Active Substance Master File (ASMF) worksharing procedure

Transcription

1 Active Substance Master File () worksharing Working Group Nienke Rodenhuis September Table of Contents Why needed History How does it work Status Support 2 2

2 Why do we need a worksharing for s? When the same is used in multiple s and/or Member States, it can lead to Duplicated Divergent decisions Frequent updates (at NCA request) Reduced oversight of the Increased workload (all parties) 3 3 What has been done to solve the problem? Assessment Worksharing Procedure A simple way for Competent Authorities to share report for the same version of the Letter of Access 1 Submission Details Form 2 report repository EU/ repository number 1 Annex 2 and 2 Annex 3 of CHMP/QWP/227/02 Rev 3/Corr Guideline on the 4 4

3 History Goal: There should be 1 for Used in national, MRP/DCP and CP, variations For human & veterinary products April 2010 : discussion in HMA June 2010 : first meeting of -WG April 2011 : meeting with interested parties and HMA decision December 2013 : start of pilot-phase January 2017 : end of pilot-phase, worksharing is business as usual 5 5 Collaboration Members: All EU national competent authorities Observers : EDQM, IGDRP Continuous interaction with stakeholders At QWP plenary meetings (intra-network) At bimonthly WG meetings (intra-network) holders taking part in WS and Interested Parties (AESGP, EFPIA, EGA, EUCOPE, APIC/CEFIC, IFAH, EGGVP) 6 6

4 How does the worksharing work? EU/ repository number + Submission Details Form Tracks where the same version of the is used in different s & Member States report repository allows Competent Authorities to share easily the report ( holder acknowledges sharing of reports in the Letter of Access) 7 7 How does the worksharing work? Designed to operate within existing legislation, regulatory s and timetables NO IMPACT ON PROCEDURE TIMINGS Reduces CA requests for updates Harmonises Improves oversight of the Reduces workload & MA holders (plus Competent Authorities) 8 8

5 The worksharing Includes New s submitted in DCP, CAP or national marketing authorisation applications and variation applications Undergoing / previously assessed in a DCP/MRP/CAP NB: s undergoing or have been assessed in national only s may still be accepted in the worksharing, but may result in a new evaluation of the. holders should list these applications in the Submission Details Form so that the report may be requested and used in the evaluation. NB: If the same data have been submitted in a CEP application, holders should notify Competent Authorities so that the report may be requested from the EDQM Updates to a worksharing can be submitted in a MA or MAV application using any regulatory in order to preserve its lifecycle Use of the is strongly recommended, but not mandatory 9 9 The worksharing Assessments of new s composed of 2 to 3 stages -AR repository uses timetables to identify parent Other s are Daughter s Parent is responsible for drafting report QA review of the report by Parent CMS/Daughter RMS Review of report by Parent CMS Only Major Objections raised during reviews Procedure repeats as above until is complete 10 10

6 Current number of s in Worksharing Status August 2017: Number of -numbers issued : 128 Accepted for use ( finalised) : 40 Under evaluation : 58 Reserved : 26 s withdrawn : What support is available? Relevant to worksharing and worksharing s Applicable to all s Assessment worksharing guidance Guidance on CMD Q&As on worksharing Training on the worksharing CMD Q&As on Additional guidance on documents Completing & submitting annex 2, 3 &

7 Links to support documents Guideline on the (CHMP/QWP/227/02/Rev3/Corr) Additional guidance on documents relating to an active substance master file CMD Q&As on the + Q3.4 of the CMD Q&A on Variations (concerning updates) The worksharing Training material on the worksharing CMD Q&As on the worksharing What support is available? For issues concerning the work sharing, please contact the CMD Working Group on s H-CMDhSecretariat@ema.europa.eu The subject header of the should clearly state worksharing 14 14