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1、ICON and regulatory know-how for China biotech in the EU How to navigate European Medicines Agency registration and regulationProcedural and regulatory know-how for China biotech in the EU2ContentsExecutive summaryDefinitionsIntroductionHurdles for China-based biotech companies submitting MAAs to EM
2、AClinical trial and clinical dataAdministrative challenges to China-based biotech companies when entering the EUUnderstanding EMA regulatory processes and the EU centralised procedure for marketing authorisation Early engagement of China-based companies with EU EMA and national regulatory authoritie
3、sEarly and late interactions between the applicant and European Medicines Agency at scientific advice meetingsCase study:China-based biotech applications post-COVID-19ConclusionFurther reading3457 9953Procedural and regulatory know-how for China biotech in the EUExecutive summaryApplicant
4、s must also begin communicating with the EMA during the early development stages of medicinal products to identify the optimal EMA procedure and align with EMA product leads,rapporteur,and co-rapporteur.These interactions are critical to identifying the regulatory strategy for the optimal route to t
5、he approval of medicinal products.It subsequently aids the generation of the correct clinical,non-clinical and quality data during their development and in the marketing authorisation submission planning stage to ensure the best possible chance of a successful validation and subsequent likelihood of
6、 a positive opinion by the Committee for Medicinal Products for Human Use(CHMP).ICON has experience providing regulatory direction and strategy to China-based clients during and after preparation for regulatory submissions in the centralised procedure to the European Medicinal Agency.In this white p
7、aper,ICONs experts outline potential regulatory strategies and interaction plans for sponsors in China as a guide for marketing authorisation applications in the centralised procedure to the EMA,which allows the marketing authorisation holder to market a drug product in all European Union(EU)Member
8、States,in addition,specific countries in European Economic Area(EEA)(Iceland,Norway and Liechtenstein),with a potential patient pool of approximately 500 million people.Drug development requirements in China differ substantially from the EU legislation.Before applying for marketing authorisation,app
9、licants must assess the products eligibility for the centralised procedure,analyse the clinical,non-clinical and quality data package for potential gaps and ensure content is as per the European Medicines Agency(EMA)requirements.Procedural and regulatory know-how for China biotech in the EU4Definiti
10、onsCentralised procedure:the centralised procedure aims to obtain a single centralised marketing authorisation valid in all EU and EEA-EFTA states.This allows the marketing authorisation holder to market the medicine and makes it available to patients and healthcare professionals throughout the EEA.
11、The EMA centralised procedure includes:The scientific assessment of data conducted by a rapporteur/co-rapporteur The Assessment of the risk management plan by the Pharmacovigilance Risk Assessment Committee The Scientific discussion and final scientific opinion carried out by the Committee for Human
12、 Medicinal Products(CHMP)CHMP:The Committee for Medicinal Products for Human Use(CHMP)is the European Medicines Agencys(EMA)committee responsible for human medicines.The CHMP plays a vital role in the authorisation of medicines in the European Union (EU).In the centralised procedure,the CHMP is resp
13、onsible for:Conducting the initial scientific assessment of EU-wide marketing authorisation applications Assessing modifications or extensions(variations)to a marketing authorisation Considering the recommendations of the Agencys Pharmacovigilance Risk Assessment Committee on the safety of medicines
14、 on the market Eligibility for the centralised procedure:All human medicines derived from biotechnology and other high-tech processes must be evaluated by the EMA via the centralised procedure.The same applies to all advanced therapy medicines and medicinal products containing new active substances
15、intended for the treatment of HIV/AIDS,cancer,diabetes,neurodegenerative diseases,autoimmune and other immune dysfunctions,and viral diseases,as well as to all designated orphan medicines intended for the treatment of rare diseases.To find out whether a product can be evaluated under the centralised
16、 procedure,companies should submit to the CHMP an eligibility request.EMA:European Medicines Agency.The European Medicines Agency is responsible for the scientific evaluation of applications for centralised marketing authorisations.5Procedural and regulatory know-how for China biotech in the EUThe C
17、hinese Government appears to have a spotlight on the healthcare industry for its 14th Five Year Plan(FYP),allocating approximately 13.7bn to support brain sciences,genetics,biotechnology,and clinical medicine advancement.China has implemented over 70%of the International Council for Harmonisation of
18、 Technical Requirements for Pharmaceuticals for Human Use(ICH)standards,which will enable the country to participate in multi-region clinical trials and further globalise Chinas pharmaceutical industry.Biopharmaceuticals in China have seen their global commercial and manufacturing footprint almost d
19、ouble between 2019 and 2021,with the number ex-Chinese out-licensing deals growing from 14 to 27.According to the McKinsey Impact of China Biopharma on Global survey,the biggest threat to Chinas biotech trajectory is the regulatory setback caused by geopolitical issues,which would prevent China-orig
20、inated innovation from reaching global patients.To avoid regulatory setbacks,China-based companies must consider that drug development requirements in China differ substantially from the EU legislation as they prepare to perform regulatory submissions in the centralised procedure to the EMA.China-ba
21、sed companies need to prepare for resources,collaboration partners and timelines when planning to perform regulatory submissions in the centralised procedure to the European Medicinal Agency.Differences and similarities in contrast to US FDA and China Health Authority(NMPA)need to be considered(See
22、figure 1).Introduction180 days before submission Letter of Intent(LoI)Assess eligibility for central procedure Pre-submission meeting Appointment rapporteur Application file Establishment of EU office10 days before submission to day 1 of procedure Submit application for market authorisation in the c
23、entralised procedure Validation of application file Start procedureDay 80 Rapporteur and co-rapporteur assessment report Receive comments from CHMP CHMP peer review Preparation of day 120 list of questionsDay 120 CHMP adopts day 120 list of questions List of questions provided to applicant GLP/GCP/G
24、MP inspection requestsEarly preparation phase(LOI/eligibility/resources allocation)to Day 120The FYP also details Chinas ambitions for biopharma hubs in the country;one example is Shanghais goal to make biopharma a 173.9 bn business by 2025.China has a significantly large global innovation pipeline
25、annual growth rate of 38%,compared to the global average of 5%.Procedural and regulatory know-how for China biotech in the EU6 Day 121(Restart)Submission of responses to Day 120 LoQ Restart of procedure (Day 121)Scientific Assessment Rapp.Scientific Assessment Co-Rapp.Pre-opinion phase Day 121 to Da
26、y 210Post-Opinion Phase Day 210 to Day 277Day 150/Day 165 to Day 180 Rapporteur and Co-Rapporteur Joint Assessment report Comments by CHMP members EMA QRD subgroup meeting CHMP discussion meeting CHMP decision for list of outstanding issues(LoOI)or oral explanation meeting GLP/GLP/GMP inspection rep
27、orts to CHMP List of Outstanding Issues (LoOI)adopted by CHMP Oral explanation by applicantDay 181 to Day 210 Response to LoOI or resolution at OE meeting CHMP positive or negative opinionClock Stop(1m)Figure 1-EMA Centralised Procedure Timeline from Early Preparation Phase to EC DecisionDay 210 Fol
28、lowing procedure from Day 210 to Day 277Day 215 Applicant provides EMA with product information in all official EU languages Linguistic review by member states;member states provide commentsDay 232 Applicant provides final translations to EMADay 277 Valid EU Marketing Authorisation EC decision7Proce
29、dural and regulatory know-how for China biotech in the EUHurdles of China-based biotech companies submitting MAAs to EMAChina-based biotech companies follow their local legislation and drug development requirements;however,these requirements differ substantially from EU legislation and requirements.
30、Although China NMPA has initiated revision processes of national drug development requirements,China-based pharmaceutical companies are still facing acceptance issues in other health authorities,including the EMA,regarding CMC,non-clinical and clinical registration data.The China National Medical Pr
31、oducts Administration(NMPA)has been continuing to upgrade pharmaceutical regulatory standards for closer harmonisation with the US and EU regulatory frameworks.China joined the International Council for Harmonisation(ICH)on 1 June 2017,which reinforced the countrys objective to reform and improve Ch
32、inas drug regulatory policy,as well as its resolution to meet the international standards represented by ICH member states.The regulatory upgrade and revision process does significantly affect drug development companies,manufacturers,and suppliers of active pharmaceutical ingredients,excipients,pack
33、aging materials,finished dosage forms,and investigational medicinal products.The regulatory changes in China will increase the probability of acceptance of the marketing authorisation application dossier at the EMA and are therefore considered positive for the pharmaceutical sector in China intendin
34、g to enter the EU or US markets.Examples of non-compliance of non-clinical,clinical and/or CMC/manufacturing data of China-based biotech companies with EU requirements include the following:Non-clinical studies conducted in China,according to China good laboratory practice(GLP),which do not meet the
35、 requirements of the Organisation for Economic Cooperation and Development (OECD)GLP NMPA CMC requirements on active substances/drug substances and drug products differ from EU CMC and GMP requirements Requirements for manufacturing site processes in China differ from EU manufacturing process requir
36、ements Lack of GMP inspection history of China drug manufacturing sites China conducted clinical trials that did not meet GCP requirements Sponsor responsibilities of clinical trials conducted in China that do not follow GCP/EMA requirements China-based companies unaware of the EMAs administrative r
37、equirements(e.g.,established in the EU)as a prerequisite for submissions of MAAs to EMAProcedural and regulatory know-how for China biotech in the EU8China NMPAEuropean Medicines AgencyCultureQuestions and product strategy are driven by NMPA.MAHs are encouraged to present viewpoints with supportive
38、evidence and ask questions to drive positive outcomes.LegislationRegulations and legislation are not fully harmonised internationally,and a requirement in the EU may not apply in China.EU legislation largely harmonised with global guidelines,including ICH.However,additional guidelines are required t
39、o follow for China.TimelinesTakes 270 350 days for the full registration process.Takes approximately one year(277 days until EC decision)for full registration;however,some forms of accelerated assessment can be within shorter timelines.Accelerated assessment proceduresDiscuss justification for accel
40、erated review with CDE prior to MAA submission,but confirmation is only given once MAA and priority review are submitted to CDE.Advice to discuss the justification for accelerated assessment.Applicant submits a formal request for confirmation from CHMP prior to MAA submission.Recommend scientific ad
41、vice to discuss the justification for accelerated assessment.Applicant submits a formal request for confirmation from CHMP prior to MAA submission.Orphan drugNo formal definition,although a conditional approval pathway is followed,and global data is accepted.The formal definition of rare diseases an
42、d criteria that must be met to qualify as orphan medicines.If granted,expedited pathway and other incentives.QualityFollows the Chinese Pharmacopoeia(CP),ICH and Chinas own regulations.Follows the European Pharmacopoeia(EP),ICH and EMAs own regulations.Figure 2-Ways in which the approvals process fo
43、r NMPA and EMA differ9Procedural and regulatory know-how for China biotech in the EUClinical trial and clinical dataChina-based biotech companies need to evaluate pivotal studies conducted globally with respect to EMA/GCP requirements and sponsor responsibilities,e.g.,on sponsor oversight on trial a
44、ctivities and TMF management.The GCP status,GCP and inspection history,and the risk for the imposition of GCP inspections during a marketing authorisation procedure need to be assessed.If the studies have only been conducted in Asia with a local population,and if the product is viewed as ethnically
45、sensitive or there are extrinsic factors such as differing medical practise,there may be a need for a bridging study or,in the worst case,an additional pivotal study may be required.This should be evaluated early on,assessing both clinical and non-clinical data.Administrative challenges to China-bas
46、ed biotech companies when entering the EUStrategic regulatory services can support China-based biotech companies that need to meet the EU and EMA administrative requirements prior to filing a marketing authorisation application to the EMA and aid with establishing these companies in the EU(establish
47、ment of EU-based offices).This aid is essential as the EMA conducts consistency checks of registered addresses of the global offices and manufacturing sites of those applying for authorisation in the EU;these checks include monitoring consistency in the trade registration,EU SPOR database,DUNS regis
48、trations and company data in respective application forms.Administrative requirements in the European Union include the following:Headquarters and establishment in the EU Trade register DUNS number Consistency of company names Global restructuring processes including,e.g.,company name changes,change
49、s of DUNS numbers and set-up of new companies and officesProcedural and regulatory know-how for China biotech in the EU10Understanding EMA regulatory processes and the EU centralised procedure for marketing authorisationThe centralised procedure is the European Union-wide procedure for the authorisa
50、tion of medicines,where there is a single application,a single evaluation,and a single authorisation throughout the European Union.China-based companies need to understand the regulatory requirements of the European Medicines Agency in contrast to Asian/Chinese Health Authorities.For example,only ce
51、rtain medicinal products are eligible for the centralised procedure.The centralised procedure is compulsory for human medicines containing a new active substance to treat human immunodeficiency virus or acquired immune deficiency syndrome(AIDS),cancer,diabetes,neurodegenerative diseases,autoimmune a
52、nd other immune dysfunctions,viral diseases,medicines derived from biotechnology processes,advanced-therapy medicines,and orphan medicines.It is optional for medicines containing new active substances for indications other than those stated above that are a significant therapeutic,scientific,or tech
53、nical innovation and whose authorisation would be in the interest of public or animal health at the EU level.As a China-based company,new ways of communication and interactions with the EMA must be established.The China-based applicant needs to set up web-based EMA accounts to enable communication w
54、ith EMA,EMA offices,rapporteurs and other scientific committees involved in MAA evaluations in the centralised procedure.11Procedural and regulatory know-how for China biotech in the EURecommended early engagement of China-based companies with EU EMA and national regulatory authoritiesDue to the com
55、plex product nature and the need for a bespoke development strategy,it is strongly recommended that China-based biotech companies engage the relevant regulatory authorities early and participate in ongoing communication prior to the submission of a letter of intent to the EMA,to announce the intenti
56、on of the applicant to apply for marketing authorisation,ideally as early as possible during development,but there is opportunity to engage with the EMA and other European health authorities throughout.ICONs Strategic Regulatory teams experience has proven to be invaluable in leading these interacti
57、ons with EMA,whether it be with the CHMP EMA rapporteur and co-rapporteur(first contact at the occasion of a pre-submission meeting)or EMA product lead,as well as national scientific advisory groups,and PV,GCP and GMP inspection teams.Figure 3-Outline of the EMA scientific advice procedure-EMA scien
58、tific advice briefing documentation preparation-Draft briefing document for submission via IRIS-EMA advice briefing-Response to questions-Final briefing document submission via IRIS-Day 40 CHMP opinion-Notification if discussion meeting is requiredBriefing preparation beginsEMA scientific advice val
59、idationScientific advice procedure beginsDay 70 CHMP opinion and scientific advice1 month4-5 months1234EMA Scientific Advice Procedure-One month preparation of briefing document and four month scientific advice procedureProcedural and regulatory know-how for China biotech in the EU12Early and late i
60、nteractions between the applicant and European Medicines Agency at scientific advice meetingsLate-stage scientific advice procedures are initiated and conducted by ICONs Strategic Regulatory team to prepare the applicants submission to the EMA for approval.In this stage of development,ICONs Strategi
61、c Regulatory team considers two procedures:A.Scientific advice procedures to clarify late-stage scientific questions B.Pre-submission meetings to prepare for any administrative and technical questions of the submission Some additional regulatory considerations considering marketing authorisation app
62、lications in the centralised procedure include:In the EU,early dialogue with the EMA can be initiated by a national or EMA scientific advice meeting.This is an opportunity to discuss all aspects of drug development,from paediatric plans,orphan drug designation,ATMPs,innovative products and unmet med
63、ical needs.The scientific advice meeting will help shape the strategic plans of China-based biotechs to best optimise their approach.This dialogue,it will help the EMA to familiarise itself with the new product and the technology around it,ensuring a smoother review for the eventual submission of an
64、 MAA.In turn,scientific advice may be beneficial to help understand EU medicine regulations and is available for micro,small and medium-sized enterprises(SMEs).Depending on the nature of the biotech product and the size of the company,there are a number of benefits available,whether protocol assista
65、nce,reduced fees,expedited approval pathways and market exclusivity on approval.These options should be identified and agreed upon with the EMA as early as possible to ensure that the biotech company completes all the necessary steps procedurally.To seek advice in China,biological products are broke
66、n into different categories depending on where the product originates from,for example in for therapeutic biologicals in China,there are three categories:Category 1 Innovative biological products not available in China or abroad Category 2 Improved product over domestic or overseas listed product Ca
67、tegory 3 Domestic or overseas listed biological productThe distinction of the three categories is used to delineate the possible pre-submission meetings with the NMPA:Category I Meeting to address major safety issues encountered during clinical trials or major technical issues during product develop
68、ment Category II Meetings held during drug development common times for these meetings Before the start of Phase 1 trial At the end of Phase II or at the start of Phase III Before submission of the NDA To review the risk assessment controls in place Category III Meetings for subjects other than thos
69、e in Category I and II13Procedural and regulatory know-how for China biotech in the EUCase study:China-based biotech applications post-COVID-19ICON has the privilege of working with a China-based medium-sized biopharmaceutical company with office locations in many countries.Toward the end of 2020,th
70、e company requested ICONs regulatory support for its supportive treatment for patients with cancer.The company sought out ICONs services to help it achieve a successful marketing authorisation application in the centralised procedure of the EMA.For this application,ICONs staff needed to organise a p
71、re-submission meeting with the EMA and the rapporteur and co-rapporteur preparation of the submission package(including the Common Technical Document).The sponsor needed ICON to be the primary contact for the EMA with respect to all communications regarding the submission package,procedure managemen
72、t and timelines.ChallengesThe uncertainties caused by the COVID-19 pandemic travel restrictions have caused major delays for many China-based pharmaceutical companies that are looking to get approvals in the EU;this sponsor also fell victim to these delays.The Chinese Government are very strict with
73、 their COVID-19 travel laws,which has led to the temporary suspension of on-site GCP and GMP inspections by the EMA in China.ICON is currently applying optimal response management to Day 120 and Day 180 questions of the CHMP to compensate for procedure delays from the COVID-19 situation in China.Sol
74、utionsICON and the client have agreed to offer various procedural and administrative support to the EMA to facilitate its staff to travel to China and conduct the GCP and GMP inspections.ICON is also utilising its strong project leadership and experience with previous EMA marketing authorisation pro
75、cedures to allow us to foresee data-related and procedural issues and proactively initiate compensation measures.Effective meeting and communication management has allowed ICON to achieve close cooperation with client management and subject matter experts distributed across the globe in all major re
76、gulatory regions.Procedural and regulatory know-how for China biotech in the EU14Early engagement and regulatory considerations for biotechWhat companies must consoder when developing an assetMoving beyond a buzzwordHow small-to mid sized biotechs can adopt patient centricity in their oncology trial
77、sDriving high quality in global clinical drug developmentHow Chinese based biotech employed FSP solution to deliver improved quality,performance and team managementEuropes emerging biotechsChallenges,opportunitites,funding and partnershipsA multitude of factors and EU and EMA-specific requirements n
78、eed to be considered by China-based biotech and pharmaceutical companies prior to filing a marketing authorisation application in the centralised procedure in the EU.ConclusionNavigating non-clinical,clinical and CMC drug development for medicinal products that are eligible for the centralised proce
79、dure is challenging from many perspectives and requires a customised development strategy,especially for China-based companies with limited EU experience.ICON has experience in providing regulatory direction and strategy to China-based clients during and after the preparation for regulatory submissi
80、ons in the centralised procedure to the European Medicinal Agency.ICONs regulatory strategy and interaction plan for sponsors in China smoothly guide their marketing authorisation applications in the centralised procedure to the EMA and allow the marketing authorisation holder that works with us to
81、market a drug product.To learn more about how ICONs regulatory team can bring your China-based biotech to Europe,contact us at:ICON readingEarly engagement and regulatory considerations for biotechICON companies must consider when developing an assetJune 2019Moving Beyond a Buzzword:How small-to mid
82、-sized biotechs can adopt patient centricity in their oncology trialsDespite the fact that 70 percent of Americans have reported being inclined or even very willing to participate in a trial,only about five percent of all adult cancer patients are enrolled in cancer clinical trials.According to the
83、FDA,eligibility criteria cause the exclusion of some patients,but adopting patient-centric elements into oncology clinical trials has the potential to increase patient recruitment and retention.There are multiple opportunities for companies to integrate the patient perspective either on their own or
84、 with the help of CROs.While the task can seem daunting for small-or medium-sized biotechs that may not have the financial or human resources,it doesnt have to be even if its only making one change at a time.Now is the time to adopt patient-centric strategies that not only focus on patient needs,but
85、 also can maintain cost efficiency.Some of these strategies include developing materials and tools to help sites enhance patient awareness of trials,creating better consent and education materials,and bringing the patient voice in at the beginning of protocol design.While incorporating all of these
86、changes to a trial is unrealistic,sponsors can achieve success by setting a strategy based on the specific needs of the study.By making two to three defined changes for each new clinical trial,sponsors are able to decrease the patient burden and therefore increase consideration of trial participatio
87、n.Ultimately,this impacts the overall enrollability of the study and helps avoid additional cost and time to their clinical trial.Here we discuss how small and medium biotech companies can take those steps in a cost effective and time sensitive manner to design more patient-centric approaches in onc
88、ology clinical trials.This includes introducing best practices for connecting with cancer patients and using their input to reduce patient burden in oncology clinical trials,including protocol design,social media,and concierge support.Clinical trials in oncology can be costly and challenging to mana
89、ge,often making drug development risky and time consuming.One factor that could reduce costs is speeding patient enrollment by integrating the patient voice in trial design.Lucy Clossick Thomson Senior Director of Oncology Project Management,ICON Clinical ResearchSusan CampbellDirector of Patient Re
90、cruitment,ICON Clinical ResearchAuthorsICON 2019 ICON plc.Allrights reserved.Case study Driving high quality in global clinical drug developmentHow Chinese based biotech employed FSP solution to deliver improved quality,performance and team management.The challengeWith the focus on internal developm
91、ent this client was facing two major challenges that they anticipated would put this strategy at risk if not addressed head-on:1.The rapidly expanding study portfolio required an exponential increase in the number of Clinical Research Associates(CRAs)and Clinical Trial Assistants(CTAs)where our clie
92、nt experienced difficulties hiring due to the intense competition for talent in the Chinese market.2.They found their increasingly limited internal capacity to manage,hire and train their resources,within tight timeframes demanded by the business,was becoming a major risk to meeting study milestones
93、 and quality.Adopting a FSP partnership allowed the company to continue to have full control over the clinical trial operations and retain their internal development strategy while insourcing an FSP team that was fully trained and supported by ICON.This client had made the strategic decision to focu
94、s on internal development instead of outsourcing their studies.ICON Strategic Solutions,the global leader in Functional Service Provision(FSP)had established a working relationship with a local biotech company in China as a provider of contract staff.For local biotech companies,there are usually thr
95、ee options to choose from:To outsource the trials completely Focus on hiring more resources through a vendor Use a FSP solution to relieve some management burden and provide scalability to meet demandICON approachOur comprehensive strategy focused not only on the management and sourcing of resources
96、 but on assuring the high-quality delivery of the trials.ICON University,our in-house training platform and dedicated specialist team,provided the framework for coaching and workshops to ensure best practice through a sustainable train-the-trainer model.In addition,line managers accompanied CRAs on
97、site visits for hands on training with a focus on cultivating site relationships.Our team took ownership of this challenge and solved their resourcing issues while also relieving the team management burden and maintaining high levels of quality.Beyond this,ICON expanded and evolved their services in
98、 tandem with client development needs to maintain a sustainable partnership for 6 years as sole FSP provider.The team grew from 1 to 130,with broad career development from CRAs expanding to CTA,Operations Manager(OM),Project Manager and Trainer.ICONs Own It culture adopts a solution-orientated appro
99、ach to build the One Team concept with the client,proactively provide insights and co-develop the process/infrastructure to optimise operation team management flow and resolve the clients challenges by utilising our FSP expertise.In 2022,with the expansion of the clients scale and further improvemen
100、t of quality and company culture requirement,our goal was not just ensuring delivery with high quality,but also accommodating their need to help optimise management infrastructure with the purpose to build up a high performance ONE TEAM.July 2021Europes emerging biotechsChallenges,opportunities,fund
101、ing and partnershipsJohn MacdonaldVice President,Venture&Financial Alliances at ICONICON is at the heart of processes as varied as brewing beer to genetic modification,and it is a field that continues to grow.By harnessing biological processes on a cellular and biomolecular level,biotech is benefitt
102、ing industries as varied as agriculture or chemical production.Perhaps the most prominent of these industries is biopharma.In fact,during the time period from 2014-2020 the European Unions(EUs)Horizon 2020 which provided research and innovation funding for multi-national collaboration projects,as we
103、ll as for individual researchers estimated that one fifth of current medicines and up to half of new medicines were derived from biotech.The European biotech market varies in some significant ways from other markets,particularly in the US where there is a deep pool of venture capital resources to dr
104、aw upon.For European biotechs,this source of capital is much harder to come by.But because of the high competition for funds in Europe,the cost of investment is lower for the same high quality of work.For European biotechs that choose to go public,many choose to launch initial public offerings(IPOs)
105、in the US in order to draw a higher performance.Additionally,Europe is uniquely complex because of how many smaller markets it contains.Under the umbrella of the EU and the European Medicines Agency(EMA)there are dozens of countries with differing pathways for biotech companies,as well as distinct h
106、ealthcare and reimbursement systems.Contributing to the complexity are those countries such as Russia and recently the UK which are not EU members and,therefore,do not come under the purview of the EMA.This means that biotechs in each country must approach R&D differently,and must consider the stand
107、ards and healthcare policies of any country they may hope to market in.As can be expected of such a broad geography,Europe has its own clusters of biotech innovation.The United Kingdom,and its golden triangle of Oxford,Cambridge and London,is one key leader with a quickly growing number of startups
108、and at the top of public funding as reported in 2019.1,2 Other biotech centers that are leading innovation and expanding their influence include Germany,France,Switzerland and the Netherlands.With the acumen and innovation of these and other centers of biotech,Europe is already a major force in the
109、field of biotech,as a whole,and has the potential to grow even further.As biotech finds itself in the eye of the public and investors,it becomes useful to evaluate its current state in Europe,including what the pandemic has changed for biotech,key areas of biotech innovation and how biotech companie
110、s are being funded.Download whitepaperDownload media articleDownload case studyDownload media article15Procedural and regulatory know-how for China biotech in the EUReferences1.European regulatory system for medicines and the European Medicines Agency-A consistent approach to medicines regulation ac
111、ross the European Union.2.European Commission:Safe medicines for the EU(EMA webpage)3.Schuessler-Lenz M,et al.Regulators advice can make a difference:European Medicines Agency approval of Zynteglo for beta thalassemia.Clinical Pharmacology&Therapeutics 2020;107(3):492494.4.European Medicines Agency
112、pre-authorisation procedural advice for users of the centralised procedure5.Best practice guide on measures improving predictability of submissions/responses and adherence to communicated submission/responses deadlines6.Standard Operating Procedure.Eligibility to the centralised procedure for medici
113、nal products for human use(EMA)7.European Medicines Agency.Applying for EU Marketing Authorization.For medicinal products for human use(2015).8.European Medicines Agency.User guide for micro,small and medium-sized Enterprises(2016)Intelligence to Impact.ICON is a clinical research organisation power
114、ed by the strategic application of healthcare intelligence.Were evolving clinical research,creating impactful outcomes for our clients and their patients.Intelligent insights.Impactful results.ICONICON plc Corporate HeadquartersSouth County Business ParkLeopardstown,Dublin 18Ireland T:(IRL)+353 1 29
115、1 2000T:(US)+1 215 616 3000F:+353 1 247 6260ICON ICONICON is the worlds leading clinical research organisation,powered by healthcare intelligence.From moleculeto medicine,we advance clinical research providing outsourced development and commercialisation servicesto pharmaceutical,biotechnology,medic
116、al device and government and public health organisations.We developnew innovations,drive emerging therapies forward and improve patient lives.With headquarters in Dublin,Ireland,ICON operates from 99 locations in 46 countries and has approximately 41,150 employees as of 1 January 2023.2023 ICON plc.All rights reserved.