Submission of new substance and IMP data in the extended EudraVigilance Medicinal Product Dictionary (XEVMPD)

Transcription

1 EMA Implementation Working Group with EU Pharmaceutical Industry Associations on the implementation of Article 57(2), second subparagraph of Regulation (EC) No. 726/2004 Submission of new substance and IMP data in the extended EudraVigilance Medicinal Product Dictionary (XEVMPD) Data Collection and Management section 5 December 2012 An agency of the European Union

2 Regulatory background As per EudraLex Volume 10, Communication from the Commission Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use ( CT-3 ) (2011/C 172/01): Paragraph 104 as follows: It should be emphasised that the sponsor should provide, before completing the clinical trials application form(54), information on: the IMP in the EudraVigilance Medicinal Product Dictionary ( EVMPD ) (55), (56), the data in free-text fields should be entered in English, only reports complying with the validation rules (57) are accepted in EVCTM, the data in coded fields should contain internationally agreed terminologies, formats and standards for the conduct of pharmacovigilance. 1

3 Regulatory background (55) In order to standardise information between clinical trial applications and related SUSARs reported to the competent authorities, a list of all active substances entered in the EudraVigilance Medicinal Product Dictionary, including development substances codes, will be made available in the public domain for use in completing the clinical trial application form for EudraCT in the relevant fields. (56) A help function will be available by the Agency for sponsors who have difficulty with accessing or entering information in EVMPD. (57) See Note for guidance EudraVigilance Human Processing of safety messages and individual case safety reports (ICSRs), Doc. Ref. EMA/H/20665/04/Final Revision 2 of 15 October

4 Registration with EudraVigilance Sponsors need to register with EudraVigilance to submit information on the substance/ IMP in the EudraVigilance Medicinal Product Dictionary ( EVMPD ), For registration info please consult: for information on how to register as new Sponsors in EudraVigilance and the XEVPRM community for information on how to register for ICSR/SUSAR reporting 3

5 Registration with EudraVigilance Sponsors can request EMA to insert a new substance or investigational medicinal product in the XEVMPD on their behalf EMA will perform data entry on behalf of the Sponsor only once and whilst the Sponsor is completing the full registration with the EudraVigilance system Processes in place: I. Request for a new substance to be entered in the XEVMPD II. Request for a new development / investigational medicinal product 4

6 I. Request for new substance in the XEVMPD New development substance request via EudraCT application 1. Sponsor submits the request via the EudraCT Application Form providing information on Sponsor and the substance to be added in the XEVMPD 2. The above information is received by the EudraVigilance Helpdesk 5

7 I. Request for new substance in the XEVMPD 3. EudraVigilance team, initiate provisional registration of the Sponsor within EudraVigilance System based on the data provided by the Sponsor 4. EudraVigilance Team submits new substance in the XEVMPD using the Sponsor s credentials 5. Sponsor receives following information from EudraVigilance Helpdesk: EV Code of the new inserted substance Details of the Sponsor s provisional registration form with EudraVigilance Instructions how to achieve full registration with EudraVigilance Sponsor is required to complete the registration in EV and check accuracy of the EV registration Form and data provided in the xevmpd 6

8 II. Request for new development / investigational medicinal product 1. Where it is not possible for the Sponsor to promptly register with EudraVigilance System, EMA may insert a new investigational medicinal product in the XEVMPD on their behalf and only once per Sponsor e.g. to assist in case of to time constraint, unavailable documents requested for full registration 2. Sponsor may contact the EudraVigilance Registration Team requesting a provisional registration 3. EudraVigilance Registration Team provide the Sponsor with an Excel form to be populated with the details of their IMP/DMP to be provided in the XEVMPD Supporting documents are also requested (i.e. Investigator s Brochure) 7

9 II. Request for new development / investigational medicinal product Form outlines Sponsor Information IMP Information Substance Information 8

10 II. Request for new development / investigational medicinal product 3. EudraVigilance team, initiate provisional registration of the Sponsor within EudraVigilance System and based on the data provided by the Sponsor 4. EudraVigilance Team submits new IMP in the XEVMPD using the Sponsor s credentials 5. Sponsor received following information from EudraVigilance Helpdesk: EV Code of the new inserted IMP Details of the Sponsor s provisional registration form with EudraVigilance Instructions how to achieve full registration with EudraVigilance Sponsor is required to complete the registration in EV and check accuracy of the EV registration Form and data provided in the 9 xevmpd

11 10 Thank you