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1 year ago

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4.2.1. - cerliponase

4.2.1. - cerliponase alfa - EMA/OD/177/12, EU/3/13/1118, EMEA/H/C/004065 ......................... 24 4.2.2. - parathyroid hormone – EMA/OD/102/13, EU/3/13/1210, EMEA/H/C/003861 ................ 24 4.2.3. - pentosan polysulfate sodium – EMA/OD/179/14, EU/3/14/1411, EMEA/H/C/004246 ...... 24 4.3. Appeal .................................................................................................................. 25 4.4. On-going procedures ............................................................................................ 25 4.5. Public Summary of Opinions ................................................................................. 25 5. Review of orphan designation for authorised orphan medicinal products at time marketing authorisation extension 25 5.1. After adoption of CHMP opinion ............................................................................ 25 5.2. Prior to adoption of CHMP opinion ........................................................................ 25 5.3. Appeal .................................................................................................................. 25 6. Application of Article 8(2) of the Orphan Regulation 25 7. Organisational, regulatory and methodological matters 25 7.1. Mandate and organisation of the COMP ................................................................ 25 7.1.1. Protocol Assistance Working Group ............................................................................ 25 7.1.2. Strategic Review & Learning meetings ........................................................................ 25 7.1.3. Survey to Committee members, alternates and concerned NCA staff on the service and support provided by EMA Committee Secretariats - Findings ......................................... 26 7.1.4. Selection procedure for COMP members nominated by the EC on EMA recommendation ... 26 7.2. Coordination with EMA Scientific Committees or CMDh-v ..................................... 26 7.2.1. PDCO/COMP Working Group ...................................................................................... 26 7.2.2. Recommendations on eligibility to PRIME – report from CHMP ....................................... 26 7.3. Coordination with EMA Working Parties/Working Groups/Drafting Groups ......... 26 7.4. Cooperation within the EU regulatory network ..................................................... 26 7.4.1. European Commission .............................................................................................. 26 7.5. Cooperation with International Regulators ........................................................... 26 7.5.1. Food and Drug Administration (FDA) .......................................................................... 26 7.5.2. Japanese Pharmaceuticals and Medical Devices Agency (PMDA) ..................................... 26 7.5.3. The Therapeutic Goods Administration (TGA), Australia ................................................ 26 7.5.4. Health Canada......................................................................................................... 27 7.6. Contacts of the COMP with external parties and interaction with the Interested Parties to the Committee ...................................................................................... 27 7.7. COMP work plan ................................................................................................... 27 7.7.1. COMP Work Plan 2017 .............................................................................................. 27 7.8. Planning and reporting ......................................................................................... 27 7.8.1. List of all applications submitted/expected and the COMP coordinatorship distribution of valid applications submitted in 2017 .......................................................................... 27 7.8.2. Overview of orphan marketing authorisations/applications ............................................ 27 Committee for Orphan Medicinal Products (COMP) EMA/COMP/50377/2017 Page 4/28

8. Any other business 27 8.1. - ............................................................................................................................ 27 9. Explanatory notes 27 Committee for Orphan Medicinal Products (COMP) EMA/COMP/50377/2017 Page 5/28

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