Grouping and Annual Reporting. Agenda. Grouping of extension and other variations

Transcription

1 Grouping and Annual Reporting Zahra Hanaizi Scientific Administrator Safety & Efficacy of Medicines 1 Agenda Grouping of type IA & Periodic Report Rules and examples Procedural aspects Grouping of extension and other variations Cases of grouping defined in Annex III Other cases of grouping: EMEA approach Procedural aspects 2 1

2 Grouping of type IA & Periodic Report 3 Grouping of type IA variations (1) Article 7.2(a) where the same minor variations of type IA to the terms of one or several marketing authorisations owned by the same holder are notified at the same time to the same relevant authority, a single notification as referred to in Articles 8 and 14 may cover all such variations 4 2

3 Grouping of type IA variations (2) More oethan one etype IA or IA IN affecting one medicinal product MAH 1 IA (1) Prod. 1 IA (2) 5 Grouping of type IA variations (3) One type IA or IA IN affecting more than one medicinal product from the same MAH MAH 1 Prod. 1 IA (1) Prod. 2 IA (1) 6 3

4 Grouping of type IA variations (4) More than one type IA and/or IA IN affecting more than one medicinal product from the same MAH MAH 1 Prod. 1 IA (1) IA (2) Prod. 2 IA (1) IA (2) 7 EMEA recommendations for Periodic Report Periodic report Can be all groups as described Can include type IA IN if notified immediately Submission Within max. 12 months of implementation If Product Information affected and not type IA IN, recommend to submit with next regulatory procedure affecting the annexes 8 4

5 How to submit a group of type IA? Group of type IA for one product 1 application submission (1 ectd sequence) 1 cover letter 1 application form Revised product information (if applicable) Integrated package/supportive documentation covering all changes Procedure numbering : use of suffix /G EMEA/H/C/prod_nb/IA/nn/G 9 How to submit a group of type IA? Group of type IA for several products 1 application submission 1 ectd sequence per product Common cover letter Common application form Individual revised product information (if applicable) Individual supportive documentation covering all changes 10 5

6 How to submit a group of type IA? Group of type IA for several products Procedure numbering One high level procedure number EMEA/H/C/xxxx/IG/mm + Individual sequential procedure number for each product EMEA/H/C/prod_nb/IGmm/nn Example pe EMEA/H/C/xxxx/IG/03 i.e. 3rd IG procedure received affecting >1 MA EMEA/H/C/prod_nb/IG03/52 + EMEA/H/C/prod_nb/IG03/21 11 How will groups of type IA be handled? EMEA Acknowledgement of receipt and review outcome of a notification By Day 30 1 review outcome Listing favourable/unfavourable outcome for each change (for each product) If unfavourable outcome, MAH should cease to apply concerned change immediately at receipt of fax 12 6

7 Grouping of extension and/or other variations 13 Grouping of extension, type II / IB / IA variations Article 7.2(b) where several variations to the terms of the same marketing authorisation are submitted at the same time, a single submission may cover all such variations provided that the variations concerned fall within one of the cases listed in Annex III or, if they do not fall within one of those cases, provided that the competent authority of the reference Member State in consultation with the other Member States concerned or, in the case of a centralised marketing authorisation, the Agency agrees to subject those variations to the same procedure. 14 7

8 Grouping of extensions, type II / IB / IA variations MAH 1 Prod. 1 IB (1) IB (2) MAH 1 Prod. 1 II IB IA MAH 1 Ext Prod. 1 II IB IA 15 Cases for grouping defined in Annex III 16 8

9 Cases for grouping defined in Annex III 14 cases for grouping listed Extension + type II, IB, IA Changes to ASMF, VAMF or PMF Changes to manufacturing process Changes to the Pharmacovigilance system Changes further to PSUR, SO, FUM 17 Annex III examples (1) 1. One of the variations in the group is an extension of the marketing authorisation EMEA approach Extension application + Other clinical or non-clinical changes expected to be linked to the extension + Quality changes affecting the drug substance and/or drug product Examples Extension for a new pharmaceutical form for paediatric use + Type II for new paediatric indication in existing presentations Extension for a new strength + Type II for change in the manufacturing process 18 9

10 Annex III examples (2) 2. One of the variations in the group is a major variation of type II; all other variations in the group are variations which are consequential to this major variation of type II EMEA approach Corresponds to current interpretation of consequential changes Examples Type II for new indication + Type IB or IA for addition of new pack size required for use in new indication Type II for substantial change to the manufacturing process of the active substance + Type IB for change more than 10 fold increase to the approved batch size + Type IA for addition of new specifications parameters to the specification with the correspond test method 19 Annex III examples (3) 11. All variations in the group are consequential to the assessment of a given periodic safety update report EMEA approach Corresponds to current practice Examples 3 rd PSUR assessment report request to update: section 4.4 and 4.8 with adverse reaction A + section 4.8 with adverse reaction B + section 4.4 with warning related to adverse reaction C Only 1 variation (section III.1 number 3) 20 10

11 Other cases of grouping according to Article 7.2(b) EMEA approach 21 General principles and conditions Grouping of variations should always be justified Changes should be consequential and/or related i.e. meaningful to be reviewed simultaneously Quality, Nonclinical and Clinical cannot be mixed unless justified Quality variations to active substance cannot be mixed with finished product variations, unless consequential/justified Grouping should not delay the submission and implementation of updates to the safety information 22 11

12 Examples of acceptable grouping - Quality Quality example 1TypeIB- extension of a re-test period of the active substance 1 Type IB - change in the storage conditions of the active substance Quality + administrative example 1 Type IB extension of shelf life of finished product as packaged for sale 1 Type IA IN change in name and/or address of manufacturer responsible for batch release 1 Type IA change in ATC code 23 Examples of acceptable grouping - Clinical Generic/hybrid/biosimilar Grouping of type IB or II for each change applied to the reference product Grouping of several drug-drug interaction studies 1 Type II variation with DDI study with rifampicin 1 Type II variation with DDI study with oral contraceptive Change of indication + legal status 1 Type II to change the indication 1 Type II to switch to OTC 24 12

13 Additional cases of acceptable grouping Type IB section III.1 number 3(a) Implementation of agreed wording change(s) requested by the CHMP for which no new additional data are submitted by the MAH Can be grouped with a subsequent planned variation Not possible to group with quality variation Grouping should not delay too much the submission and implementation of requested changes 25 Examples of non-acceptable grouping 2 different indications Renal cell carcinoma + non-small cell lung cancer Not consequential or meaningful 1 Type II with interaction study results 1 Type II with PK study results in renal impairment Broad CCDS update 1 Type II to update posology information in section Type II to update section 4.9 with overdose case 1 Type II to update section 5.1 with new pharmacodynamic property data 1 Type II to update section 5.3 with embryotoxicity study 26 13

14 Procedural aspects 27 How to submit a group of extension and/or variations? 1 application submission as 1 ectd sequence including: 1 cover letter 1 variation application form (+ 1 extension application form, if applicable) Revised product information (if applicable) Integrated package/supportive documentation covering all changes 28 14

15 How will groups be handled? (1) Procedure numbering Highest procedure type Use of suffix /G EMEA/H/C/prod_nb/X/nn/G Timetable according to the highest procedure type included in the group e.g. X + II + IB X timetable 1 assessment of all changes 29 How will groups be handled? (2) NOT a all or nothing approach BUT partial acceptance 1 Opinion/Notification listing variations which are approvable and not approvable (unless withdrawn) If withdrawn: Opinion/Notification reflects final outcome i.e. highest approvable variation in group X + II + IB X withdrawn II opinion & decision making procedure 30 15

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