Pharmeca info | Pharmeca a.s.

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CTIS byl zřízen farmaceutickým zákonem v rámci Nařízení o klinických studiích (Nařízení (EU) č. 536/2014) a po 30. lednu 2025 kompletně nahradí původní systém pro klinické studie EudraCT (Databáze klinických studií orgánů pro regulaci léčiv Evropské unie).

Evropská léková agentura (EMA) průběžně publikuje zprávy, jak proces přechodu na nový systém pokračuje.

V předchozím článku jsme ukazovali, jaká byla situace v únoru 2024, v tomto článku jsme informace o počtu podání a rozhodnutí o přechodu aktualizovali ke konci srpna 2024.

Obr. č. 1 – Změny v počtu podaných žádostí, resp. v počtu podání, kde již bylo rozhodnuto, v porovnání s předchozím měsícem

V průběhu léta aktivita podávání žádostí poklesla, ale ve srovnání se stavem v únoru je celkový počet podaných žádostí vice než dvojnásobný a počet studií s rozhodnutím je také skoro dvojnásobný.

Nicméně stále jsou klinické studie, pro které je třeba podat žádost.

EMA publikuje novinky v této oblasti každé dva týdny, kde mj. uvádí, jaké změny v systému CTIS provedla.

Také připravila Information Day for CTIS 17. října 2024 pro všechny zainteresované subjekty.

Uložte si datum do kalendáře a nepolevujte v přechodu vašich studií na nový systém.

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Důležité milníky pro klinické studie:

Klinické studie zahájené po 30. lednu 2023 – všechny žádosti o počáteční klinické studie v Evropské unii (EU)/Evropském hospodářském prostoru (EHP) musí být podány prostřednictvím CTIS
Klinické studie ukončené před 30. lednem 2025 – Klinická studie je spravována v systému EudraCT nebo národních systémech
Klinické studie, u kterých se očekává, že budou pokračovat po 30. lednu 2025 – je nutný přechod z EudraCT nebo národních systémů na CTIS.

Obr. č. 2 – schéma přechodu na nový informační systém pro klinická hodnocení

Save the date: EMA organizuje Information Day for CTIS 17. října 2024

Informační systém klinických studií (CTIS) – pokračující proces přechodu

Pharmeca a.s. 10/07/2024

min

CTIS was established by pharmaceutical law in the Clinical Trials Regulation (Regulation (EU) No 536/2014) and will completely replace the previous system for clinical trials EudraCT (European Union Drug Regulating Authorities Clinical Trials Database) after 30th January 2025. CTIS supports interactions between clinical trial sponsors (researchers or companies that run a clinical trial and collect and analyse the data) and regulatory authorities in the EU Member States and EEA countries, throughout the lifecycle of a clinical trial.

CTIS is guaranteed by European Medicines agency (EMA) and works in a secured workspace.

The important milestones for clinical trials:

CT starts after 30^th January 2023 – the submission must be completed through CTIS
CT ends before 30^th January 2025 – CT is maintained in EudraCT or national systems
CT is expected to continue after 30^th January 2025 – transition from the EudraCT or national systems to the CTIS is necessary.

Although the deadline is still 11 months away, according to the EMA's recommendations, the transition process should begin without delay. There are a few tricky points in the transition process that are worth noting.

The transition should take 2 months (according to the EMA methodology) but be prepared for a longer period. Once the process is complete, all information and data are processed through CTIS.
The new country should be included in clinical trial after the transition in all current clinical trial countries is complete.
The national language especially with special characters, can be a problem. You must provide labels in the national language.
Relation in workspace can be unstable, in which case the submission may not complete successfully and a resession may be required.

Because the system is not intuitive and not easy to use (experience), there are guidance and Q&As from EMA (link) as well as webinars (link) for users and sponsors.

EMA has also published an interesting video to improve awareness of the regulation of the clinical trials system: https://youtu.be/0nQ2ABHa9L0?feature=shared

In the next video, EMA introduces CTIS workspaces and common system functionalities to users: https://youtu.be/NSQmVtqhmWo?feature=shared

EMA publishes CTIS statistics weekly (link). Last published data from 6th to 12th February 2024:

Despite difficulties, until now there are 2473 successful submissions. However, there are also many CTs that must go through the transition either.

If this is also the case with your CT, don't delay any longer and go for the submission. Good luck, you'll make it.

EMA Legislation Pharmeca info

Clinical Trials Information System (CTIS) - present and future

CTIS podporuje interakce mezi sponzory klinických studií (výzkumníky nebo společnostmi, které provádějí klinickou studii a shromažďují a analyzují data) a regulačními orgány v členských státech EU a zemích EHP po celou dobu životního cyklu klinické studie.

Pharmeca 03/08/2024

min

Information for MAH Medicines Pharmeca info

Change in VAT Rates for Medicines

Based on the amendment to Act No. 235/2004 Coll., on Value Added Tax, as of January 1, 2024, there has been a change in VAT rates, particularly impacting the increase in prices and reimbursements for medicinal products. In the infographics, we will illustrate how the individual rates have changed and examine the international comparison to assess the impact on the Czech Republic.

Pharmeca a.s. 02/27/2024

min

První fáze cesty léku na trh je hlavně o ověřování účinnosti a bezpečnosti použití objevené látky u lidí a nastavení vhodných dávek, které jsou pro řešení dané nemoci ideální a zároveň jsou spojeny s minimálním výskytem nežádoucích účinků. Jedná se o klinická hodnocení.

Klinická hodnocení z pohledu evropské lékové agentury:

Další fází je proces registrační, kdy se předkládají k posouzení národní či evropské lékové agentuře veškeré informace zjištěné v předchozí klinické části, ale i podrobnosti k výrobě, uchovávání atp.

Udělená registrace pak pomyslně otvírá danému léku dveře na trh, ale zároveň držitele rozhodnutí o registraci (nejčastěji farmaceutickou společnost) zavazuje k dlouhodobému poregistračnímu sledování bezpečnosti. V případě zvýšeného výskytu nežádoucích účinků, interakcí s dalšími léky či zjištěním jakýchkoli nových skutečností, které se neprojevily v průběhu klinického hodnocení, je tak nutné s nimi dále pracovat a přikročit např. k úpravě použití daného léku, rozšíření informací pro pacienty a zdravotníky. V nejzávažnějších případech může být přikročeno až ke zrušení registračního rozhodnutí.

Držitelé rozhodnutí o registraci u léků vázaných na lékařský předpis mohou po registraci žádat o stanovení ceny a úhrady ze zdravotního pojištění. Tento krok tak přispívá ke zvýšení dostupnosti léčby, která u závažných nebo vzácných onemocnění může být velmi nákladná.

Podání či nepodání žádosti o cenu a úhradu ze zdravotního pojištění je u těchto léků pouze na rozhodnutí držitele registrace.

Cestu od laboratoře k pacientům v rámci EU popisuje i brožura Evropské lékové agentury.

Zdroje informací: SÚKL, EMA

Společnost Pharmeca a.s. připravuje články zaměřující se na základní pojmy z oblasti léků s cílem zvýšení všeobecného povědomí o dané problematice. S konkrétními dotazy je nutné se obrátit na informační středisko SÚKL.

Medicines Pharmeca info Základní pojmy - léky

Cesta léku

Objevením účinné látky začíná dlouhý proces ověřování vhodnosti a bezpečnosti léku před jeho uvedením na trh. Proces sledování u léků však nekončí ani úspěšnou registrací.

Pharmeca a.s. 04/17/2023

min

Information for MAH Medicines State Institute for Drug Control Pharmeca info

The impact of appeal decisions on decision-making practice

As of 1 April 2023, Pharmeca a.s. offers on its website a new perspective on the decisions of the Ministry of Health of the Czech Republic in appeal proceedings in the area of pricing and reimbursement of medicines.

Pharmeca a.s. 04/01/2023

min

Pharmeca a.s. provides services in the areas defined by this legislative framework:

Act No. 48/1997 Coll., on Public Health Insurance and on Amendments to Some Related Acts, as amended.

Implementing legislations:

Decree No. 376/2011 Coll., which implements certain provisions of the Public Health Insurance Act, as amended,
Decree No 384/2007 Coll., on the list of reference groups, as amended,
Decree No 385/2007 Coll., on the list of active substances for adjunct or add-on therapy;
Decree No. 618/2006 Coll., which issues framework agreements, as amended,
Decree No. 134/1998 Coll., which issues a list of medical services with point values, as amended,
Decree No. 527/2021 Coll., on determination of the amount of reimbursement of expenses for professional acts and the method of determination of the amount of compensation of expenses for professional consultations carried out by the State Institute for Drug Control under the Public Health Insurance Act, as amended,
Decree on the determination of point values, the amount of payments for paid services and regulatory restrictions - always issued for the current year,
Government Regulation No. 307/2012 Coll., on local and temporal availability of health services, as amended.

Act No. 551/1991 Coll., on the General Health Insurance Company of the Czech Republic, as amended.

Act No. 280/1992 Coll., on departmental, branch, corporate and other insurance companies, as amended.

Act No. 592/1992 Coll., on public health insurance premiums, as amended.

Implementing legislations:

Decree No. 351/2022 Coll., on the transmission of data on the consumption of medicinal products by insured persons of the public health insurance when changing the health insurance company, as amended

Act No. 526/1990 Coll., on Prices, as amended.

Act No. 378/2007 Coll., on Pharmaceuticals, as amended.

Implementing legislations:

Decree No. 228/2008 Coll., on the marketing authorisation of medicinal products, as amended,
Decree No. 84/2008 Coll., on good pharmaceutical practice, detailed conditions of handling pharmaceuticals in pharmacies, healthcare facilities and other operators and facilities supplying medicinal products, as amended,
Decree No. 85/2008 Coll., which lays down a list of active substances and excipients which may be used in the preparation of medicinal products, as amended,
Decree No 226/2008 Coll., on good clinical practice and detailed conditions of clinical trials on medicinal products, as amended,
Decree No. 228/2008 Coll., on the marketing authorisation of medicinal products, as amended,
Decree No. 229/2008 Coll., on the manufacture and distribution of pharmaceuticals, as amended,
Decree No. 236/2015 Coll., on the determination of conditions for prescription, preparation, distribution, dispense and use of individually prepared medicinal products containing cannabis for medical use, as amended,
Decree No. 329/2019 Coll., on prescribing medicinal products in the provision of health services, as amended,
Decree No. 463/2021 Coll., on the detailed conditions for conducting a clinical trial of medicinal products for human use, as amended.

Act No 167/1998 Coll, on addictive substances and amending certain other acts, as amended

Implementing legislations:

Decree No. 53/2014 Coll., on forms under the Addictive Substances Act, as amended,
Decree No. 123/2006 Coll., on evidence and documentation of addictive substances and preparations, as amended,
Decree No. 243/2009 Coll., on establishing a list of persons indicating their workplaces for their work is not required permit to treatment of addictive substances and preparations containing them, as amended,
Government Regulation No. 463/2013 Coll., on lists of addictive substances, as amended,
Decree No. 235/2022 Coll., on the cultivation and processing of cannabis plants for medicinal use, as amended,
Decree No 53/2022 Coll., on the determination of the amount of compensation of expenses for professional acts performed by the State Institute for Drug Control pursuant to the Act on Addictive Substances, as amended.

Act No. 375/2022 Coll., on medical devices and in vitro diagnostic medical devices, as amended.

Implementing legislations:

Decree No 377/2022 Coll., on the implementation of certain provisions of the Act on medical devices and in vitro diagnostic medical devices, as amended,
Decree No 379/2022 Coll., on the determination of the amount of compensation of expenses for professional acts performed by the State Institute for Drug Control pursuant to the Act on Medical Devices and In Vitro Diagnostic Medical Devices, as amended.

Act No 376/2022 Coll. amending certain acts in connection with the adoption of the Act on medical devices and in vitro diagnostic medical devices, as amended.

Act No. 268/2014 Coll., on medical devices and amending Act No. 634/2004 Coll., on administrative fees, as amended.

Act No. 89/2021 Coll., on medical devices and amending Act No. 378/2007 Coll., on pharmaceuticals and on amendments to certain related acts (Act on pharmaceuticals), as amended.

Act No. 22/1997 Coll., on Technical Requirements for Products and amendments to some related acts, as amended.

Act No. 90/2016 Coll., on the assessment of the conformity of specified products when they are placed on the market, as amended.

Act No. 372/2011 Coll., on health services and conditions for their provision (the Health Services Act), as amended.

Decree No. 373/2016 Coll., on the transfer of data to the National Health Information System, as amended.

Act No. 40/1995 Coll., on the regulation of advertising and on amending and supplementing Act No. 468/1991 Coll., on the operation of radio and television broadcasting, as amended.

Act No 242/2022 Coll., on the services of video sharing platforms and amending certain related acts (Act on the services of video sharing platforms), as amended.

Act No. 500/2004 Coll., Administrative Code, as amended.

Current price decisions, opinions and methodological instructions or regulations of the Ministry of Health of the Czech Republic.

Instructions and methodologies of SÚKL.

Information for MAH Pharmeca info Medicines Medical devices

Czech legislation

Current overview of selected Czech legal regulations regarding medicines and medical devices.

Pharmeca 02/13/2023

min

Pharmeca a.s. provides services in the areas defined by this legislative framework:

Act No. 48/1997 Coll., on Public Health Insurance and on Amendments to Some Related Acts, as amended.

Implementing legislations:

Decree No. 376/2011 Coll., which implements certain provisions of the Public Health Insurance Act, as amended,
Decree No 384/2007 Coll., on the list of reference groups, as amended,
Decree No 385/2007 Coll., on the list of active substances for adjunct or add-on therapy;
Decree No. 63/2007 Coll., on reimbursement of medicines and foodstuffs for special medical purposes, as amended,
Decree No. 618/2006 Coll., which issues framework agreements, as amended,
Decree No. 134/1998 Coll., which issues a list of medical services with point values, as amended,
Decree on the determination of point values, the amount of payments for paid services and regulatory restrictions - always issued for the current year.

Act No. 551/1991 Coll., on the General Health Insurance Company of the Czech Republic, as amended.

Act No. 280/1992 Coll., on departmental, branch, corporate and other insurance companies, as amended.

Act No. 592/1992 Coll., on public health insurance premiums, as amended.

Act No. 526/1990 Coll., on Prices, as amended.

Act No. 378/2007 Coll., on Pharmaceuticals, as amended.

Implementing legislations:

Decree No. 228/2008 Coll., on the marketing authorisation of medicinal products, as amended,
Decree No. 54/2008 Coll., on the method of prescribing medicinal products, particulars to appear on medical prescriptions, and rules governing the use of medical prescriptions, as amended,
Decree No. 84/2008 Coll., on good pharmaceutical practice, detailed conditions of handling pharmaceuticals in pharmacies, healthcare facilities and other operators and facilities supplying medicinal products, as amended,
Decree No. 85/2008 Coll., which lays down a list of active substances and excipients which may be used in the preparation of medicinal products, as amended,
Decree No 226/2008 Coll., on good clinical practice and detailed conditions of clinical trials on medicinal products, as amended,
Decree No. 228/2008 Coll., on the marketing authorisation of medicinal products, as amended,
Decree No. 229/2008 Coll., on the manufacture and distribution of pharmaceuticals, as amended,
Decree No. 236/2015 Coll., on the determination of conditions for prescription, preparation, distribution, dispense and use of individually prepared medicinal products containing cannabis for medical use, as amended,
Decree No. 415/2017 Coll., on the implementation of certain provisions of the Act on Medicinal Products relating to electronic prescriptions, as amended,
Decree No. 329/2019 Coll., on prescribing medicinal products in the provision of health services, as amended.

Act No 167/1998 Coll, on addictive substances and amending certain other acts, as amended

Implementing legislations:

Decree No. 123/2006 Coll., on evidence and documentation of addictive substances and preparations, as amended,
Decree No. 243/2009 Coll., on establishing a list of persons indicating their workplaces for their work is not required permit to treatment of addictive substances and preparations containing them, as amended,
Government Regulation No. 463/2013 Coll., on lists of addictive substances, as amended.

Act No. 268/2014 Coll., on medical devices and amending Act No. 634/2004 Coll., on administrative fees, as amended,

Implementing legislations:

Decree No. 62/2015 Coll., on the implementation of certain provisions of the Medical Devices Act, as amended,
Government Regulation No. 56/2015 Coll., on technical requirements for in vitro diagnostic medical devices,
Government Regulation No. 55/2015 Coll., on technical requirements for active implantable medical devices,
Government Regulation No. 54/2015 Coll., on technical requirements for medical devices.

Act No. 22/1997 Coll., on Technical Requirements for Products and amendments to some related acts, as amended.

Act No. 90/2016 Coll., on the assessment of the conformity of specified products when they are placed on the market, as amended.

Act No. 372/2011 Coll., on health services and conditions for their provision (the Health Services Act), as amended.

Decree No. 373/2016 Coll., on the transfer of data to the National Health Information System, as amended.

Act No. 500/2004 Coll., Administrative Code, as amended.

Current price decisions, opinions and methodological instructions or regulations of the Ministry of Health of the Czech Republic.

Instructions and methodologies of SÚKL.

Information for MAH Pharmeca info Medicines Medical devices

Important sources of legislative information

An up-to-date overview of legislative resources regarding medicines and medical devices, which Pharmeca a.s. uses within the provided services.

Pharmeca 01/02/2022

min

Pharmeca a.s. provides services in the areas defined by this legislative framework:

Act No. 48/1997 Coll., on Public Health Insurance and on Amendments to Some Related Acts, as amended.

Implementing legislations:

Decree No. 376/2011 Coll., which implements certain provisions of the Public Health Insurance Act, as amended,
Decree No 384/2007 Coll., on the list of reference groups, as amended,
Decree No 385/2007 Coll., on the list of active substances for adjunct or add-on therapy;
Decree No. 63/2007 Coll., on reimbursement of medicines and foodstuffs for special medical purposes, as amended,
Decree No. 618/2006 Coll., which issues framework agreements, as amended,
Decree No. 134/1998 Coll., which issues a list of medical services with point values, as amended,
Decree on the determination of point values, the amount of payments for paid services and regulatory restrictions - always issued for the current year.

Act No. 551/1991 Coll., on the General Health Insurance Company of the Czech Republic, as amended.

Act No. 280/1992 Coll., on departmental, branch, corporate and other insurance companies, as amended.

Act No. 592/1992 Coll., on public health insurance premiums, as amended.

Act No. 526/1990 Coll., on Prices, as amended.

Act No. 378/2007 Coll., on Pharmaceuticals, as amended.

Implementing legislations:

Decree No. 228/2008 Coll., on the marketing authorisation of medicinal products, as amended,
Decree No. 54/2008 Coll., on the method of prescribing medicinal products, particulars to appear on medical prescriptions, and rules governing the use of medical prescriptions, as amended,
Decree No. 84/2008 Coll., on good pharmaceutical practice, detailed conditions of handling pharmaceuticals in pharmacies, healthcare facilities and other operators and facilities supplying medicinal products, as amended,
Decree No. 85/2008 Coll., which lays down a list of active substances and excipients which may be used in the preparation of medicinal products, as amended,
Decree No 226/2008 Coll., on good clinical practice and detailed conditions of clinical trials on medicinal products, as amended,
Decree No. 228/2008 Coll., on the marketing authorisation of medicinal products, as amended,
Decree No. 229/2008 Coll., on the manufacture and distribution of pharmaceuticals, as amended,
Decree No. 236/2015 Coll., on the determination of conditions for prescription, preparation, distribution, dispense and use of individually prepared medicinal products containing cannabis for medical use, as amended,
Decree No. 415/2017 Coll., on the implementation of certain provisions of the Act on Medicinal Products relating to electronic prescriptions, as amended,
Decree No. 329/2019 Coll., on prescribing medicinal products in the provision of health services, as amended.

Act No 167/1998 Coll, on addictive substances and amending certain other acts, as amended

Implementing legislations:

Decree No. 123/2006 Coll., on evidence and documentation of addictive substances and preparations, as amended,
Decree No. 243/2009 Coll., on establishing a list of persons indicating their workplaces for their work is not required permit to treatment of addictive substances and preparations containing them, as amended,
Government Regulation No. 463/2013 Coll., on lists of addictive substances, as amended.

Act No. 268/2014 Coll., on medical devices and amending Act No. 634/2004 Coll., on administrative fees, as amended,

Implementing legislations:

Decree No. 62/2015 Coll., on the implementation of certain provisions of the Medical Devices Act, as amended,
Government Regulation No. 56/2015 Coll., on technical requirements for in vitro diagnostic medical devices,
Government Regulation No. 55/2015 Coll., on technical requirements for active implantable medical devices,
Government Regulation No. 54/2015 Coll., on technical requirements for medical devices.

Act No. 22/1997 Coll., on Technical Requirements for Products and amendments to some related acts, as amended.

Act No. 90/2016 Coll., on the assessment of the conformity of specified products when they are placed on the market, as amended.

Act No. 372/2011 Coll., on health services and conditions for their provision (the Health Services Act), as amended.

Decree No. 373/2016 Coll., on the transfer of data to the National Health Information System, as amended.

Act No. 500/2004 Coll., Administrative Code, as amended.

Current price decisions, opinions and methodological instructions or regulations of the Ministry of Health of the Czech Republic.

Instructions and methodologies of SÚKL.

Information for MAH Pharmeca info Medicines Medical devices

Important sources of legislative information

An up-to-date overview of legislative resources regarding medicines and medical devices, which Pharmeca a.s. uses within the provided services.

Pharmeca 01/05/2021

Pharmeca.cz

News

Save the date: EMA organizuje Information Day for CTIS 17. října 2024

Clinical Trials Information System (CTIS) - present and future

Change in VAT Rates for Medicines

Cesta léku

The impact of appeal decisions on decision-making practice

Czech legislation

Important sources of legislative information

Important sources of legislative information

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