Report on status of on-going Article 45 & 46 work-sharing procedure. Shirley NORTON MHRA (UK) Alban DHANANI AFSSAPS (FR)

Transcription

1 Report on status of on-going Article 45 & 46 work-sharing procedure Shirley NORTON MHRA (UK) Alban DHANANI AFSSAPS (FR)

2 Why a worksharing? Making information available for healthcare professionals by publication of PARs and inclusion of information in the SPC, Harmonised information in EU on use of medicines in children, No duplication of national assessments. No legal framework in the EU legislation before the publication of the Paediatric Regulation Articles 45 & 46

3 Article 45 - Paediatric Regulation By 26 January 2008, any paediatric studies already completed by the date of entry into force, in respect of products authorised in the Community shall be submitted by the MAH for assessment to the competent authority. The competent authority may update the SPC and Package Leaflet, and may vary the marketing authorisation accordingly. Competent authorities shall exchange information regarding the studies submitted and their implications for marketing authorisations concerned. The EMEA shall coordinate the exchange of information.

4 Article 46 - Paediatric Regulation Any other MAH-sponsored studies which involve the use in the paediatric population of a medicinal product covered by a marketing authorisation, whether or not they are conducted in compliance with an agreed PIP, shall be submitted to the competent authority within 6 months of completion of the studies concerned. ( ) The competent authority may update the SPC and PL, and may vary the marketing authorisation accordingly. Competent authorities shall exchange information regarding the studies submitted and, as appropriate, their implications for any marketing authorisations concerned. The EMEA shall coordinate the exchange of information.

5 Scope of Article 45 Any paediatric studies already completed by 26 January 2007 Deadline for submission of information: For line-listing & Annex I: 26 January 2008 For Annex II: 26 April 2008

6 Scope of Article 46 All MAH-sponsored paediatric studies completed after 26 January 2007 Deadline for submission of information: For the cover letter & line-listing: within 6 months of completion of the paediatric studies

7 Organisation of the Worksharing Submission of the line-listings Prioritisation phase Appointment of Rapporteurs Submission of paediatric studies to the Rapporteur in electronic format only within one month of the request The coordination of the worksharing process will be done by the Paediatric Subgroup CMD(h)/EMEA

8 Requirements for submission of information Each MAH has to fill in the line-listing with the annexes (art.45) or the cover letter (art. 46) for all their approved medicinal products subdivided for each MS. This obligation applies to all authorised medicinal products: Nationally authorised products including MRP/DCP Centrally authorised products Line-listings/cover letter have to be sent to each Competent Authority and EMEA in electronic format only where the medicinal product is authorised.

9 Submission of paediatric studies New paediatric studies (art. 46) and paediatric studies not yet submitted to NCAs (art. 45) and will have to be forwarded to the Rapporteur, once appointed: within one month of request, in electronic format only. MAHs will be informed by the EMEA about the appointment of the Rapporteur, and by the Rapporteur about the timetable. A dedicated Paediatric mailbox is used by the Member States for circulation of information (timetable, assessment reports, comments )

10 Assessment of Paediatric data Timetable based on a 90 day Type II variation procedure (with the possibility of a clock-stop) Conclusion of the assessment with a proposal for inclusion of information in the SPC and PL, if appropriate Publication of the Public Assessment Report (PAR) within 60 days after the end of the procedure Submission of a Type II Variation by the MAH to update the product information within 90 days after the publication of the PAR

11 Assessment of Paediatric data For Art. 45: Successive waves of assessment New wave every 3 months (subject to review) active substances per wave In case of disagreement between the Member States for Art. 45 & 46, the matter will be referred to the CMD(h) by the Rapporteur

12 Flow-Chart D0 D70 D85 D89 D90 D105 D115 D120 Start of the procedure Preliminary paediatric assessment report (PPdAR) Comments from Member States Clock-Stop if needed / RSI as appropriate Final paediatric assessment report (FPdAR) Break-out meeting if needed Comments from Member States End of procedure. Final agreed position used as supporting documentation in Type II Variation as required

13 Article 45 / First wave of evaluation List of active substances Started in October 2008 Amikacin Bisacodyl Calcitonin (salmon) Diclofenac Fentanyl Leuprorelin Mesalazine Quetiapine Simvastatin* Amlodipine Budesonide Ciprofloxacin Felodipine Lamotrigine Lisinopril Oxazepam Rifaximin Tranexamic acid * Already started

14 Official List for Art. 46 List of active substances Rapporteurs appointed in CMD(h)/EMEA subgroup Active substances being considered in sub-group Appointment of rapporteurs to be made on a regular basis List will be published when agreement reached to start procedure

15 Guidelines - Q&As Information published on CMD(h) website: PROCEDURAL GUIDANCE CONCERNING SUBMISSION OF INFORMATION ABOUT MEDICINAL PRODUCTS AS REQUESTED BY THE PAEDIATRIC REGULATION BEST PRACTICE GUIDE ARTICLE 45 PAEDIATRIC REGULATION - EU WORK SHARING PROCEDURE PROCEDURAL ADVICE CONCERNING SUBMISSION OF INFORMATION ON PAEDIATRIC DATA ACCORDING TO ARTICLE 46 OF THE PAEDIATRIC REGULATION Q&AS ON THE PAEDIATRIC REGULATION

16 Conclusion Paediatric work sharing is now underway procedures build on success of previous informal arrangements Task is large important for both MAHs and NCAs to respect timelines Guidance is available please follow instructions MAHs may liaise with potential RMS if priority for a substance is requested All are working to achieve improvements for medicines for children in EU