Giuliana Miglierini, Autore a NCF International

The European Council redefined the deadlines for certification of medical devices

Medical Device

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13 April 2023

The European Council redefined the deadlines for certification of medical devices

The European Council adopted on 7 March 2023 the regulation extending the deadline for the certification of medical devices. The transition period will now close on 31 December 2027 for higher risk devices and on 31 December 2028 for medium and lower risk devices. The new regulation reflects the need to avoid the risk many medical devices would had not be certified in time with the initial cut-off date, and would had thus become unavailable on the European market. The extension of the transition period will be granted only to devices that are safe and for which manufacturers have already started the certification procedure.

The regulation also removed the “sell-off” date rule, thus preventing the risk of medical devices shortages due to the removal from the market of devices that have not already reached their the final users. The entry into force of the new provisions is the publication date of the regulation in the Official Journal of the EU.

The approval by the Council has been welcomed by EU Commissioner for Health and Food Safety, Stella Kyriakides: “I would like to express my gratitude to the European Parliament, the Council, and the Swedish Presidency in particular for swiftly agreeing on our proposal to extend the transitional periods of the Medical Devices Regulation. This is an important step that will help address the short-term difficulties Member States are facing and ensure a continued access to needed medical devices for patients in the EU. This revised timeline will provide more flexibility to industry for the ongoing certification of needed medical devices and reduce short-term risks of shortages. This will ensure access for patients most in need without jeopardising their safety”.

Source: European Council, European Commission

Towards an harmonised approach of the assessment of exposure to residues of veterinary medicines

European Union

Giuliana Miglierini

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6 April 2023

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Towards an harmonised approach of the assessment of exposure to residues of veterinary medicines

The way exposure to residues of veterinary medicines, feed additives and pesticides in food of animal origin is currently assessed greatly varies depending on the specific piece of legislation and authority involved. To better harmonise methodologies and practices, a joint report has been published by EMA and the European Food Safety Authority (EFSA), answering the mandate received in 2020 by the EU Commission.

Legally binding maximum residue limits (MRLs) of veterinary medicines, feed additives and pesticides are established in the EU according to the different sectorial legislations, on the basis of evaluations carried out by EFSA and EMA, or other relevant authorities. Many different approaches and methodologies are currently used, which may lead to different outcomes.

The joint working group established by EMA and EFSA developed a set of recommendations for each element of the exposure assessment, which were subject to a public consultation in 2022. Comments have been considered in drafting of the final version, which was adopted by EMA’s Committee for Veterinary Medicinal Products (CVMP), endorsed by EFSA’s Scientific Committee, and forwarded to the European Commission in December 2022. Would it adopt the recommendations, their implementation in the different sectors will require a number of follow-up actions over the coming years.

Source: https://www.ema.europa.eu/documents/report/ema/efsa-report-development-harmonised-approach-human-dietary-exposure_en.pdf

The closing report of the EMA and European Commission (EC) action plan on paediatrics

Regulatory

Giuliana Miglierini

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30 March 2023

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The closing report of the EMA and European Commission (EC) action plan on paediatrics

A strengthened focus on unmet medical needs, regulatory processes more suited to support innovation and an increased alignment of data requirements between decision-makers are among the top priorities addressed in the past four years by European regulators in order to increase the efficiency of paediatric regulatory processes. The so obtained achievements are reported in the closing report of the EMA and European Commission (EC) action plan on paediatrics, available at EMA’s website.

Areas of particular need for paediatric medicines have been jointly identified by the Agency and relevant stakeholder, so to optimise the research agenda. Paediatric tumors and inflammatory bowel disease are among the main topics addressed by multi-stakeholder strategy fora, those results have been taken into account by EMA during discussions on paediatric investigation plans (PIPs).

Simplification and adaptation of regulatory processes also occurred to facilitate the establishment of PIPs. The pilot phase for a ‘stepwise PIP’ agreement, for example, is focused in assessing the possibility to agree, in certain cases, on a partial development programme, conditional on the development of a full PIP once evidence becomes available over time. Collaboration with international partners has also been strengthened in order to facilitate the compatibility of paediatric requirements across different regulatory geographic areas.

Source: https://www.ema.europa.eu/documents/report/boosting-development-medicines-children-closing-report-european-medicines-agency-european-commission_en.pdf

MRA agreement signed between the US and the Swiss Confederation

GMP

Giuliana Miglierini

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23 March 2023

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MRA agreement signed between the US and the Swiss Confederation

The mutual recognition of GMPs inspections fo pharmaceutical manufacturing facilities between the US and the Swiss Confederation has been established by the signature on 12 January 2023 of a Mutual Recognition Agreement (MRA). The new agreement will allow the two regulatory agencies, the FDA for the US and Swissmedic for Switzerland, to reciprocally use each other’s results of GMP inspections, thus avoiding the need duplicate activities. The agreement – that includes both human and veterinary medicines – is based on the Food and Drug Administration Safety and Innovation Act of 2012, according to which the FDA may enter into agreements to recognise drug inspections conducted by foreign regulatory authorities determined to be capable of conducting inspections that meet US requirements. The entry into force of the MRA shall be preceded by the mutual determination of the capacity of the respective regulatory agencies to conduct inspections that meet each other’s requirements. The FDA already has MRAs in place with the EU and UK, while Switzerland has signed MRA agreements with the EU, Canada and EFTA.

Source:
https://www.fda.gov/media/164511/download
https://www.swissmedic.ch/swissmedic/en/home/about-us/international-collaboration/bilateral-collaboration-with-partner-authorities/mutual-recognition-agreements.html

The recommendations of the CoE on the equitable access to medicinal products and medical equipment during shortages

Politics & Business

Giuliana Miglierini

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16 March 2023

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The recommendations of the CoE on the equitable access to medicinal products and medical equipment during shortages

The new Recommendation CM/Rec(2023)1 was approved on 1 February 2023 by the Committee of Ministers at the Council of Europe to promote access to medicinal products and medical equipment in a situation of shortage. The Recommendation, that is completed by an Explanatory Memorandum to member states, has been drafted under the responsibility of the Secretary General of the Council of Europe, on the basis of the discussions held in the Steering Committee for Human Rights in the fields of Biomedicine and Health (CDBIO) and in its predecessor, the Committee on Bioethics (DH-BIO), as well as the remarks and proposals made by delegations.

The Recommendation is a consequence of the experience gained during the Covid-19 pandemic, when shortages of many medicinal products and medical devices occurred. It aims to establish a common base of procedural principles to safeguard during shortages the fundamental rights of individuals who need medical treatments for serious or life-threatening health conditions.The Recommendation focuses, among others, on the absence of discrimination, the prioritisation based on medical criteria and the compliance with the principles of accountability, transparency and inclusiveness. It also recommends a system to be in place to prevent and mitigate situations of shortage and to better prepare for such shortages.

Source:
https://www.coe.int/en/web/portal/-/equitable-access-to-medicinal-products-and-medical-equipment-in-a-situation-of-shortage-new-recommendation

https://search.coe.int/cm/Pages/result_details.aspx?Reference=CM/Rec(2023)1

https://search.coe.int/cm/Pages/result_details.aspx?ObjectID=0900001680a97110

MHRA, approval via the ECDRP route will continue for all 2023

Regulatory

Giuliana Miglierini

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9 March 2023

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MHRA, approval via the ECDRP route will continue for all 2023

The UK’s regulatory agency MHRA has announced the possibility to continue submissions for MHRA approval via the current European Commission Decision Reliance Procedure (ECDRP) route for EMA’s applications which will receive a CHMP positive opinion before 31 December 2023. A new streamlined international recognition framework is expected to be launched by the MHRA on 1 January 2024. The new framework should refer to decisions already made by the EMA, as well as other international regulators to be announced by UK’s authorities. Products receiving a CHMP positive opinion after 31 December 2023 will be eligible to enter the new framework. Applications through the decentralised and mutual recognition reliance procedure (MRDCRP) will still be possible after 31 December 2023.

MHRA’s initiative aims to increase routes available to companies to market medicinal products in the UK. A detailed guidance about the new framework has been announced to be published, including any transition arrangements for applications received under existing frameworks. The ECDRP was introduced post-Brexit to facilitate the granting of marketing authorisations in Great Britain on the basis of a European similar decision. In such instances, the assessment of the dossier by the MHRA may be lighter and faster, thus reducing the risk of companies deprioritising Great Britain as a market.

Source: https://www.gov.uk/government/news/european-commission-decision-reliance-procedure-ecdrp-extension
https://www.abpi.org.uk/media/news/2023/january/abpi-response-to-mhra-european-commission-decision-reliance-procedure-ecdrp-announcement/

International associations comment the WHO’s proposal on substandard and falsified medical products

Legislation

Giuliana Miglierini

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1 March 2023

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International associations comment the WHO’s proposal on substandard and falsified medical products

As a part of the ongoing debate at the WHO on the Member State mechanism on substandard and falsified medical products, a statement has been jointly released by the International Pharmaceutical Students’ Federation (IPSF), the International Alliance of Patients’ Organizations (IAPO), and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) to comment WHO’s Director General report on the tenth and eleventh meetings of the Mechanism.

The new draft list of prioritised activities for the period 2022–2023 detailed in the WHO’s document focuses, among others, on the need to strengthen the capacity of national/regional regulatory authorities for handling issues related to substandard and falsified medical products, at the prevention and detection as well as at the response level.

According to IPSF, IAPO and IFPMA, this may offer “an unprecedented opportunity” to the African Medicines Agency (AMA). The recently created regulatory agency faces the challenge to build a strong, unified, and coordinated regulatory system for the African continent, a tool that would greatly contribute to combating falsified and substandard medicinal products by means of enhanced market surveillance, centralised information collection, and sharing of data between countries. The WHO estimates that 42% of all fake medicines reported to the WHO from 2013 to 2017 came from Africa.

Source:
https://ifpma.org/wp-content/uploads/2023/02/EB152_Substandard-and-falsified-products_010223_IFPMA.pdf
https://apps.who.int/gb/ebwha/pdf_files/EB152/B152_7-en.pdf

IFPMA annual survey on research-based pharmaceutical industry reputation

R&D

Giuliana Miglierini

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22 February 2023

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IFPMA annual survey on research-based pharmaceutical industry reputation

The research-based pharmaceutical industry has gained a positive trend in reputation, as a result of its efforts to fight the Covid-19 pandemic, indicates the Ipsos survey commissioned by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). The survey was run in 11 countries and involved 11,000 people aged 18+ living in both high and lower-income countries (USA, UK, India, Brazil, Switzerland, France, South Africa, Japan, Belgium, Germany, Italy).

Particularly appreciated (68%) was the role research-based pharmaceutical companies had in advancing new technologies, i.e more effective medicines or vaccines to tackle the pandemic, as well as possible future public health crises (67%). An high part of respondents (62%) also agreed that research-based pharmaceutical companies are doing all they can to develop solutions to tackle Covid-19. The high level of investments to discover innovative treatments or cures was acknowledged by 62% of respondents. The same percentage indicated research-based pharmaceutical companies are more effective than governments at discovering new medicines and vaccines.

The survey also indicates a positive perception of the contribution biopharmaceutical companies make to society (60%) and to improving health globally (63%).

Source: https://www.ipsos.com/en-uk/improvement-seen-research-based-pharma-industry-reputation

The European Council adopted the new Innovation Agenda and conclusions on research infrastructures

R&D

Giuliana Miglierini

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16 February 2023

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The European Council adopted the new Innovation Agenda and conclusions on research infrastructures

During its December 2022 meeting, the European Council adopted the conclusions on the new European Innovation Agenda and research infrastructures. As said by Vladimír Balaš, Czech Minister for Education, Youth and Sport, “The recent crises have shown the need for the EU to support an open strategic autonomy in order to curb the dependencies and vulnerabilities that affect our industry. We have to strengthen the EU’s own capacity in strategic areas. This will not be possible without ambitious investments in innovation”.

The green and digital objectives remain the main drivers of the new innovation agenda, as they play an essential role in addressing current societal challenges and in positioning the EU as a global leader in innovation. But there are many challenges as a consequence of the geo-political context. Deep tech innovation, new financial models for funding programmes and initiatives, and the attractiveness for new institutional investors are just some key area of intervention set forth by the Agenda. Measures to improve the regulatory innovation environment are also envisaged, including a call to develop a common policy agenda to advance the coordination of innovation policies.

The network of European research infrastructures is an important feature supporting the development of the European Research Area (ERA). The Council’s conclusion supports a further strengthening of the network as a way to better conduct research and foster innovation. RI’s facilities include computer systems, archives or scientific data infrastructures, and sets of instruments, which should be easily accessible to scientists and innovators in order to boost technological advancement and breakthrough innovations. Improved preparedness and the resilience of European society to EU’s socioeconomic crises, a better support to regional development and the contribution provided to scientific diplomacy and international cooperation are also considered. The Council also invited the Commission and the member states to publish the new edition of the European Strategy Forum on Research Infrastructures (ESFRI) Roadmap before the end of 2025.

Source:
https://data.consilium.europa.eu/doc/document/ST-14705-2022-INIT/en/pdf https://data.consilium.europa.eu/doc/document/ST-13921-2022-INIT/en/pdf

The CTIS has fully entered into force

Giuliana Miglierini

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8 February 2023

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A new step toward the full implementation of the Clinical Trials Regulation (CTR) just occurred: on 31 January 2023 the Clinical Trial Information System (CTIS) became the mandatory entry point for all activities linked to the submission and assessment of clinical trials. The system can be access at the link https://euclinicaltrials.eu Since that date, is thus not possible anymore for sponsors to submit an initial clinical trial application according to the previous Clinical Trials Directive. The CTIS is characterised by different dedicated workspaces for sponsors, regulators and patients. The sponsors’ workspace supports application for authorisation of a clinical trial in up to 30 European Economic Area (EEA) countries. Sponsors can also use the system to interact with national regulators during the trial and for recording its results.

The workspace for regulators allows national competent authorities and ethics committees to collaborate to run all needed activities along the entire life cycle of a clinical trial, including assessment, authorisation or oversight. The public section includes the searchable database of individual clinical trials granted or refused permission in the EU and EEA since the launch of the CTIS, on 31 January 2022. The information contained in the database is still limited, and it will gradually grow as sponsors and EU/EEA regulators will use the system to initiate and oversee clinical trials in the EU/EEA. The European Union Clinical Trials Register still remains the source of information on individual clinical trials initiated before 31 January 2022.

Giuliana Miglierini

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