1. Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbHwww.ages.at ASMF-AR – database ad-hoc group on ASMF assessment Christa Wirthumer-Hoche Vienna, AT 28 April 2011 HMA-h

2. 2 Current ASMF assessment The same ASMF o same AS o same manufacturing site o same route of synthesis often used in different dossiers for multiple procedures assessed by different assessors. o MRP/DCP o CP o Human/veterinary -Currently there is no Worksharing -Currently there is no common platform for information on ASMFs in Europe -No ASMF-AR database

3. 3 Ad-hoc group on ASMF assessment Scope: -Procedural aspects of ASMF assessment Goal: -To investigate the feasibility - practical and legal aspects of, and consider proposals for: o one central assessment for ASMF going through CP and DCP o a centralised database for all AR of ASMFs o an EU numbering system for ASMFs -To start with a pilot project Composition of the group: o CMD-h (&v) o Experts from NCAs o CHMP/CVMP (Chair of the QWP) o EMA o EDQM

4. 4 Ad-hoc group on ASMF assessment Several issue have been discussed & clarified already, & Discussions about a common repository for ASMF-ARs A common ASMF-AR repository may contribute to the reduction of overall workload by »Referring to or »Re-using assessments that already have been made in the EU regulatory network.

5. 5 Requirements for a common platform The platform should be designed in such a way that it allows all concerned parties to participate without problems. The platform should be designed in such a way that it allows data-exchange with other systems. As far as possible agreed EU-IT interoperability measures as e.g. RDM and EUTCT have to be used. The platform has to be implemented in a secure way, ensuring that only authorized persons/agencies have access to the system.

6. 6 AR-submission In addition to the AR-file(s) the relevant meta-data for the ASMF should be entered The system should allow for a connection to CTS for procedural data Searching: The system should allow a Google-like search -documents content or -within the attached meta-data.

7. 7 Hosting the ASMF-AR platform -2 „friendly volunteers“ are prepared to host the database for ASMF-ARs:  BfArM/DIMDI (within CTS)  EDQM (within the existing EDQM DB) HMA to decide which option to be chosen

8. 8 CTSEDQM Fully meets the requirements as stated in the specification document xx Link to regulatory MR/DC proceduresx- Used in daily workx- Support by CTS helpdeskx- Information about EDQM inspections for manufacturers of APIs -x One Data base for ASMF and CEP-x Pros & Cons of CTS vs EDQM

9. 9 costs for development timelinesowner CTS 25.000.- €, 2011 balanced against a surplus from preceding CTS budget Dec. 2011 - for testing HMA EDQM 10.000.- €Nov. 2011 - for testing EDQM (Council of Europe)

10. 10 HMA decision HMA to decide which option to be chosen for further development  BfArM/DIMDI (within CTS)?  EDQM (within the existing EDQM DB)?