressure breathing devices modified for use as ventilators (collectively referred to as “ventilators”), ventilator tubing connectors, and ventilator accessories that the FDA determines to meet specified criteria for safety, performance, and labeling. Eligible devices are those that are not marketed in the US or that are currently marketed in the US but a modification is made to the device that would trigger the requirement that a manufacturer submit a new premarket notification to the FDA.
FDA Announcement issued on March 27, 2020
Some emergency use authorizations have been issued for national-wide use of applications to make tests detecting the COVID-19. More than 160 test developers said they will apply for COVID-19 detection tests.
FDA Announcement issued on March 23, 2020.
The FDA wants to increase the production of ventilators and crucial medical products during the pandemic. Indeed, medical device makers can more easily make changes to the product such as the supplier or materials changes. For that other manufacturers, not previously engaged in medical device manufacturing with the interest and capability to manufacture ventilatory support devices, can repurpose their production lines to increase the supply of ventilators. FDA is being flexible in not enforcing the premarket review requirement for these kinds of changes.
FDA Guidance issued on March 22, 2020.
The Cepheid Xpert Xpress SARS-CoV-2 test will able to provide results within hours rather than days like existing tests. The company plans to roll it out by March 30. It will be a point of care testing, meaning that results will be delivered to patients in the patient care settings (e.g. hospitals, urgent care centers, emergency rooms…) instead to be sent to a laboratory. The FDA issued an authorization to an American diagnostic company (Cepheid) for using their COVID-19 diagnostic test in high and moderate-complexity CLIA(clinical laboratory improvement amendments) certified laboratories and certain patient care settings.
FDA Announcement issued on March 21, 2020.
The FDA allows certain non-invasive, vital sign-measuring devices (e.g. devices measuring body temperature, respiratory rate, heart rate and blood pressure), to be used remotely. During the pandemic, these kinds of devices can be used at home, in order to keep the patient at home and minimize exposure risks to COVID-19.
FDA announcement issued on March 20, 2020.
FDA issues a Temporary policy for production of alcohol-based hand sanitizer
Due to an increased demand for alcohol-based hand sanitizers during the pandemic, the FDA has decided to provide flexibility on production. Two guidance was issued. The first one, Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19), outlines that the FDA will not take action against manufacturing firms preparing alcohol-based hand sanitizers for customer use and health care personnel hand ribs use during the pandemic.
The second one, Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency, applies for compounding of such sanitizers by pharmacists in state-licensed pharmacies or federal facilities and registered outsourcing facilities. The guidance outlines that compounders to not need a patient-prescription to prepare sanitizers.
FDA Guidance issued on March 20, 2020
FDA Identifies critical infrastructure during COVID-19 pandemic
Some infrastructure is essential to be maintained during the pandemic. Please follow the link, defining which infrastructure is critical. Issued on March 19, 2020: DHS Issues Guidance on the Essential Critical Infrastructure Workforce
Measures taken to improve testing, treatment or vaccine of COVID-19
The FDA issues Emergency use authorization to Hologic for its COVID-19 assay and Laboratory Corporation of America for its COVID-19 RT-PCR test.
FDA Announcement issued on March 16, 2020.
The FDA updated a policy originally issued on February 29 about diagnostic testing for coronavirus in order to expand the number and variety of diagnostic tests and testing capabilities in health care settings and laboratories. For that, a policy for states has been put in place. States will take responsibility for test authorization and the laboratories will not engage with the FDA. These laboratories will pursue Emergency Authorization with the FDA.
Secondly, the policy outlined in the Feb.29 guidance will not only apply to laboratories that are certified to perform high-complexity testing consistent with requirements under the clinical laboratory improvement amendments but finally, the FDA also provides a recommendation for test developers who may develop a serological test for use during a pandemic.
FDA Announcement issued on March 16, 2020.
Global regulators have published a report providing an overview of regulatory considerations related to COVID-19 vaccine development and data required for regulatory decision-making. The meeting concluded how regulatory authorities intend to strike the balance between rapid development and generate enough data. This workshop was issued on March 18, 2020, with delegated from 17 different countries. It was co-chaired with EMA and FDA.
EMA Article issued on March 24, 2020.
A call was issued on March 19 by the EMA’s human medicines committee to align on robust trial methodology in COVID-19 clinical trials (vaccine or treatment). They published a statement to prioritize large randomized controlled studies to enable rapid development and approval of COVID-19 potential treatment. They also highlighted the critical need for robust data to determine which investigational or repurposed medicine would be safe and effective for the treatment of COVID-19.
EMA article issued on March 19, 2020.
Measures taken to keep the safety, quality, and availability of drugs and medical devices during the pandemic
This guidance provides specific recommendations as to how these principles may be applied to studies conducted to support new animal drug development during the pandemic.
FDA guidance issued on April 3, 2020.
The FDA prioritizes facilitating access to critical personal protective equipment and devices. They facilitate the entry of needed products into the US by engaging with importers and others involved in the import trade community during the pandemic. Some types of PPE are described in the document instructions to manufacturers, can be imported without engaging the FDA.
FDA Announcement issued on March 24, 2020.
FDA updates on patient access to certain REMS (Risk Evaluation and Mitigation Strategy) drugs
During quarantine and self-isolation, completion of some REMS required laboratory testing or imaging studies may be difficult. For these kinds of drugs, the FDA asks healthcare providers to use their best medical judgment in weighing the benefits and risks of continuing treatment in the absence of laboratory or imaging studies. Healthcare providers should also communicate their judgment to the patient.
FDA Guidance issued on March 22, 2020: Policy for Certain REMS Requirements During the COVID-19 Public Health Emergency Guidance for Industry and Health Care Professionals
The FDA encourages its employees to apply to telework when it is possible. Concerning foreign facility inspections, the FDA decided to postpone these through April and inspection outside the US deemed mission-critical will be considered on case-by-case. They also decided to postpone all domestic routine surveillance facility inspections. However, all domestic for-cause inspection assignments will be evaluated and will proceed if mission-critical. The FDA will continue to leverage all available authorities to continue to ensure the integrity of products.
They will apply different approaches to conduct their inspection work in order not to jeopardize public safety and protecting people, for example evaluating records instead of conducting onsite inspections.
FDA Announcement issued on March 18, 2020.
In response to the global pandemic of COVID-19, the FDA temporarily does not enforce the supplier verification onsite audit requirement for receiving facilities and importers, if other supplier verification methods are used instead. This applies to an onsite audit in defined circumstances (see FDA announcement below). Alternatively, the receiving facility or FSVP importer can temporarily select an alternative verification activity or activities (e.g. reviewing relevant food safety records). Alternative activities must be incorporated in the food safety plan or FSVP.
FDA Announcement issued on March 17, 2020.
EMA’s and FDA’s Guidance for conducting clinical trials
The pandemic may impact the conduct of clinical trials of medical products and require protocol modifications. FDA and EMA outline consideration to assist sponsors in assuring the safety of participants and compliance with good clinical practices.
- Concerning the FDA, trial participants may have no longer access to investigational product or investigational site. Thereby, for assessment, sponsors may evaluate alternative methods, like phone calls or virtual visits and offering safety monitoring for participants. FDA Announcement issued on 18 March 2020: Coronavirus (COVID-19) Update: FDA issues guidance on conducting clinical trials
- On the other hand, the European Medicine Agency (EMA) and the Head of Medicines Agencies (HMA) issued new guidance, which provides recommendations to manage clinical trials during the pandemic. This guidance informed sponsors on changes and protocol deviations that may be needed to continue conducting such clinical trials (participants in quarantine or self-isolation, limitation of access to public places). Recommendations advise sponsors to ensure the utmost safety of trial participants across the European Union whilst preserving data quality and how to share changes with authorities. COVID-19 treatment clinical trials have its specific advice, in particular on the need for large, multinational trial protocol (see the articles on the call issued on March 19 by EMA’s human medicines committee). EMA Guidance issued on March 20, 2020: Guidance to sponsors on how to manage clinical trials during the COVID-19 pandemic
The European Union has organized the first meeting of the EU executive steering group on a shortage of medicines caused by a major event. They discussed measures to address the potential impact of COVID-19 on the supply of medicines in the EU. Because medicines are used to treat COVID-19 patients, patients are requesting more than their usual supplies, shipment problems or other inconveniences related to COVID-19, member states are expecting medicine shortages. To prevent these shortages, healthcare professionals should not provide prescriptions covering more than the usual duration. (link to the national shortages registers and EMA’s shortage catalog)
Pharmaceutical companies are responsible for ensuring the continuity of supply of their product and reporting any shortage to the relevant competent authorities. For that they should put in place measures for the continued supply of their medicines, by, for instance, increasing stocks or finding alternative sources for materials. These companies should also carry out risk assessments. The EMA started a review of manufacturing information on authorized human and veterinary medicines to identify the most risk medicines. These medicines will be a priority for discussions about remedial action with the marketing authorization holder.
To keep informed of the European press release about COVID-19, click here.
EMA article issued on March 10, 2020.
Author: Alix Auter, Life Science Consultant KVALITO
KVALITO is a strategic partner and global quality and compliance services and network for regulated industries. To learn more about our service please visit us on www.kvalito.ch
If you would like to benefit from KVALITO’s expert services, feel free to send us an email to email@example.com.
Are you looking for an exciting and challenging position as a consultant in Europe? Send you complete application to firstname.lastname@example.org
Comments are closed