FrancophonIA/ELRC3.0 huggingface dataset:
English: The nature of immune reactions depends on many factors
Slovenian: Narava imunskih reakcij je odvisna od številnih dejavnikov
English: The EU legislation imposes strict requirements for the manufacture of all medicines:
Slovenian: Zakonodaja EU vsebuje stroge zahteve za proizvodnjo vseh zdravil:
English: The studies to prove pharmaceutical quality should provide detailed data on:
Slovenian: Študije za dokazovanje farmacevtske kakovosti morajo zagotoviti podrobne podatke o:
English: Reason for varying amount/type of data
Slovenian: Razlog za različno količino/vrsto podatkov
English: In general, the amount and type of data will depend on several factors, including:
Slovenian: Na splošno sta količina in vrsta podatkov odvisni od več dejavnikov, vključno z:
English: Large molecular structure
Slovenian: Velika molekularna struktura
English: This guide was last updated on 02/10/2019
Slovenian: Ta priročnik je bil nazadnje posodobljen 10/02/2019.
English: The immune system has the ability to recognise foreign proteins and react against them.
Slovenian: Imunski sistem ima sposobnost, da prepozna tuje beljakovine in se odzove nanje.
English: A robust regulatory framework to protect patients' safety
Slovenian: Trden regulativni okvir za zaščito varnosti pacientov
English: Additional monitoring and black triangle
Slovenian: Dodatno spremljanje varnosti in črni trikotnik
English: Does not affect the pharmaceutical quality of the medicine (no impact on product specifications)
Slovenian: Ne vpliva na farmacevtsko kakovost zdravila (brez vpliva na specifikacije zdravila)
English: Obtained from a biological source
Slovenian: Pridobljeno iz biološkega vira
English: Possibility of extrapolating to other indications
Slovenian: Možnost ekstrapolacije na druge indikacije
English: Of more than 50 biosimilars approved in the EU to date, none has been withdrawn or suspended for reasons of safety or efficacy.
Slovenian: Med več kot 50 podobnimi biološkimi zdravili, ki so bila doslej odobrena v EU, nobeno ni bilo umaknjeno ali začasno odvzeto iz razlogov, povezanih z varnostjo ali učinkovitostjo.
English: Same strict standards of quality, safety and efficacy
Slovenian: Enaki strogi standardi kakovosti, varnosti in učinkovitosti
English: Healthy volunteers can be selected if they represent the most appropriate population to detect such differences and if the medicines' toxicity is not a cause of concern.
Slovenian: Zdravi prostovoljci se lahko izberejo, če predstavljajo najprimernejšo populacijo za odkrivanje takih razlik in če toksičnost zdravil ni razlog za zadržek.
English: No previous knowledge of safety and efficacy
Slovenian: Brez predhodnega znanja o varnosti in učinkovitosti
English: Determining factor
Slovenian: Odločilni dejavnik
English: From a scientific and regulatory point of view, the reference medicine's entire clinical development programme does not need to be repeated.
Slovenian: Z znanstvenega in regulativnega vidika ni treba ponoviti celotnega programa kliničnega razvoja referenčnega zdravila.
English: Analytical studies are the first step in assessing potential for immunogenicity.
Slovenian: Analitične študije so prvi korak pri ocenjevanju imunogenega potenciala.
English: Usually produced by chemical synthesis
Slovenian: Običajno pridobljeno s kemično sintezo
English: (‘microheterogeneity').
Slovenian: (tj.„mikroheterogenosti“).
English: Complexity of the molecule and comparability data available
Slovenian: Kompleksnost molekule in razpoložljivi primerjalni podatki
English: Generally possible to obtain exactly the same molecule
Slovenian: V splošnem je mogoče izdelati povsem enako molekulo
English: May possibly affect safety or efficacy
Slovenian: Lahko vpliva na varnost ali učinkovitost
English: Amount of non-clinical data determined by the outcome of quality studies
Slovenian: Količina nekliničnih podatkov je določena na podlagi izidov študij kakovosti
English: The extent of clinical studies needed for approval depends on several factors, including those outlined in table 6.
Slovenian: Obseg kliničnih študij, potrebnih za odobritev, je odvisen od več dejavnikov, vključno s tistimi, ki so opisani v preglednici 6.
English: They should represent the largest difference in efficacy that would not matter in clinical practice; treatment differences within this range would thus be acceptable because they have no clinical relevance.
Slovenian: Predstavljati morajo največjo razliko v učinkovitosti, ki v klinični praksi ne bi bila pomembna; razlike v zdravljenju znotraj tega razpona bi bile tako sprejemljive, ker niso klinično pomembne.
English: Extrapolation of immunogenicity data is not automatic, as it always requires justification.
Slovenian: Ekstrapolacija podatkov o imunogenosti ni samoumevna, saj vedno zahteva utemeljitev.
English: Clinical trials are needed only if an impact on safety and efficacy is anticipated (scenario 3).
Slovenian: Klinična preskušanja so potrebna le, če se pričakuje vpliv na varnost in učinkovitost (scenarij 3).
English: How healthcare professionals can help improve pharmacovigilance for biological medicines:
Slovenian: Kako lahko zdravstveni delavci pomagajo izboljšati farmakovigilanco pri bioloških zdravilih:
English: As healthcare professionals are at the forefront of patients' care, it is vital that they have access to reliable information on these medicines: what they are and what scientific principles support their clinical development, approval and safety monitoring.
Slovenian: Zdravstveni delavci imajo vodilno vlogo pri oskrbi pacientov, zato je ključnega pomena, da imajo dostop do zanesljivih informacij o teh zdravilih: kakšna so in katera znanstvena načela podpirajo njihov klinični razvoj, odobritev in spremljanje varnosti.
English: This minor variability must fall within the acceptable range to ensure consistent safety and efficacy.
Slovenian: Ta manjša variabilnost mora biti znotraj sprejemljivega razpona, da bi dosledno zagotavljali varnost in učinkovitost.
English: Where applicable, the assessment report also includes the scientific rationale for extrapolation of data.
Slovenian: Kadar je primerno, poročilo o oceni vključuje tudi znanstveno utemeljitev ekstrapolacije podatkov.
English: In the EU, prescribing practices and advice to prescribers fall under the responsibility of Member States, which have the necessary legal framework in place and issue regulations, guidelines and advice in their areas of competence.
Slovenian: V EU so prakse predpisovanja zdravil in svetovanje predpisovalcem zdravil v pristojnosti držav članic, ki imajo vzpostavljen potreben pravni okvir ter izdajajo predpise, smernice in mnenja na svojih področjih pristojnosti.
English: Growth hormone 22,000 daltons
Slovenian: Rastni hormon 22 000 daltonov
English: Thus, they are expected to be less costly for healthcare systems in the EU.
Slovenian: Zato je moč pričakovati, da bodo zdravstvenim sistemom v EU omogočila nižje stroške.
English: Biological medicines approved after 1 January 2011 are subject to socalled ‘additional monitoring' and are included in a list of medicines under ‘additional monitoring'.
Slovenian: Biološka zdravila, odobrena po 1. januarju 2011, so predmet tako imenovanega „dodatnega spremljanja varnosti“ in so vključena na seznam zdravil z „dodatnim spremljanjem varnosti“.
English: Foreword by Prof. Guido Rasi EMA Executive Director
Slovenian: Uvodna beseda prof. Guido Rasi, izvršni direktor Evropske agencije za zdravila
English: The expertise acquired over the last 10 years has enabled EU regulators to integrate experience-based knowledge with the initial sciencedriven concept.
Slovenian: Strokovno znanje, pridobljeno v zadnjih desetih letih, je regulativnim organom v EU omogočilo integracijo znanj, ki temeljijo na izkušnjah, v prvotni znanstveno naravnani koncept.
English: Type of manufacturing change
Slovenian: Vrsta spremembe proizvodnje
English: There is also no reason to believe that harmful immunogenicity should be expected after switching between highly similar biological medicines
Slovenian: Prav tako ni razloga, da bi verjeli v pričakovano škodljivo imunogenost, ki bi nastala po preklopu med visoko podobnimi biološkimi zdravili8.
English: Immunogenicity is not a safety concern in itself
Slovenian: Imunogenost sama po sebi ni vzrok za zadržke glede varnosti
English: If some manufacturing steps take place outside the EU, then non-EU manufacturers, importers and wholesale distributors are obliged to follow the same strict requirements and are also regularly inspected.
Slovenian: če nekatere faze proizvodnje potekajo zunaj EU, morajo proizvajalci s sedežem zunaj EU, uvozniki in veletrgovci z zdravili upoštevati enako stroge zahteve, prav tako pa se pri njih redno opravljajo inšpekcijski pregledi.
English: Medicines are approved when studies on their pharmaceutical quality, safety and efficacy convincingly demonstrate that the medicine's benefits outweigh the risks (‘positive benefit-risk balance').
Slovenian: Zdravila se odobrijo, če študije o njihovi farmacevtski kakovosti, varnosti in učinkovitosti prepričljivo dokazujejo, da so koristi zdravila večje od tveganj („pozitivno razmerje med koristjo in tveganjem“).
English: Other international regulators such as Australia's TGA directly apply the principles set out in the EU legislation for the development and approval of biosimilars.
Slovenian: Drugi mednarodni regulativni organi, kot je avstralski regulativni organ za zdravila TGA, neposredno uporabljajo načela, določena v zakonodaji EU za razvoj in odobritev podobnih bioloških zdravil.
English: Prepared jointly by the European Medicines Agency and the European Commission
Slovenian: Skupaj pripravili Evropska agencija za zdravila in Evropska komisija
English: For questions on prescribing or interchangeability practices, information may be available at the national competent authority in the relevant Member State (the list can be found on EMA's website).
Slovenian: Za vprašanja o praksah predpisovanja ali zamenljivosti so informacije na voljo pri pristojnem nacionalnem organu v zadevni državi članici (seznam je objavljen na spletnih straneh Evropske agencije za zdravila).
English: This guide has been prepared by the European Medicines Agency in collaboration with the European Commission and scientific experts from EU Member States.
Slovenian: Ta priročnik je pripravila Evropska agencija za zdravila v sodelovanju z Evropsko komisijo in strokovnjaki iz držav članic EU.
English: The amount of data normally depends on the type and severity of the safety concerns identified for the reference medicine.
Slovenian: Količina podatkov je običajno odvisna od vrste in resnosti vprašanj glede varnosti, opredeljenih za referenčno zdravilo.
English: European Medicines Agency: Guideline on good pharmacovigilance practices (GVP), Product- or Population-Specific Considerations II: Biological medicinal products.
Slovenian: Evropska agencija za zdravila: Guideline on good pharmacovigilance practices (GVP), Product- or Population-Specific Considerations II: Biological medicinal products.
English: This covers the time from release by the manufacturer and progress through the entire distribution chain until the medicine is administered to the patient.
Slovenian: To vključuje čas od proizvajalčeve sprostitve zdravila in se nadaljuje skozi celotno preskrbovalno verigo do trenutka, ko zdravilo prejme pacient.
English: This list includes medicines authorised in the EU that are being monitored particularly closely by regulatory authorities, for example because the active substance is new to the market or there are limited data on its long-term use.
Slovenian: Seznam vključuje zdravila, odobrena v EU, ki jih regulativni organi še posebno skrbno spremljajo, na primer zato, ker je zdravilna učinkovina nova na trgu ali ker so podatki o njeni dolgotrajni uporabi omejeni.
English: Biotechnology
Slovenian: Biotehnologija
English: Development aims at demonstrating safety and efficacy directly in patients
Slovenian: Cilj razvoja je dokazati varnost in učinkovitost neposredno pri pacientih
English: Regulatory authorities review reports for any signal suggestive of a possible unwanted effect.
Slovenian: Regulativni organi pregledajo poročila, da ugotovijo, ali obstaja kakršen koli signal, ki nakazuje morebiten neželeni učinek.
English: Insulin 5,808 daltons
Slovenian: Inzulin 5 808 daltonov
English: World Health Organisation
Slovenian: Svetovna zdravstvena organizacija
English: Biomanufacturing strictly regulated
Slovenian: Bioproizvodnja je strogo urejena
English: This also binds the company to register the study in the publicly available EU PAS Register: http://www.encepp.eu/ encepp_studies/indexRegister.shtml.
Slovenian: To tudi zavezuje imetnika dovoljenja, da študijo registrira v javno dostopnem EU PAS registru, kjer so tovrstne študije evidentirane: http://www.encepp.eu/encepp_ studies/indexRegister.shtml.
English: Compared with small chemical substances, biological medicines consist of large and often complex molecular structures.
Slovenian: V primerjavi z majhnimi kemičnimi molekulami biološka zdravila vsebujejo velike in pogosto zapletene molekularne strukture.
English: If a biological medicine (or biosimilar) is labelled with a black triangle, it does not necessarily mean that there are additional safety concerns with it.
Slovenian: Če je biološko zdravilo (ali podobno biološko zdravilo) označeno s črnim trikotnikom, to še ne pomeni, da obstajajo dodatni zadržki glede njegove varnosti.
English: The EU has a well-established system for monitoring, reporting, assessing and preventing adverse drug reactions for all medicines, including all biological medicines.
Slovenian: EU ima dobro uveljavljen sistem za spremljanje, sporočanje, ocenjevanje in preprečevanje neželenih učinkov zdravila za vsa zdravila, vključno z vsemi biološkimi.
English: The aim of studies in humans is not to demonstrate safety and efficacy in patients, as these have already been established for the reference medicine.
Slovenian: Cilj študij na ljudeh ni dokazati varnosti in učinkovitosti pri pacientih, saj sta bili ti že dokazani za referenčno zdravilo.
English: Telephone +31 (0)88 781 6000 Send a question www.ema.europa.eu/contact www.ema.europa.eu
Slovenian: Telefon: +31 (0)88 781 6000 Pošljite vprašanje www.ema.europa.eu/contact www.ema.europa.eu
English: Factors affecting the number and types of clinical studies to be carried out for approval Determining factor
Slovenian: Dejavniki, ki vplivajo na število in vrste kliničnih študij, ki jih je treba izvesti za odobritev
English: This enables prompt identification and analysis of information about the medicines to add to the knowledge gained during clinical trials.
Slovenian: To omogoča hitro identifikacijo in analizo informacij o zdravilu, s katerimi se dopolnjuje znanje, pridobljeno med kliničnimi preskušanji.
English: In the case of monoclonal antibodies they are always required, as it is more difficult to predict the incidence of unwanted immunogenicity, the characteristics of the immune response or the clinical consequences.
Slovenian: V primeru monoklonskih protiteles se zahtevajo vedno, saj je težje predvideti pojavnost neželene imunogenosti, značilnosti imunskega odziva ali kliničnih posledic.
English: Although immunogenicity could be a potential concern for all biological medicines, there are several important considerations:
Slovenian: Čeprav bi imunogenost lahko vzbujala zaskrbljenost pri vseh bioloških zdravilih, obstaja več pomembnih vidikov:
English: Safety concerns with the reference medicine or pharmacological class
Slovenian: Zadržki glede varnosti referenčnega zdravila ali farmakološkega razreda
English: A medicine obtained by biotechnology often has been produced by inserting a gene into cells so that they can produce the desired protein.
Slovenian: Zdravilo, pridobljeno z biotehnologijo, se pogosto proizvaja z vstavitvijo gena v celice, tako da lahko proizvedejo želeno beljakovino.
English: Technology that involves combining sequences of DNA that do not occur naturally, for example inserting a gene for producing a therapeutic protein.
Slovenian: Tehnologija, ki vključuje kombiniranje zaporedij DNK, ki niso naravno prisotna, na primer vstavljanje gena za proizvodnjo terapevtske beljakovine.
English: Information needs and feedback from EU healthcare professionals' organisations have been sought throughout the preparation of this document.
Slovenian: Potrebe po vrstah informacij in povratne predloge so sodelujoči pridobivali s strani organizacij zdravstvenih delavcev iz EU med celotno pripravo tega dokumenta.
English: If clinical studies are needed, these are conducted in one relevant indication and, based on all these data, extrapolation to the other indications is usually possible.
Slovenian: Če so potrebne klinične študije, se izvedejo za eno zadevno indikacijo, na podlagi vseh teh podatkov pa je običajno mogoča ekstrapolacija na druge indikacije.
English: After demonstration of biosimilarity, extrapolation of data to other indications is possible if the scientific evidence available addresses all specific aspects of these indications
Slovenian: Po ugotovitvi biološke podobnosti je ekstrapolacija podatkov na druge indikacije mogoča, če razpoložljivi znanstveni dokazi obravnavajo vse posebne vidike teh indikacij
English: Differences that may affect clinical safety, efficacy or immunogenicity need to be further studied (e.g. in comparative non-clinical or clinical studies, step 2 and 3).
Slovenian: Razlike, ki lahko vplivajo na klinično varnost, učinkovitost ali imunogenost, je treba dodatno proučiti (npr. s primerjalnimi nekliničnimi ali kliničnimi študijami, 2. in 3. korak).
English: Equivalence margins are set specifically for the indication studied and depend on the endpoint chosen.
Slovenian: Območja ekvivalence se določijo posebej za proučevano indikacijo in so odvisna od izbrane končne točke.
English: Most often, analytical and functional data are sufficient, and clinical trials to prove safety and efficacy are not needed (table 5, scenario 1 and 2).
Slovenian: Najpogosteje zadostujejo analitični in funkcionalni podatki, tako da klinična preskušanja za dokazovanje varnosti in učinkovitosti niso potrebna (preglednica 5, scenarija 1 in 2).
English: Studies of how a medicine is processed by the body, including its absorption, distribution, biotransformation and excretion.
Slovenian: Študije o tem, kako telo transportira in presnavlja zdravilo, vključno z njegovo absorpcijo, porazdelitvijo, biotransformacijo in izločanjem.
English: Extrapolation of safety data
Slovenian: Ekstrapolacija podatkov o varnosti
English: Pharmacodynamic studies in vivo (animal models) are only done if no suitable in vitro model exists.
Slovenian: Farmakodinamske študije in vivo (živalski modeli) se izvedejo samo, če ne obstaja primeren model in vitro.
English: The scientific criteria for extrapolation of efficacy and safety data are supported by over 10 years experience of safe and effective use of biosimilars in the EU.
Slovenian: Znanstvena merila za ekstrapolacijo podatkov o učinkovitosti in varnosti so podprta z več kot desetletnimi izkušnjami glede varne in učinkovite uporabe podobnih bioloških zdravil v EU.
English: European Medicines Agency: Immunogenicity assessment of monoclonal antibodies intended for in-vivo clinical use.
Slovenian: Evropska agencija za zdravila: Immunogenicity assessment of monoclonal antibodies intended for in-vivo clinical use.
English: These WHO guidelines incorporate many of the scientific principles used by EMA and its scientific committees in EU guidelines, as EU experts have been closely involved in the preparation of the WHO guidelines.
Slovenian: Te smernice SZO vključujejo številna znanstvena načela, ki jih uporabljajo Evropska agencija za zdravila in njeni odbori v smernicah EU, saj strokovnjaki iz EU tesno sodelujejo pri pripravi smernic SZO.
English: In practice, variability (within a batch or batch-to-batch) is very low when using the same manufacturing process.
Slovenian: V praksi je variabilnost (znotraj serije ali med serijami) zelo majhna, če se uporablja enak proizvodni postopek.
English: Nearly all biosimilars approved for use in the EU have been approved centrally, as they use biotechnology for their production.
Slovenian: Skoraj vsa podobna biološka zdravila, odobrena za uporabo v EU, so bila odobrena s centraliziranim postopkom, saj se za njihovo izdelavo uporablja biotehnologija.
English: As for all clinical trials, legal requirements (e.g. Good Clinical Practice) have to be met.
Slovenian: Tako kot pri vseh kliničnih preskušanjih morajo biti izpolnjene pravne zahteve (npr. dobra klinična praksa).
English: Healthcare professionals play an essential role in contributing to the understanding of a medicine's safety profile during clinical use.
Slovenian: Zdravstveni delavci imajo s svojimi prispevki ključno vlogo pri razumevanju varnostnega profila zdravila v času njegove klinične uporabe.
English: All new medicines are closely monitored after being introduced to the market.
Slovenian: Vsa nova zdravila se po prihodu v promet, skrbno spremljajo.
English: An important requirement for the safety monitoring of all biological medicines is the need for product and batch traceability during clinical use and at all levels in the supply chain
Slovenian: Pomembna zahteva za varnostno spremljanje vseh bioloških zdravil je potreba po sledljivosti proizvoda in serije med klinično uporabo in na vseh ravneh preskrbovalne verige10.
English: Post-translational change
Slovenian: Sprememba po translaciji
English: Full non-clinical data (pharmacology and toxicology)
Slovenian: Popolni neklinični podatki (farmakologija in toksikologija)
English: Data requirements for approval: a scientifically tailored package
Slovenian: Zahtevani podatki za odobritev: znanstveno prilagojeni nabor
English: This is why additional pharmacovigilance activities (such as including patients in registries) could be required in certain cases.
Slovenian: Zato so lahko v nekaterih primerih potrebne dodatne farmakovigilančne aktivnosti (kot na primer vključevanje pacientov v registre).
English: To complement this, clinical data on immunogenicity are generally required; animal studies are of limited value in predicting immune response in humans.
Slovenian: Kot dopolnitev se običajno zahtevajo klinični podatki o imunogenosti; študije na živalih imajo omejeno vrednost pri napovedovanju imunskega odziva pri ljudeh.
English: This is partly due to a tailored development programme that builds on scientific knowledge gained with the reference medicine and so avoids unnecessary repetition of non-clinical and clinical studies.
Slovenian: Deloma je razlog za to prilagojeni program razvoja, ki temelji na strokovnem znanju, pridobljenem z referenčnim zdravilom, ter tako preprečuje nepotrebno ponavljanje nekliničnih in kliničnih študij.
English: Information guide for healthcare professionals
Slovenian: Informativni priročnik za zdravstvene delavce
English: These endpoints should preferably measure the pharmacological activity of the medicine and be less influenced by patient- or disease-related factors.
Slovenian: Te končne točke bi morale po možnosti meriti farmakološko aktivnost zdravila in biti manj dovzetne za vpliv dejavnikov, povezanih s pacienti ali boleznijo.
English: Limited physicochemical studies comparing batches before and after the change
Slovenian: Omejene fizikalno-kemijske študije, s katerimi se primerjajo serije pred spremembo in po njej
English: The guidelines have evolved to keep pace with rapid advances in biotechnology and analytical sciences, and they take on board increasing experience of clinical use.
Slovenian: Smernice se spreminjajo, da tako sledijo hitremu napredku na področju biotehnologije in analitskih znanosti ter pridobivajo vse večje izkušnje s klinično uporabo.
English: In addition to comparative pharmacokinetic and pharmacodynamic studies, safety and efficacy data may be required, particularly for more complex biological medicines
Slovenian: Poleg primerjalnih farmakokinetičnih in farmakodinamičnih študij se lahko zahtevajo tudi podatki o varnosti in učinkovitosti, zlasti za kompleksnejša biološka zdravila