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Alliance for Regenerative Medicine

ARM

The Alliance for Regenerative Medicine is an international advocacy organization dedicated to advanced therapy medicinal products.

Lobbying Activity

Meeting with Ekaterina Zaharieva (Commissioner) and

26 Nov 2025 · Life sciences

Meeting with Vilija Sysaite (Cabinet of Executive Vice-President Stéphane Séjourné)

8 Jul 2025 · Biotech

Regenerative medicine alliance urges EU to fund advanced therapies

10 Jun 2025
Topic — The EU Biotech Act seeks to streamline the transition of biotechnology products to market.
Message — The group requests EU-level funding for early development and the creation of regional manufacturing hubs. They also seek more flexible regulatory pathways and reimbursement rules for specialized medical treatments.123
Why — Streamlined regulations and new funding would lower development costs and accelerate commercial entry.45
Impact — Public health payers may face increased financial pressure to fund therapies with uncertain data.6
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Meeting with Olivér Várhelyi (Commissioner) and

10 Jun 2025 · Preparation for the upcoming Biotech Act

Meeting with Jessica Polfjärd (Member of the European Parliament)

6 Jun 2025 · Health Policy

Regenerative medicine group urges EU to lead in advanced therapies

17 Apr 2025
Topic — The consultation seeks a new strategy to restore European competitiveness in life sciences.
Message — ARM calls for aligned industrial and health policies to support advanced therapies. They advocate for streamlining clinical trial rules to speed up patient access.12
Why — The sector would benefit from a more predictable market and increased investment.3
Impact — Global competitors will lose market share if Europe regains its lead.4
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Response to Health technology assessment – Joint scientific consultations on medicinal products for human use

28 Oct 2024

The Alliance for Regenerative Medicine (ARM) welcomes the opportunity to comment on the draft Implementing Act on JSC. The JSC is of critical importance for the successful implementation of JCA. As stated in Article 16 of the HTA Regulation, [the JSC] shall facilitate the generation of evidence that meets the likely evidence requirements of a subsequent JCA on that health technology. This is especially important in the case of medicines at the cutting edge of innovation, such as ATMPs, which face specific evidence generation challenges. The importance of JSCs is corroborated by the fact that the JCA Implementing Act does not foresee the possibility of JCA scoping meetings, except in exceptional circumstances. This makes it even more crucial for HTDs to have the possibility of holding interactions with the HTA CG at an early stage via JSCs. ARM asks that a sufficient - and significantly higher compared to the 2025 Work Plan - level of resources and capacity be made available for JSC so that all demands can be satisfied. Failing to do so would have negative implications for the conduct of JCAs, as a lack of discussion on evidentiary requirements at an early stage, could translate in greater uncertainty at JCA stage. This is particularly the case for ATMPs and OMPs which are often authorised with pivotal single arm trials (SATs) for ethical and practical reasons. The possibility to discuss clinical study design aspects and how the evidentiary gap could be filled when SATs are necessary during the JSC is indeed a pre-condition for a smooth JCA later on. ARM calls for the Recitals of the Implementing Act to make it more explicit the link between JSC and JCA and the importance of the JSC for the successful implementation of HTA Regulation. Furthermore, ARM has the following additional recommendations: 1) JSC request periods should be expanded and ideally requests should be allowed on a rolling basis to reflect the dynamics of clinical development programmes and to ensure alignment with regulatory scientific advice (this is critical in case of parallel EMA SA/JSC). 2) Clarity should be provided on the timelines of the JSC process, so that HTDs can have visibility for planning purpose. 3) In case of parallel EMA SA/HTA JSC, linkages should be established between the JSC outcomes document and the EMA advice. This is necessary to ensure that the joint process ensures alignment. 4) Considering the commercially sensitive nature of information shared by HTDs for JSC ensure the security and confidentiality of the IT Platform.
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Meeting with Stine Bosse (Member of the European Parliament, Committee chair)

19 Sept 2024 · European health policy

Meeting with Michael Kauch (Member of the European Parliament)

30 May 2024 · General exchange

ARM urges flexible EU assessment rules for advanced therapies

2 Apr 2024
Topic — EU rules for the joint clinical assessment of new medicinal products.
Message — ARM urges the inclusion of real-world evidence and observational studies in clinical assessments. They request early scoping meetings and more time for companies to submit dossiers.123
Why — This would lower compliance barriers for biotechnology companies developing advanced therapies.45
Impact — Patients with rare diseases face significant delays in accessing transformative treatments.67
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Meeting with Tiemo Wölken (Member of the European Parliament, Rapporteur)

8 Nov 2023 · Pharma-Revision (staff level)

Regenerative medicine alliance seeks tailored rules for advanced therapies

7 Nov 2023
Topic — Revision of the European Union's general pharmaceutical legal framework and rules for innovative medicinal products.
Message — The group requests harmonized hospital exemptions and a dedicated expert working party at the EMA. They also want advanced therapies exempted from mandatory market launch timelines.123
Why — These changes would protect market exclusivity and reduce regulatory hurdles for gene therapy developers.4
Impact — Hospital-based developers would face stricter limits on producing alternative treatments without a central marketing authorization.5
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Meeting with Pernille Weiss-Ehler (Member of the European Parliament, Rapporteur) and Novo Nordisk A/S

20 Sept 2023 · Directive on Medicinal products for human use

Meeting with Karolina Herbout-Borczak (Cabinet of Commissioner Stella Kyriakides)

19 Sept 2023 · Exchange of views with the Alliance for Regenerative Medicine on the implementation of the HTA Regulation as well as the reform of the EU Pharmaceutical Legislation.

Meeting with Nicolás González Casares (Member of the European Parliament, Shadow rapporteur)

21 Feb 2023 · SoHO

Meeting with Nathalie Colin-Oesterlé (Member of the European Parliament, Rapporteur) and International Plasma and Fractionation Association

24 Nov 2022 · SoHO regulation

Response to Revision of the Union legislation on blood, tissues and cells

8 Sept 2022

The Alliance for Regenerative Medicine (ARM) welcomes the European Commission’s efforts to update and harmonise the standards of quality and safety for substances of human origin (SoHO) and the choice of a Regulation as the legal instrument for this. The proposed Regulation is of great relevance to ATMP developers because SoHO are most often used as starting materials for ATMPs. ARM welcomes greater harmonisation of standards and technical rules for SoHO at the EU level as this supports the development of ATMPs and accelerates patient access. ARM therefore supports general safety and quality principles established at the EU level that are uniformly defined, applied, and controlled across the EU. ARM strongly supports the decision to maintain the existing delineation between SoHO/BTC and ATMP in the proposed Regulation. We are however concerned with the reference in point 1 of the Explanatory Memorandum to the revision of the general pharmaceutical legislation and the possibility that the BTC/ATMP delineation criteria could be changed as part of that work. We call on the European Commission to maintain the existing definition/criteria of when cells and tissues shall be considered “engineered” and thus fall under the scope of the pharmaceutical/ATMP legislation. These provisions, based on whether human cells/tissues are subject to substantial manipulation or are intended to be used for a different essential function (non-homologous use), provide a stable, yet flexible regulatory framework which is essential to facilitate innovation and is fit for purpose to address evolving science and as such should be maintained. Changes to these classification criteria would impact global convergence of ATMP regulations and hamper the competitiveness of the ATMP sector in the EU. ARM welcomes the efforts to put in place a mechanism to advise on classification of borderline products at the EU level. ARM believes however that there is a lack of clarity on the process proposed and how the different bodies involved would interact. The role of the European Commission in the process and whether or not its decisions would be mandatory is unclear. Above all, ARM calls for EMA CAT to be given a central role in any discussion and decision pertaining to borderline cases between SoHO and ATMP. This will reduce the risk of divergent interpretations between classification bodies on whether a product falls under one legislative framework versus another and at what point in the production process standards from each framework are applied. ARM asks for Recital 9, which refers to GMO legislation, to be removed, as any BTC, at the point of becoming GMO (i.e. genetic manipulation) is no longer a SoHO within the scope of the proposed regulation, but instead part of the manufacturing process of an ATMP and the entity carrying out such manipulation would be either an ATMP manufacturer or part of the ATMP manufacturing process. Article 2.3 specifies that the Regulation applies “insofar as the activities for SoHO release, distribution, import and export relate to SoHOs prior to their distribution to an operator regulated by the other Union legislation.” The effect of this article on Articles 42-44 regarding requirements for importing SoHO entities is unclear for a manufacturer importing SoHO material for production of ATMPs. While importers of plasma intended for manufacture of medicinal products and included in a plasma master file are explicitly excluded, manufacturers of ATMPs are not. Such imports would already be covered under medicinal product GMPs and should be clearly excluded from Article 42 and related articles to avoid a double burden. Furthermore, Article 2.3 should include a reference to the Clinical Trials Regulation 536/2014 to ensure any SoHOs used to manufacture investigational ATMPs are also covered.
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Meeting with Karolina Herbout-Borczak (Cabinet of Commissioner Stella Kyriakides)

27 Jan 2022 · Exchanges of views on policy priorities of the Alliance for Regenerative Medicine in Europe: the Pharmaceutical Strategy and the EU’s Beating Cancer Plan

Response to Evaluation of patient rights in cross-border healthcare

11 Feb 2021

The Alliance for Regenerative Medicine (ARM, www.alliancerm.org) is the leading international advocacy organisation dedicated to realizing the promise of advanced therapy medicinal products (ATMPs). In its 11-year history, ARM has become the global voice of the sector, representing the interests of 370+ members worldwide and 70+ members across 15 European countries, including small and large companies, academic research institutions, major medical centres and patient groups. ARM very much welcomes the Commission’s initiative of assessing the implementation and impact of the Cross-Border Healthcare Directive (2011/24/EU) and how it interacts with other legislation (in particular Regulation EC 883/2004). While fully supporting the objective of identifying existing gaps in preserving patient rights to cross-border healthcare, ARM calls the EU Commission to assess the potential for improving implementation of existing legislation with the objective of reducing the above-mentioned gaps. ARM would like to highlight the many challenges that ATMP patients are facing in receiving treatment. Due to their technological specificities and the conditions they aim to address, not all approved ATMPs can be made available across all countries in Europe. This often means ATMP treatments for patients are available only in a cross-border setting and in specialized centres. One well-known example is the ATMP Strimvelis (a gene therapy for the treatment of patients affected with severe combined immunodeficiency), that in the EU is authorized to be administered in one clinical centre in Italy. Since its EU marketing authorization in 2016, several patients from across the EU have struggled in accessing this life-saving treatment. Similar challenges are likely to be faced by patients to be treated with ATMPs. Thus, the effective design and implementation of the Cross-Border Healthcare Directive is key for ATMP patients to be ensured to receive necessary medical care in another EU country and to be reimbursed for it. ARM would like to stress the importance of leveraging existing networks of specialized centers for rare diseases and the need for setting up multistakeholder initiatives aimed at improving cross-border access to relevant ATMPs. ARM has published “recommendations on cross-border and regional access to Advanced Therapy Medicinal Products (ATMPs) in Europe”, which you can find attached as an Annex and which describe in more detail the ATMP-related shortcomings of cross-border healthcare legislation and of its implementation at country level. In order to ensure that patients across Europe can access ATMP treatment, ARM recommends: • Creating a one-stop shop coordination body at EU/EEA level, to act as a broker between the different stakeholders and facilitate cross-border patient treatment and funding. • Establishing a one-stop shop in countries with regional funding or with multiple payers/insurers to manage treatments and possibly leveraging National Contact Points, to compensate authorities in the region of treatment for the costs of treating patients from other regions. • Improving opportunities for cross-country collaboration to deliver faster and broader access. Removing duplicative processes at national level and adopting policy principles to enhance cross-country collaboration would facilitate industry engagement in existing initiatives. • Excluding cross-border treatments from claw-back or other pay-back mechanisms that may be in place in the treatment country, as such mechanisms are typically based on pharma expenses/sales in the country for ‘national’ patients. Additional transparency on the number and type of treatment provided for cross-border patients would therefore be warranted. ARM is committed to contribute to the consultation process foreseen by the Commission for this initiative and to bring the perspective of the ATMP sector.
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Response to A European Health Data Space

3 Feb 2021

The Alliance for Regenerative Medicine (ARM, www.alliancerm.org) is the leading international advocacy organisation dedicated to realizing the promise of advanced therapy medicinal products (ATMPs). ARM promotes legislative, regulatory and reimbursement initiatives in Europe and internationally to advance this innovative and transformative sector, which includes cell therapies, gene therapies and tissue-based therapies. In its 11-year history, ARM has become the global voice of the sector, representing the interests of 370+ members worldwide and 70+ members across 15 European countries, including small and large companies, academic research institutions, major medical centres and patient groups. As ATMPs are administered just as one or very few doses and exert a long-lasting, profound, potentially curative effect, the generation of real-world evidence (RWE) is a critical component in the evidence generation and the assessment of ATMPs across their whole lifecycle, from the early phases of their clinical development. Furthermore, a significant number of ATMPs are expected to obtain European marketing authorization in the years to come with 20 to 30 submissions per year expected by EMA from 2025. This will result in an increasingly urgent need to address inefficiencies coming from a fragmented, inconsistent, and often unusable RWE ecosystem in Europe. Due to the often rare or ultra-rare nature of the conditions that they address and to the complexity of supplying such transformative technologies, ATMPs are typically administered in a limited number of centres of expertise. In some cases, patients need to move within the EU to receive treatment in a country that is not their country of residence. In the context of ATMPs, cross-border healthcare and access are at the same time extremely needed and extremely challenging for the EU ecosystem. While the Cross Border Healthcare Directive (23/2011) and the Social Security Regulations (883/2004 and 987/2009) establish the right principles for cross-border access to ATMPs, they give only limited – if any - opportunities to EU citizens to get treated with ATMPs in countries different from their country of residence. In July 2020, ARM made a “call to the European Commission to fast-track RWE for ATMPs” and early in 2020 published a position paper on “ARM recommendations on cross-border and regional access to Advanced Therapy Medicinal Products (ATMPs) in Europe.” ARM believes that both documents are relevant to this consultation process and have been attached as annexes. Overall, ARM is strongly supportive of the ‘A European Health Data Space’ initiative and the proposed new legislation. More specifically: 1) ARM is concerned about the current fragmentation of health data in the EU and believe that it represents a considerable burden to the ATMP stakeholder community. 2) Health data fragmentation comes with a significant lack of health data usability, mainly due to the lack of interoperability through registries and other collection and analysis vehicles. All this largely limits the potential for doing Health Technology Assessment (HTA), for implementing innovative payment models and for realizing the promise of cross border access to ATMPs. 3) Considerable inefficiencies are also due to a proliferation of standards and platforms. These issues are hampering innovation coming from ATMPs and related health innovations, for example in developing and using best-in-class RWE. 4) The European Health Data Space legislation will need to identify solutions for secondary use of health data preserving data protection both under GDPR and national regulations. ARM is committed to contribute to the consultation process foreseen by the Commission for this initiative and to bring the perspective of the ATMP sector.
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Response to Revision of the Union legislation on blood, tissues and cells

14 Dec 2020

The Alliance for Regenerative Medicines (ARM) thanks the European Commission for providing insights on its plan for addressing gaps and shortcomings in the current Blood, Tissues and Cells (BTC) legislation and welcomes the European Commission (EC)'s objectives to ensure safety and quality for patients and to support innovation. In particular, ARM welcomes the Commission’s initiative to provide more clarity on scope of the application of the BTC directives and to create greater transparency and coherence in the classification between BTC, medicinal products, including advanced therapies, and medical devices. We note that the inception impact assessment refers to ‘innovative BTC therapies’, without offering a clear definition of what such therapies cover. Since the requirements for each of these categories are dramatically different, reflecting the potential risks for patients when cells and tissues are manipulated or used in a non-homologous way, it is critically important that clear, transparent, consistent and science-based criteria are used for making the distinction between BTC, ATMPs and medical devices. In the interest of patient safety, it is important that medicinal products and devices based on BTC have their benefit/risk profile clearly established and can only be regulated as medicinal products; BTC legislation must not be exploited to offer medicinal products outside the context of clinical trials, marketing authorisation or, to a limited extent where justified, compassionate use. The creation of distinct classification criteria that apply irrespectively of the manufacturer or country is necessary to ensure high quality healthcare in Europe. The EC proposal to have an EU level mechanism to advise Member States on classification (as described in the 3 proposed policy options) is therefore welcome, provided there is no possibility of divergent interpretations and decisions across Member States and across existing classification bodies (e.g. CAT). In that respect, ARM fully supports the feedback provided by the Committee for Advanced Therapies (CAT) on 11 December 2020. BTC are used as starting materials in the majority of the Advanced Therapy Medicinal Products (ATMPs) currently in development and on the market. However, depending on where in Europe these BTC are sourced and used for onwards manufacturing of ATMPs, regulatory requirements (e.g. donor testing, coding requirements, quality testing, etc) may be very different. The different requirements for Tissue Establishments across the EU is an additional source of complexity. These divergences in interpretations and implementations hamper the cross-border transportation of BTC within the Union and create unnecessary costs and delays as well as administrative burden to ATMP manufacturers. ARM therefore encourages the option to streamline such requirements by establishing general safety and quality principles at EU-level and recommends ensuring that such principles are uniformly defined, applied, updated and controlled across the EU. ARM believes that the best way to achieve a consistent implementation of such principles would be to adopt a EU Regulation covering the essential elements to be uniformly applied across the EU (potentially going beyond policy option 3). Robust, science-based, and harmonized regulatory requirements are essential to ensuring patient safety and keeping high quality ATMPs manufactured and commercialized in Europe. This requires the enforcement of common regulatory standards across Europe, including clarity on the classification of borderline products, independently of the manufacturers and country. As the global voice of the ATMP community, ARM is looking forward to bringing in its members’ expertise to contribute to the consultation process, particularly about the interplay between the different frameworks (BTC, medicinal products and MD) and the policy options to ensure the above-mentioned objectives are best met.
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Response to Pharmaceutical Strategy - Timely patient access to affordable medicines

6 Jul 2020

The Alliance for Regenerative Medicine (ARM) welcomes the opportunity to provide feedback on the roadmap to the EC pharmaceutical strategy. ARM is the leading international advocacy organisation dedicated to realizing the promise of advanced therapy medicinal products (ATMPs) and represents the interests of 350+ members worldwide and 70+ members across 15 European countries, including small and large companies, academic research institutions, major medical centres and patient groups. ATMPs, including cell therapies, gene therapies and tissue engineered products, constitute a new category of innovative products whose full potential is beginning to emerge. The ATMP sector is creating transformative, durable treatments and potential cures for some of humankind’s most devastating diseases – many currently untreatable via conventional treatments – through the use of ground-breaking scientific discoveries and technologies. The Covid-19 crisis revealed the importance of investing in healthcare, particularly in areas of unmet needs. ATMPs can play an important role to meet these needs and represent an opportunity for Europe to take a leading role in embracing this new field of innovation. To ensure patients across Europe have access to safe and effective ATMPs, ARM believes the following priorities should be addressed in the EC pharma strategy: (1) Ensuring that regulatory procedures are robust, transparent, evidence-based and harmonized in Europe • limiting hospital exemption and other regulatory carve outs that threaten patient safety (2) Streamlining regulatory requirements for clinical trials with ATMPs across the different Member States, • ensuring smooth implementation of the upcoming clinical trial regulation • reconsidering the scope and implementation of the GMO legislation to medicinal products. (3) Ensuring patients’ timely access to ATMPs by • launching new initiative to build RWE infrastructure and disease registries at pan-European level. • coordinating ATMP clinical assessment at EU level, while adapting the HTA evaluation, pricing and reimbursement processes to capture and value the long-term benefits and risks of ATMPs, • facilitating cross-border treatment with ATMPs, and • supporting the adoption of innovative pricing and payment models for ATMPs to ensure continued patient access to innovative therapies while preserving the sustainability of health systems in the EU. More background information on the above priorities is provided in the attached document. ARM is committed to engage and bring the ATMP sector’s perspective in an inclusive and solution-driven dialogue with the Commission, Member States and all interested parties to facilitate the development and access to innovative treatment for the patients’ benefit. To learn more about ARM, visit http://www.alliancerm.org. Transparency register number ID: 244710319190-73
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Response to Evaluation of the legislation on medicines for children and rare diseases (medicines for special populations)

7 Jan 2018

The Alliance for Regenerative Medicine (ARM) thanks the European Commission for the opportunity to comment on its evaluation roadmap regarding the regulations on medicines for rare diseases and for paediatric medicines. ARM is a global advocacy organisation that promotes legislative, regulatory, reimbursement, investment, technical and other initiatives to accelerate the development of safe and effective Advanced Therapies Medicinal Products (ATMPs). ARM is a multi-stakeholder organisation, with more than 280 member organisations including - among others - pharmaceutical companies, healthcare investors, academic institutions, scientific societies, service providers and patient organisations with a stake in ATMPs. A large proportion of products developed by our member organisations address unmet medical needs in rare conditions and/or paediatric diseases. The forthcoming evaluation will therefore be highly relevant and could potentially impact many of our members. Generally, ARM believes that maintaining a favourable environment for the research, development and market access of medicines is critically important to ensure continued investments in paediatric and rare diseases in order to bring new solutions to patients with unmet medical needs. Therefore, ARM would like to recommend that an impact analysis to evaluate the potential consequences of any adaptation to the current framework be carried out as part of the evaluation to ensure that (1) the objective to further and better address the unmet medical needs in paediatric patients and/or patients with rare diseases is met and (2) that European competitiveness is reinforced as a region to invest and develop new therapeutic solutions to patients. ARM is interested to better understand what is the scope of the additional study to be launched in 2018 ‘to address the remaining questions especially on orphan medicinal products’. Further details on what these remaining questions are would be appreciated. ARM fully supports the Commission’s intention to take into account global developments, especially in the USA, as indeed companies developing ATMPs have a global focus and welcome international regulatory convergence. In this context, ARM would like to suggest that the FDA, and possibly agencies in other jurisdictions (Canada, Australia…?), be added on the list of data sources for the Commission evaluation. ARM notes that a public consultation as well as a targeted consultation will be carried out during 2018 and would like to express its interest in participating in both.
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Response to Definition of the concept "similar medicinal product"

27 Nov 2017

The Alliance for Regenerative Medicine (ARM) thanks the European Commission for the opportunity to provide feedback on the proposed Commission Regulation amending Regulation (EC) N° 847/2000 as regards the definition of the concept of ‘similar medicinal product’. ARM welcomes the clarification to the recommendations for Advanced Therapy Medicinal Products (ATMPs) which now more clearly differentiate the requirements by types of products, i.e. cell-based ATMPs, gene therapy medicinal products and genetically modified cells. In line with previous comments made during the public consultation in November 2016, ARM believes that the similarity assessment of ATMPs should be multifactorial and not be limited to an assessment based on the starting materials and final composition. principal mode of action, the cell functionality and the biological features of the cell product could influence the efficacy and safety profile of the ATMP and should be mentioned more explicitly as elements to be considered in a multifactorial similarity assessment. It is unclear whether differences that ‘have a significant impact on the biological characteristics and/or activity relevant for the intended therapeutic effect of the product’ will be interpreted as differences in efficacy only (as suggested by this wording, used for all types of ATMPs) or whether differences in safety profile, mode of action or mode of delivery will also be considered as having a potential impact on the product activity and reference to this is not explicitly stated in the Regulation. ARM believes that all these factors are potentially important, could have an influence on the similarity or dissimilarity of products and should be reflected in the amended Regulation. In addition, it would be useful to provide further clarity on how the general principles on the structural features, biological and functional characteristics are likely to be applied, as well as how a significant impact of a difference between two ATMPs can be demonstrated. ARM had previously suggested that COMP and CAT release a “Reflection Paper” (similar to the Reflection Paper on ATMP classification for example) or a “Questions & Answers” document to provide further clarity on how the general principles on the structural features, biological and functional characteristics are likely to be applied. Such paper could also provide guidance as to how dissimilarity between two ATMPs can be demonstrated. Finally, ARM would welcome increased transparency on the justification for similarity/non-similarity assessment for all orphan medicinal products, irrespectively of their nature (ATMPs or not). This would provide greater clarity on the case-by-case evaluation by the EMA. It is therefore requested that the EC (or CHMP/CAT) publishes the elements and criteria justifying its decision on the similarity/non-similarity of any orphan medicinal product shortly before or after approval (e.g. as part of the EPAR) or at least inform the marketing authorization holder of a product with the same orphan therapeutic indication of such evaluation and its conclusion. More information regarding the Alliance for Regenerative Medicine (ARM) can be found at: www.alliancerm.org. ARM Transparency register number ID is: 244710319190-73.
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Meeting with Annika Nowak (Cabinet of Commissioner Vytenis Andriukaitis)

8 Nov 2017 · Advanced therapy medicinal products