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BNT162b2 Zulassungsverfahren: Ablauf, Inhalte, Bewertungsmaßstäbe, Bewertung von Studienmängeln

den zeitlichen Ablauf und alle Inhalte des Zulassungsverfahrens BNT162b2,
wie und wann die Behörde Zwischenergebnisse der im Rahmen des Zulassungsverfahrens herangezogenen Hersteller-Studien bewertet hat sowie den jeweiligen Maßstab der Bewertung,
welche herstellerfremden wissenschaftlichen Erkenntnisse für das Zulassungsverfahren genutzt wurden,
wie die Behörde fehlende Doppelverblindungen in Studien des Herstellers in Bezug auf die Qualität und Gültigkeit der entsprechenden Studienergebnisse bewertet hat.

Anfrage wurde zurückgezogen

  • Datum
    24. November 2021
  • Frist
    15. Dezember 2021
  • 0 Follower:innen
<< Anfragesteller:in >>
Antrag nach EU-Verordnungen 1049/2001 sowie 1367/2006 Sehr geehrte Damen und Herren, auf Basis der Verordnungen 1…
An Europäische Arzneimittel-Agentur Details
Von
<< Anfragesteller:in >>
Betreff
BNT162b2 Zulassungsverfahren: Ablauf, Inhalte, Bewertungsmaßstäbe, Bewertung von Studienmängeln [#233664]
Datum
24. November 2021 10:55
An
Europäische Arzneimittel-Agentur
Status
Warte auf Antwort — E-Mail wurde erfolgreich versendet.
Antrag nach EU-Verordnungen 1049/2001 sowie 1367/2006 Sehr geehrte Damen und Herren, auf Basis der Verordnungen 1049/2001 sowie 1367/2006 bitte ich Sie um Übersendung von Dokumenten, die folgende Informationen enthalten:
den zeitlichen Ablauf und alle Inhalte des Zulassungsverfahrens BNT162b2, wie und wann die Behörde Zwischenergebnisse der im Rahmen des Zulassungsverfahrens herangezogenen Hersteller-Studien bewertet hat sowie den jeweiligen Maßstab der Bewertung, welche herstellerfremden wissenschaftlichen Erkenntnisse für das Zulassungsverfahren genutzt wurden, wie die Behörde fehlende Doppelverblindungen in Studien des Herstellers in Bezug auf die Qualität und Gültigkeit der entsprechenden Studienergebnisse bewertet hat.
Ich weise ausdrücklich darauf hin, dass ich eine Antwort per E-Mail an diese Adresse und nicht über ein Webportal wünsche. Ich möchte Sie um eine Empfangsbestätigung bitten und danke Ihnen für Ihre Mühe! Mit freundlichen Grüßen Antragsteller/in Antragsteller/in Anfragenr: 233664 Antwort an: <<E-Mail-Adresse>> Laden Sie große Dateien zu dieser Anfrage hier hoch: https://fragdenstaat.de/a/233664/ Postanschrift Antragsteller/in Antragsteller/in << Adresse entfernt >>
Mit freundlichen Grüßen << Anfragesteller:in >>
Europäische Arzneimittel-Agentur
Dear Sir/Madam **ASK-101026 - (VY) BNT162b2 Zulassungsverfahren: Ablauf, Inhalte, Bewertungsmaßstäbe, Bewertung v…
Von
Europäische Arzneimittel-Agentur
Betreff
AskEMA - Acknowledgement to ASK-101026 - (VY) BNT162b2 Zulassungsverfahren: Ablauf, Inhalte, Bewertungsmaßstäbe, Bewertung von Studienmängeln [#233664]
Datum
25. November 2021 16:18
Status
Anfrage abgeschlossen
Dear Sir/Madam **ASK-101026 - (VY) BNT162b2 Zulassungsverfahren: Ablauf, Inhalte, Bewertungsmaßstäbe, Bewertung von Studienmängeln [#233664] received on 25/11/2021** Thank you for submitting your request. This is an automated response to confirm that we have received your request; please do not respond directly to this message as this email address is not monitored. A member of Agency staff will now review your request. We will send an acknowledgement of receipt to the email address you have provided, quoting your unique reference number. We endeavour to review all requests as soon as possible, but no later than within 48 hours of receipt, during our normal business hours (see Business hours and holidays). Should you need to contact us in relation to this request please submit your updated query through the webform, quoting the ASK reference number given above. Kind regards, **European Medicines Agency** Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands Send us a question. Go towww.ema.europa.eu/contact ( http:://www.ema.europa.eu/contact ) Telephone: +31 (0)88 781 6000 ____________________________________________________________ We received your question(s) on: **25/11/2021** Subject of your enquiry: **(VY) BNT162b2 Zulassungsverfahren: Ablauf, Inhalte, Bewertungsmaßstäbe, Bewertung von Studienmängeln [#233664]** Your question(s): **
Europäische Arzneimittel-Agentur
Clarification needed - Comirnaty - ASK-101026 Dear Mr. Antragsteller/in, Thank you for your request for access to…
Von
Europäische Arzneimittel-Agentur
Betreff
Clarification needed - Comirnaty - ASK-101026
Datum
26. November 2021 12:48
Status
Warte auf Antwort
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Dear Mr. Antragsteller/in, Thank you for your request for access to documents. Your application was registered with the number ASK-101026. We would like to inform you that the working language in the agency is English and therefore all working documents are in English. The documents you have requested are also only available in English. The decision about your access to documents application will be issued in English as it is part of an official process. Your request regarding the approval documents of Comirnaty (COVID-19 mRNA vaccine (nucleoside-modified)) is too extensive and not clear enough and we have to clarify with you which exact documents you would like to apply for. I would like to draw your attention to the relevant European Public Assessment Reports (EPAR) which give you information on the evaluation of the product and that data it was evaluated on. The EPAR provides a summary of the grounds for a Committee opinion in favour of granting or refusing a marketing authorisation for a specific medicinal product. It results from the Committee's review of the documentation submitted by the applicant, and from subsequent discussions held during Committee meetings. EPAR also contain a summary written in a manner that is understandable to the public. EPAR can be also consulted online on the Agency’s website: https://www.ema.europa.eu/en/documents/assessment-report/comirnaty-epar-public-assessment-report_en.pdf I would also invite you to consult the “Procedural steps taken and scientific information after the authorisation” in which you can find all variations to the Marketing Authorisation: https://www.ema.europa.eu/en/documents/procedural-steps-after/comirnaty-epar-procedural-steps-taken-scientific-information-after-authorisation_en.pdf Please also note that EMA is currently operating under business continuity measures to ensure its operational continuity during the COVID-19 pandemic. Whilst every effort is being made to process all access to documents requests as soon as possible, due to these exceptional circumstances and in order to ensure a manageable flow of all access-to-documents requests from all requesters in a fair, timely and consistent way, the following approach is applied: • Each access to documents request cannot exceed 2 documents • A requester/affiliation can have a maximum of 5 access to documents requests in queue. You can find more information about this in the ‘Guidance on unpublished documents’ at our website ( https://www.ema.europa.eu/en/documents/other/guide-access-unpublished-documents_en.pdf ), specifically Questions 17 and 18. Based on the above, we kindly ask you to indicate exactly what are the two documents you are interested in. We would appreciate your feedback by Friday 3rd December. Kind Regards,
<< Anfragesteller:in >>
AW: Clarification needed - Comirnaty - ASK-101026 [#233664] Sehr geehrte Damen und Herren, danke für Ihre Antwort…
An Europäische Arzneimittel-Agentur Details
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<< Anfragesteller:in >>
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AW: Clarification needed - Comirnaty - ASK-101026 [#233664]
Datum
13. Dezember 2021 14:16
An
Europäische Arzneimittel-Agentur
Status
E-Mail wurde erfolgreich versendet.
Sehr geehrte Damen und Herren, danke für Ihre Antwort. Bitte senden Sie mir die Dokumente, die Aufschluss darüber geben, wie die fehlende Doppelverblindungen in Studien des Herstellers in Bezug auf die Qualität und Gültigkeit der entsprechenden Studienergebnisse von Ihrer Behörde bewertet wurden. Da ich natürlich nicht wissen kann, in welcher Form diese Bewertungen festgehalten wurden, bitte ich Sie, die entsprechenden Dokumente selbst zu ermitteln (Korrespondenz, Experten-Stellungnahmen o.ä.). Bitte teilen Sie mir mit, ob und welche Kosten hierfür entstehen. Mit freundlichen Grüßen Antragsteller/in Antragsteller/in Anfragenr: 233664 Antwort an: <<E-Mail-Adresse>> Laden Sie große Dateien zu dieser Anfrage hier hoch: https://fragdenstaat.de/a/233664/ Postanschrift Antragsteller/in Antragsteller/in << Adresse entfernt >>
Europäische Arzneimittel-Agentur
RE: Clarification needed - Comirnaty - ASK-101026 [#233664]
Dear Mr. Antragsteller/in, Thank you for your follow…
Von
Europäische Arzneimittel-Agentur
Betreff
RE: Clarification needed - Comirnaty - ASK-101026 [#233664]
Datum
17. Dezember 2021 11:08
Status
Anfrage abgeschlossen
Dear Mr. Antragsteller/in, Thank you for your follow up e-mail, however please note that the scope of your request is still not clear to us. We would like to reiterate that on the EPAR you can find an overview of the benefit risk assessment and of the pivotal studies. For a tabular overview of clinical studies please refer to page 57, for the summary of main study please refer to page 90 and for the discussion on clinical efficacy please refer to page 92: https://www.ema.europa.eu/en/document... Moreover, we am sending you the link to the structure of the Marketing Authorisation dossier for your attention, which give you more information about the structure of the dossiers and the information we hold on the products. The data submitted by medicine developers in their application for marketing authorisation must include a range of information, including information on the way the medicine is manufactured, its effects in laboratory studies, benefits and side effects observed in patients, and how risks will be managed, as well as the proposed information to be provided to patients and doctors. The information mentioned above is structured in 5 modules (modules 1-5) with a number of sub-modules. For a quick overview please refer to page 10 and 26: https://ec.europa.eu/health/sites/hea... Furthermore, please note that in line with its exceptional transparency measures for treatments and vaccines for COVID-19 some of the clinical data submitted in the application in module 5 have already been published by EMA for all four vaccines on the following website: https://clinicaldata.ema.europa.eu/we... Please note that you will need to create an account (to register) in the system before you can view or download the document if you do not already have an EMA account. You have to create a researcher account if you wish to download the document. The general account would only allow you to see the document on screen. Finally, please also note that EMA is currently operating under business continuity measures to ensure its operational continuity during the COVID-19 pandemic. Whilst every effort is being made to process all access to documents requests as soon as possible, due to these exceptional circumstances and in order to ensure a manageable flow of all access-to-documents requests from all requesters in a fair, timely and consistent way, the following approach is applied: • Each access to documents request cannot exceed 2 documents • A requester/affiliation can have a maximum of 5 access to documents requests in queue. You can find more information about this in the ‘Guidance on unpublished documents’ at our website ( https://www.ema.europa.eu/en/document... ), specifically Questions 17 and 18. Please note that in the above mentioned Question 18 of the guidance document you will find more detailed information on what is considered as one document. This information should help you identifying the requested documents Based on the above, we kindly ask you to indicate exactly the two documents you are interested in. Thank you for considering the above Kind Regards, Documents Access and Publication Service Stakeholders and Communication Division European Medicines Agency Domenico Scarlattilaan 6 | 1083 HS Amsterdam | The Netherlands | www.ema.europa.eu
Europäische Arzneimittel-Agentur
RE: Clarification needed - Comirnaty - ASK-101026 [#233664]
Dear Mr. Antragsteller/in, As we have not received an…
Von
Europäische Arzneimittel-Agentur
Betreff
RE: Clarification needed - Comirnaty - ASK-101026 [#233664]
Datum
20. Januar 2022 12:41
Status
Dear Mr. Antragsteller/in, As we have not received any information from you we have been unable to proceed with your request. If you would still like to receive the requested documents, please provide the requested clarification as soon as possible. If we have not received your response by 27 January 2022, we will consider your request ASK-101026 to have been withdrawn. You are, of course, very welcome to contact us again in future via our webform should you wish to request access to documents held by the European Medicines Agency. Kind regards, Documents Access and Publication Service Stakeholders and Communication Division European Medicines Agency Domenico Scarlattilaan 6 | 1083 HS Amsterdam | The Netherlands | www.ema.europa.eu<http://www.ema.europa.eu> Classified as confidential by the European Medicines Agency From: Antragsteller/in Sent: Friday, 17 December 2021 11:08 To: '<<E-Mail-Adresse>>' <<Name und E-Mail-Adresse>> Subject: RE: Clarification needed - Comirnaty - ASK-101026 [#233664] Dear Mr. Antragsteller/in, Thank you for your follow up e-mail, however please note that the scope of your request is still not clear to us. We would like to reiterate that on the EPAR you can find an overview of the benefit risk assessment and of the pivotal studies. For a tabular overview of clinical studies please refer to page 57, for the summary of main study please refer to page 90 and for the discussion on clinical efficacy please refer to page 92: https://www.ema.europa.eu/en/document... Moreover, we am sending you the link to the structure of the Marketing Authorisation dossier for your attention, which give you more information about the structure of the dossiers and the information we hold on the products. The data submitted by medicine developers in their application for marketing authorisation must include a range of information, including information on the way the medicine is manufactured, its effects in laboratory studies, benefits and side effects observed in patients, and how risks will be managed, as well as the proposed information to be provided to patients and doctors. The information mentioned above is structured in 5 modules (modules 1-5) with a number of sub-modules. For a quick overview please refer to page 10 and 26: https://ec.europa.eu/health/sites/hea... Furthermore, please note that in line with its exceptional transparency measures for treatments and vaccines for COVID-19 some of the clinical data submitted in the application in module 5 have already been published by EMA for all four vaccines on the following website: https://clinicaldata.ema.europa.eu/we... Please note that you will need to create an account (to register) in the system before you can view or download the document if you do not already have an EMA account. You have to create a researcher account if you wish to download the document. The general account would only allow you to see the document on screen. Finally, please also note that EMA is currently operating under business continuity measures to ensure its operational continuity during the COVID-19 pandemic. Whilst every effort is being made to process all access to documents requests as soon as possible, due to these exceptional circumstances and in order to ensure a manageable flow of all access-to-documents requests from all requesters in a fair, timely and consistent way, the following approach is applied: • Each access to documents request cannot exceed 2 documents • A requester/affiliation can have a maximum of 5 access to documents requests in queue. You can find more information about this in the ‘Guidance on unpublished documents’ at our website ( https://www.ema.europa.eu/en/document... ), specifically Questions 17 and 18. Please note that in the above mentioned Question 18 of the guidance document you will find more detailed information on what is considered as one document. This information should help you identifying the requested documents Based on the above, we kindly ask you to indicate exactly the two documents you are interested in. Thank you for considering the above Kind Regards, Documents Access and Publication Service Stakeholders and Communication Division European Medicines Agency Domenico Scarlattilaan 6 | 1083 HS Amsterdam | The Netherlands | www.ema.europa.eu<http://www.ema.europa.eu>

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Europäische Arzneimittel-Agentur
RE: Clarification needed - Comirnaty - ASK-101026 [#233664]
Dear Mr. Antragsteller/in, I write further to our e-m…
Von
Europäische Arzneimittel-Agentur
Betreff
RE: Clarification needed - Comirnaty - ASK-101026 [#233664]
Datum
14. Februar 2022 11:15
Status
Dear Mr. Antragsteller/in, I write further to our e-mails of 17 December 2021 and 20 January 2022 in which you were asked to provide clarifications regarding the scope of your request. As we have not received any response we consider your request to have been withdrawn. You are, of course, very welcome to contact us again in future via our webform should you wish to request access to documents held by the European Medicines Agency. Kind regards, Documents Access and Publication Service Stakeholders and Communication Division European Medicines Agency Domenico Scarlattilaan 6 | 1083 HS Amsterdam | The Netherlands | www.ema.europa.eu<http://www.ema.europa.eu> Classified as confidential by the European Medicines Agency From: Antragsteller/in Sent: Thursday, 20 January 2022 12:42 To: '<<E-Mail-Adresse>>' <<Name und E-Mail-Adresse>> Subject: RE: Clarification needed - Comirnaty - ASK-101026 [#233664] Dear Mr. Antragsteller/in, As we have not received any information from you we have been unable to proceed with your request. If you would still like to receive the requested documents, please provide the requested clarification as soon as possible. If we have not received your response by 27 January 2022, we will consider your request ASK-101026 to have been withdrawn. You are, of course, very welcome to contact us again in future via our webform should you wish to request access to documents held by the European Medicines Agency. Kind regards, Documents Access and Publication Service Stakeholders and Communication Division European Medicines Agency Domenico Scarlattilaan 6 | 1083 HS Amsterdam | The Netherlands | www.ema.europa.eu<http://www.ema.europa.eu> Classified as confidential by the European Medicines Agency From: Antragsteller/in Sent: Friday, 17 December 2021 11:08 To: '<<E-Mail-Adresse>>' <<<E-Mail-Adresse>><mailto:<<E-Mail-Adresse>>>> Subject: RE: Clarification needed - Comirnaty - ASK-101026 [#233664] Dear Mr. Antragsteller/in, Thank you for your follow up e-mail, however please note that the scope of your request is still not clear to us. We would like to reiterate that on the EPAR you can find an overview of the benefit risk assessment and of the pivotal studies. For a tabular overview of clinical studies please refer to page 57, for the summary of main study please refer to page 90 and for the discussion on clinical efficacy please refer to page 92: https://www.ema.europa.eu/en/document... Moreover, we am sending you the link to the structure of the Marketing Authorisation dossier for your attention, which give you more information about the structure of the dossiers and the information we hold on the products. The data submitted by medicine developers in their application for marketing authorisation must include a range of information, including information on the way the medicine is manufactured, its effects in laboratory studies, benefits and side effects observed in patients, and how risks will be managed, as well as the proposed information to be provided to patients and doctors. The information mentioned above is structured in 5 modules (modules 1-5) with a number of sub-modules. For a quick overview please refer to page 10 and 26: https://ec.europa.eu/health/sites/hea... Furthermore, please note that in line with its exceptional transparency measures for treatments and vaccines for COVID-19 some of the clinical data submitted in the application in module 5 have already been published by EMA for all four vaccines on the following website: https://clinicaldata.ema.europa.eu/we... Please note that you will need to create an account (to register) in the system before you can view or download the document if you do not already have an EMA account. You have to create a researcher account if you wish to download the document. The general account would only allow you to see the document on screen. Finally, please also note that EMA is currently operating under business continuity measures to ensure its operational continuity during the COVID-19 pandemic. Whilst every effort is being made to process all access to documents requests as soon as possible, due to these exceptional circumstances and in order to ensure a manageable flow of all access-to-documents requests from all requesters in a fair, timely and consistent way, the following approach is applied: • Each access to documents request cannot exceed 2 documents • A requester/affiliation can have a maximum of 5 access to documents requests in queue. You can find more information about this in the ‘Guidance on unpublished documents’ at our website ( https://www.ema.europa.eu/en/document... ), specifically Questions 17 and 18. Please note that in the above mentioned Question 18 of the guidance document you will find more detailed information on what is considered as one document. This information should help you identifying the requested documents Based on the above, we kindly ask you to indicate exactly the two documents you are interested in. Thank you for considering the above Kind Regards, Documents Access and Publication Service Stakeholders and Communication Division European Medicines Agency Domenico Scarlattilaan 6 | 1083 HS Amsterdam | The Netherlands | www.ema.europa.eu<http://www.ema.europa.eu>