RadDG Work plan 2017 - European Medicines Agency - Europa EU

15 December 2016 EMA/CHMP/816669/2016

Work plan for the Radiopharmaceutical Drafting Group for 2017

Chairperson: Anabel Cortes Blanco Status of the work plan: Adopted in December 2016

1. Meetings scheduled for 2017 Face-to-face meetings are planned for the following dates: 

18 September 2017

Virtual meetings are planned for the following dates: 

20 January 2017



26 April 2017



19 May 2017



27 July 2017



16 November 2017

Virtual meetings/web sharing will be planned to accommodate scientific input to products scientific advice and evaluation. Additional teleconferences will be organised ad-hoc to respond to time-sensitive input on products and to progress guidelines, as required.

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© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.

2. Guidelines 2.1. New EU Guidelines Action: Lead

Core SmPC and PL for technetium (99mTc) HDP and (99mTc) MDP Target date

Q1 2017

Comments

New guideline for external consultation

Core SmPC and package leaflet for technetium (99mTc) medronate Target date

Q1 2017

Comments


Core SmPC and package leaflet for technetium (99mTc) macrosalb Target date

Q1 2017

Comments


Core SmPC and package leaflet for iobenguane (123I) Target date

Q2 2017

Comments


Core SmPC and package leaflet for sodium iodide (131I) therapy capsules Target date

Q2 2017

Comments

New guideline under external consultation

Core SmPC and package leaflet for iopamidol 300/370 mg I/ml Target date

Q2 2017

Comments


Core SmPC and package leaflet for technetium (99mTc) exametazime Target date

Q2 2017

Comments


Core SmPC and PIL of lutetium (177Lu) chloride Target date

Q2 2017

Comments


Core SmPC and PIL of fluorocholine (18F) Target date

Q2 2017

Work plan for the Radiopharmaceutical Drafting Group for 2017 EMA/CHMP/633868/2016

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Comments


Core SmPC and package leaflet for gadopentetate dimeglumine Target date

Q4 2017

Comments

New guideline under review following external consultation

Core SmPC and package leaflet for (68Ge/68Ga) generator Target date

Q4 2017

Comments

New guideline under review following external consultation

Core SmPC and package leaflet for fluorodopa (18F) Target date Comments

Q4 2017 New guideline under review following external consultation

Core SmPC and package leaflet for gadoteric acid Target date Comments

Q4 2017 New guideline under review following external consultation

Action: Specialised input Draft annex for harmonisation of wording on safety information in the core SmPC/PL of iodinated contrast agents. Target date

2Q 2017

Comments

In consultation with the SmPC advisory group, the RadDG will prepare an annex to harmonise class-related safety information aspects for core SmPCs of iodinated contrast agents. This annex will be released with the core SmPC and PL for iopamidol 300.

Draft annex for harmonisation of wording on safety information in the core SmPC/PL of Gadoliniumbased contrast agents. Target date

2Q 2017

Comments

In consultation with the SmPC advisory group, the RadDG will prepare an annex to the SmPC for Gadolinium-based contrast agents to harmonise class-related safety information aspects for core SmPCs of Gadolinium-based contrast agents.

2.2. EU Guidelines under revision Action: Lead Core SmPC and Package Leaflet for Radiopharmaceuticals, EMA/CHMP/167834/2011


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Target date

Q1 2017

Comments

Revised guideline for external consultation

Action: Specialised input None

2.3. ICH Guidelines None

3. Medicinal Products-specific activities 3.1. Pre-Authorisation activities None

3.2. Evaluation and supervision activities None

4. Input in European activities 4.1. Training for the network and knowledge building None

5. Input in International activities (beyond ICH guidelines) None

6. Contribution to dialogue and engagement with stakeholders and external parties 6.1. Workshops None


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