COVID-19 Updates

See here a digest of news or articles in relation to the COVID-19 crisis. For further information, please contact us at office@eucope.org.

See here a digest of news or articles in relation to the COVID-19 crisis. For further information, please contact us at office@eucope.org.

Q&A Document on Regulatory Expectations during COVID-19

The European Commission, EMA and the European medicines regulatory network have developed a question and answer guidance document on regulatory expectations for medicinal products for human use during the COVID-19 pandemic. You can access the guidance online here https://www.ema.europa.eu/en/news/guidance-regulatory-requirements-context-covid-19-pandemic.

The Q&A document includes information on legal and regulatory guidance on

  • MAs/MAs procedures;
  • manufacturing and importation of Finish Product and Active pharmaceutical ingredients with an Exceptional Change Management Process (ECMP) being introduced;
  • quality variations;
  • product information and labelling.

This document is a living document which will be updated as required. EUCOPE will report any comments from its member companies at the weekly calls with the EMA and national authorities on the COVID-19 crisis and its impact on the regulatory environment for medicines in Europe.

How is COVID-19 impacting payers and HTA decisions across the EU?

Given the unprecedented global shutdown occurring in response to COVID-19, payers and HTA bodies are struggling to adjust to the new way of working. What impact is this having on existing drugs that are currently undergoing pricing, reimbursement and health technology assessments? How has each country adapted to the challenges?

Our members ReMap Consulting have compiled data from HTA bodies on their decision making for new medicines here.

Should you also experienced some changes in the HTA processes for your drugs since the onset of the pandemic, you can take the very short survey here, to further update the above-mentioned report.

COVID-19: Need for undisrupted access to treatment in hospitals

The COVID-19 pandemic creates an extraordinary situation for all stakeholders. EUCOPE members are particularly concerned with the impact the COVID-19 crisis created on clinical development.

Delay of early patients’ access to innovative treatment

The delay caused by the pandemic in drug development is in particular concerning in the area of investigations on unmet medical need and life-threatening diseases.

If nothing is done, we could see a delay in patients’ access to treatment and therapies in hospitals, which could have a detrimental impact. This aspect will be emerging for companies whose specialized therapies are given to patients in hospitals. With hospitals at full capacity and focusing entirely on battling the Coronavirus, we need to undisrupted access to treatment and therapies in hospitals.

National divergences in clinical trials

EUCOPE notes that there is a level of divergence at EU level concerning the clinical trial guidance, with different level of pragmatism on how clinical trial sponsors can manage the uncertainty and the conduct that some trials are in. We also notice discrepancies in requirements for deviation management, urgent safety measures, and other contingency planning that requires regulatory actions;

EUCOPE asks EU authorities and national agencies to coordinate as much as possible their requirements and to ensure a harmonized, pragmatic approach across EU Member States. This will facilitate how companies, particularly small & medium enterprises, manage multi-country clinical trials and ensure patient safety is assured

EUCOPE Calls for more Regulatory Flexibility

Following the recent EMA guidance on clinical trials management during COVID-19, EUCOPE calls the EMA and all national authorities to allow for flexibility in these exceptional times. In addition, EUCOPE recommends the following:

  • Standardised Approaches:  all stakeholders involved in discussing the COVID-19 response make best efforts to align across Member States as much as possible and to be as pragmatic as possible; European-wide approaches are necessary to ensure there is no increased risk of breaking the integrity of the trial and the data it generates.
  • Regulatory Flexibility: Consistent with the spirit of providing the maximum level of regulatory flexibility in the clinical trial guidance, flexibility in adjusted timelines for satisfying regulatory requirements in relation to clinical trials.
  • Statistical Issues: Inevitably study participants will not be able to attend clinical sites for follow-up visits, leading to missed data points delayed readouts or missing data. This will lead to necessary changes to statistical plans.
  • Global Collaboration and Alignment: Global regulatory authorities should leverage and expand existing regulatory collaboration mechanisms to ensure the safety and rights of participants are not compromised and the integrity of the data from the trial is maintained.
  • Innovative Clinical Trial Strategies: Since participant travel to clinical trial sites will be limited during the COVID-19 crisis, EU regulators should encourage innovative approaches to evaluate new medical products, such as through master protocols, adaptive studies, and decentralized trial designs.
EMA New Guidances on Clinical Trials

The European Medicines Agency (EMA) recently issued a new guidance following the COVID-19 outbreak, to help clinical trials sponsors in adjusting their management of trials and participants during the pandemic.

The guidance covers how to deal with, for example, the self-isolation or quarantine of trial participants, limited access to public places (including hospitals) due to the risk of spreading infections and reallocation of healthcare professionals. It also advises on how to communicate these changes to the national competent authorities.

It provides specific advice on clinical trials for COVID-19 treatments, including the need for large, multi-national trial protocols.

This in line with the CHMP’s call urging the EU research community to prioritise large randomised controlled clinical studies as these are most likely to generate the conclusive evidence needed to enable rapid development and approval of potential COVID-19 treatments.

Commission eyes MDR postponement by one year

The European Commission announced on 25/03/20 that it will work to propose to the postponement of the implementation date of the Medical Devices Regulation (2017/745 – MDR).

In light of the fight against COVID-19 and its numerous consequences on the healthcare systems and all actors, including industry, DG SANTE took the decision to put forward to the Parliament and the Council the proposal to postpone the MDR by one year.

EUCOPE welcomes the proposal as it will give time to small and medium companies to devote their efforts on the fight against #COVID19 and allow for a proper implementation in a year time.

For more information on our work on Medical Devices and In Vitro Diagnostics Devices, please contact Laurent Louette (louette@eucope.org).

COVID-19: Monitoring any Shortages or Distribution Problems

EUCOPE and its member companies are closely monitoring the COVID-19 situation and its potential impact on the manufacturing and distribution of medicinal products. EUCOPE is reporting any expected shortages or distribution problems due to the COVID-19 outbreak and/or current cross-border restrictions to the European Commission, the European Medicines Agency, and national competent authorities.

For further information, please contact Dr Oliver Sude or Laurent Louette.