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.

May 05 COVID-19: EMA accelerates its Regulatory Process

The European Medicines Agency has published an overview of how it will accelerate its regulatory procedures so that the marketing authorisations of safe, effective and high-quality COVID-19 related medicines can be granted as soon as possible. The rapid procedures will be able to accelerate every step of a medicine’s regulatory pathway.

Faster support in the R&D phase

Scientific Advice: In the context of COVID-19, fees for scientific advice are waived and the procedure is reduced to a maximum of 20 days, compared to normally 40-70 days.

PIPs and compliance checks: The total review time for a paediatric investigation plan (PIP) for COVID-19 products will be reduced to 20 days, compared to normally up to 120 days active review time. In case needed, EMA also carries out a check to ensure companies comply with the agreed measures listed in each PIP before a marketing authorisation can be submitted, which will now also be reduced to 4 days.

EUCOPE welcomes these changes intending to fast-track the development and approval of medicines and vaccines.

Apr 28 ECDC – Q&A on COVID-19

The European Centre for Disease Control (ECDC) published an interesting list of questions and answers in relation to the COVID-19 pandemic. The Q&A list, available on their website covers many topics from general information, medical information, prevention, to more practical implications concerning the need for travel, the link between the diseases and animals, etc.

In an exchange of letters with the ECDC, EUCOPE flagged to the agency the importance of Member States guidelines on the treatment of vulnerable patients during COVID-19. EUCOPE is happy to see a list of such national guidelines now featured in the Q&A webpage, under the medical information chapter. This only underlines the need for collaboration between all stakeholders and the paramount importance of a coordinated approach when it comes to fighting this unprecedented pandemic.

The document is accessible here.

Apr 28 EMA Q&A Document on Regulatory Flexibility: Updates on GMP/GDP

The European Commission, EMA and the national competent authorities have agreed on a series of measures to mitigate the impact of disruptions caused by COVID-19 on the conduct of inspections of manufacturing facilities or other sites relevant for medicinal products in the European Union. The measures are detailed in the latest version of the Q&A document.

We want to raise your attention to the following decision: the validity of GMP certificates and time-limited manufacturing and import authorisations, as well as the validity of GDP certificates and time-limited wholesale authorisations will be extended until the end of 2021.

More information is available on the EMA’s website: https://www.ema.europa.eu/en/news/update-guidance-regulatory-expectations-context-covid-19-pandemic

Apr 21 SME Connect Webinar: Role of SMEs in fighting COVID-19

EUCOPE has been invited to speak at the next webinar organised by SME Connect, to discuss the needs of and important role played by small and medium-sized companies in the fight against COVID-19. EUCOPE will be represented by Alexander Natz, EUCOPE Secretary General.

Other panellists include Christian Ehler, MEP and representatives from other trade associations in Brussels. The webinar will take place on 28 April from 9 to 10am.

More info and register here: https://zoom.us/webinar/register/WN_aB0DjXo7Smqeq9-stU8mCQ

Apr 14 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.

Apr 08 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 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 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

Apr 08 COVID-19: 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.

 

Apr 03 COVID-19: 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.

Mar 26 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).

 

Mar 19 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 put in place by some EU Member States to the European Commission, the European Medicines Agency, and national competent authorities.

For further information, please contact Dr Oliver Sude or Laurent Louette at office@eucope.org