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Support for industry on clinical data publication

NEWS FLASH


Support for industry on clinical data publication

The European Medicines Agency (EMA) has developed detailed guidance for pharmaceutical companies on the requirements to comply with its policy on the publication of clinical data.

 

Temporary submission timelines (New)

Submission timelines outlined in the external guidance are currently not applicable. The Agency is processing procedures in chronological order of their Committee for Human Medicinal Products (CHMP) opinion or withdrawal date. 

EMA will send companies invitation letters 6 months in advance of the requested submission date. 

As of March 2018, EMA is processing procedures adopted by the CHMP in the fourth quarter of 2016.

Guidance and templates

EMA first published guidance in March 2016 and is updating it on a regular basis. Current and past versions of the guidance as well as the list of changes between published versions can be found below:

The external guidance provides further information on: 

  • the scope of the policy as regards clinical reports submitted as part of other regulatory procedures, informed consent applications and duplicate marketing authorisations, as well as definitions (in chapter 1);
  • the procedural aspects related to the submission of clinical reports (in chapter 2);
  • anonymising clinical reports (in chapter 3), including a template for the anonymisation report (in annex 1.2);
  • how to identify and redact commercially confidential information in clinical reports (in chapter 4).

Companies should provide justifications for redactions of commercially confidential information by using the following template:

EMA has developed a questions-and-answers (Q&A) document to expand on issues addressed in the external guidance and in discussions with applicants. It addresses a number of questions concerning procedural matters including timelines, commercially confidential information and the anonymisation process. For more information, see:

It will be revised regularly to reflect updates.

Stakeholder meetings

EMA also held a series of briefings and consultations to support stakeholders in implementing the policy:

Agendas, meeting reports, presentations, question-and-answer documents and available video recordings are provided on the meeting pages.

Micro, small and medium-sized enterprises

Micro, small and medium-sized enterprises (SMEs) are entitled to a free redaction tool license valid for a period of 12 months to allow companies enough time to prepare the final redacted version. The application letter template for the free redaction tool is available in annex 1 of the external guidance.  

SMEs should contact the SME office 5 months prior to the CHMP opinion to apply for the free redaction tool license. The SME office can also provide further guidance on the EMA's policy on the publication of clinical data.

 

This article was originally posted on the EMA website

Archives

To view posts from prior years, click the link below.

Annual Archive

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NEWS FLASH


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The European Medicines Agency (EMA) has developed detailed guidance for pharmaceutical companies on the requirements to comply with its policy on the publication of clinical data.

 

Temporary submission timelines (New)

Submission timelines outlined in the external guidance are currently not applicable. The Agency is processing procedures in chronological order of their Committee for Human Medicinal Products (CHMP) opinion or withdrawal date. 

EMA will send companies invitation letters 6 months in advance of the requested submission date. 

As of March 2018, EMA is processing procedures adopted by the CHMP in the fourth quarter of 2016.

Guidance and templates

EMA first published guidance in March 2016 and is updating it on a regular basis. Current and past versions of the guidance as well as the list of changes between published versions can be found below:

The external guidance provides further information on: 

  • the scope of the policy as regards clinical reports submitted as part of other regulatory procedures, informed consent applications and duplicate marketing authorisations, as well as definitions (in chapter 1);
  • the procedural aspects related to the submission of clinical reports (in chapter 2);
  • anonymising clinical reports (in chapter 3), including a template for the anonymisation report (in annex 1.2);
  • how to identify and redact commercially confidential information in clinical reports (in chapter 4).

Companies should provide justifications for redactions of commercially confidential information by using the following template:

EMA has developed a questions-and-answers (Q&A) document to expand on issues addressed in the external guidance and in discussions with applicants. It addresses a number of questions concerning procedural matters including timelines, commercially confidential information and the anonymisation process. For more information, see:

It will be revised regularly to reflect updates.

Stakeholder meetings

EMA also held a series of briefings and consultations to support stakeholders in implementing the policy:

Agendas, meeting reports, presentations, question-and-answer documents and available video recordings are provided on the meeting pages.

Micro, small and medium-sized enterprises

Micro, small and medium-sized enterprises (SMEs) are entitled to a free redaction tool license valid for a period of 12 months to allow companies enough time to prepare the final redacted version. The application letter template for the free redaction tool is available in annex 1 of the external guidance.  

SMEs should contact the SME office 5 months prior to the CHMP opinion to apply for the free redaction tool license. The SME office can also provide further guidance on the EMA's policy on the publication of clinical data.

 

This article was originally posted on the EMA website

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Archives


To view posts from prior years, click the link below.

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