Harmonization of Labeling Across. Active Moiety in the EU. Introduction. What does it mean for Core Labeling? Disclaimer 10/7/2011

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1 Harmonization of Labeling Across Products with Same Active Moiety in the EU Introduction What does it mean for Core Labeling? Barbara Lachmann, MD Merck KGaA Bethesda (MD) October 13-14, 2011 Disclaimer The views and opinions expressed in the following PowerPoint slides are those of the individual id presenter and should not be attributed t to Drug Information Association, Inc. ( DIA ), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated. These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. i All rights reserved. Drug Information Association, DIA and DIA logo are registered trademarks or trademarks of Drug Information Association Inc. All other trademarks are the property of their respective owners. Drug Information Association 2 1

2 The EU Challenge 27 countries (plus associated countries Iceland and Norway) with individual regulatory authorities Different regulatory approval procedures: Centralized procedure (CP - via European Medicines Agency) Mutual recognition/decentralized procedure (MRP/DCP) National procedure Drug Information Association 3 Centralized Procedure Results in one single marketing authorization across all 27 countries (plus similar authorizations in Iceland and Norway) Summary of Product Characteristics (SmPC) identical in all 29 countries No need for harmonization efforts Drug Information Association 4 2

3 Mutual Recognition/DC Procedure Common evaluation process in either all countries or a selection of countries (choice of the applicant) Results in national marketing authorizations SmPC for the respective company similar in all participating countries (differences in administrative details only) Drug Information Association 5 National Procedure Individual application resulting in individual marketing authorizations per country applies only to products which have been on the market prior to (mandatory) introduction of the CP, MRP or DCP or to products which are only intended for marketing in one single country SmPC is usually different from one country to the next and may also be different between marketing authorizations of different companies Drug Information Association 6 3

4 'Mixed' situation MRP in some countries plus national procedure in others applies only to products which have been on the market prior to (mandatory) introduction MRP or DCP often resulting from EU Accession of new Member States (10 countries in 2004, 2 countries in 2007) MRP/DCP starting from different countries for different companies on the same active moiety SmPC is usually different between countries involved in the MRP or DCP and those with parallel national authorization procedure and may also be different between marketing authorizations of different companies Drug Information Association 7 Options for harmonization Procedural options exist to ensure a harmonized decision within an MRP or DCP procedure for an individual product, e.g. if one or several Member States disagree with the benefit-risk conclusion proposed by the Reference Member State because of a serious risk to public health For harmonization across products with the same active substance or from different marketing authorization procedures, harmonization for products already authorized may be desirable Drug Information Association 8 4

5 What does it mean for Core Labeling? Drug Information Association 9 Implementation of Core Labeling Harmonization procedures provide an opportunity for implementation of existing Core Labeling on the issues in question, if not achieved previously For new issues brought up by authorities, a thorough evaluation of data by the company is necessary to determine the company position Authorities can always request modifications to the company proposals Drug Information Association

6 Dir 2011/83/EC, Article 30(1) and (2) Article 30(1) can also be triggered by the company Article 30(2) may need check on announcement of products proposed for harmonization by the EU Member States in the forthcoming year CMDh website To be considered: These procedures may need re-evaluation of issues addressed differently in approved SmPCs can be resource intensive but: option to aim for a harmonized implementation of Core Labeling Drug Information Association 11 PSUR Worksharing Procedure Core Safety Profile is based on common denominator between existing SmPCs in the EU, to be provided by the originator company in SmPC format (sections ) If the Core Safety Information is not yet implemented in all EU SmPCs, it may be advisable to propose to authorities how the final CSP should look like to be consistent with the CSI, rather than wait for the authorities requests Member States can request inclusion of further safety information from their existing national SmPCs which is scientifically justified Challenge: Justification is usually not provided Drug Information Association

7 Implementation of Core Safety Profile From the PSUR Worksharing procedure, one CSP will result, applicable for an active substance which must be implemented in all EU countries however, during the national variation procedure for this implementation, different interpretation by local authorities is sometimes experienced, which leads to deviation on previously agreed issues in addition, safety statements not included in the CSP may nevertheless be requested by local authorities to be maintained in a local SmPC, if it had been included previously Drug Information Association 13 Paediatric Worksharing Procedure Usually, the company proposes wording for the SmPC and Package Leaflet Proposal can be aligned with the Core Labeling if paediatric use is covered in the Core Labeling document As several companies may submit proposals on the same active substance, the authorities will pick what they consider best Thus, no guarantee that the final wording will be aligned with existing Core Labeling Drug Information Association

8 Implementation of Pediatric WS outcome From the Pediatric Worksharing procedure, one set of statements on the pediatric population p will result, applicable for an active substance which must be implemented in all EU countries which may affect several sections of the SmPC mainly section 4.2 Posology and section 5.1 Pharmacodynamic properties, but also section 4.1 and/or safety sections, as appropriate If wording on e.g. dosing in the paediatric population was already present, it is sometimes possible to shape the new proposals to fit with existing wording Drug Information Association 15 Dir 2010/84/EU, Article 23(3) In future, companies will be obliged to regularly check the European medicines web-portal for new scientific conclusions current position paper suggests daily check! Seems as if no further request from authorities may be necessary, but that companies must proactively align with such assessment it may be speculated whether this will change once the system is fully operational and will allow automatic requests to be sent to companies Already now, recommendations from the Pharmacovigilance Working Party have to be implemented on request from authorities, sometimes even if the decision has not (yet) been published usually difficult to negotiate wording Drug Information Association

9 Impact on Core Labeling (1) Concerning CSP or assessments from the PhVWP, the level of detail may go beyond Core Safety Information thus, companies may not want to include the same level of detail in the Core Labeling and/or the CSI CSP may include local peculiarities, which authorities have imposed if different from the company position, the company can choose to omit them in the Core Labeling Drug Information Association 17 Impact on Core Labeling (2) Concerning pediatric data, it remains to be seen whether authorities outside the EU would accept mention of pediatric data which have not led to an indication thus, companies may need to thoroughly consider which part of the information should be included in the Core Labeling and/or the CSI Drug Information Association

10 Impact on Core Labeling (3) As for all authority interaction, a thorough evaluation is necessary to determine whether an authority opinion different to existing Core Labeling would change the company position whether any new issues may need to be included in the Core Labeling and/or the Core Safety Information Harmonization in the EU at least reduces the effort of tracking, if 27 countries have (nearly) identical labeling on specific topics or even for the complete safety profile Drug Information Association