Other EU Activities Contributing to Harmonization of Labeling

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1 Other EU Activities Contributing to Harmonization of Labeling Dr Laurent Brassart European Medicines Agency Medical Information Sector DIA Labeling Harmonisation 2011 Workshop October 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 Overview Why harmonizing EU labeling (SmPC)? Ultimate objective: high-quality information Different situations; several procedures Some specific procedures: Article 31 Articles 45 & 46 Upcoming pharmacovigilance activities contributing to harmonization Conclusion 3 Why harmonizing EU labeling (SmPC)? It should be ensured that a given medicine has the same product information across the EU. ( ) In order to ensure the highest level of harmonisation, further efforts should involve healthcare professionals, pharmaceutical industry and regulatory authorities. (Recommendations requiring amendments to the current legal framework) To facilitate regulatory procedures; e.g. PSUR Drug Information Association 4 2

3 Harmonization toward high-quality SmPC The EC guideline on SmPC applies to all EU medicines Consider all available scientific data Translate the assessment of the scientific data into clinically relevant information for daily practice (according to the SmPC guideline) Detailed information on the assessment (including the reasoning for the scientific judgement) may be published as part of the public assessment report. That will support transparency and will explain the decision making process much better than compiling various data from different sources in the SmPC. 5 Different situations; several procedures Referral procedures Past MSs divergent decisions (Article 30 Dir. 2001/83/EC); Full harmonization of SmPC, labelling and package leaflet. Disagreement between Member States regarding a medicine being evaluated during a mutual recognition or decentralised procedure (Article 29(4) Dir. 2001/83/EC) & Article 5(11) Article 6(12) 6(13) from Regulation (EC) 1084/2003) MAH s claim for new indication (or pharmaceutical form or route of administration) for use in the paediatric population (Article 29 (paediatric) of Regulation (EC) 1901/2006: Based on safety issue (see new pharmacovigilance legislation) Based on Community Interest (Article 31 referrals - Dir. 2001/83/EC) Other procedures contributing to harmonization Pharmacovigilance: PhVWP recommendations and PSUR work sharing Articles 45 and 46 of the Paediatric Regulation Reg. (EC) 1901/

4 Article 31 of Dir. 2001/83/EC in specific cases where the interest of the Community is involved. Broad meaning but particularly to public health interest in the Community (quality, efficacy, safety or pharmacovigilance). May be triggered by the EC, a MS, a MAH or an Applicant. 1 product, 1 active substance, or, a group (class) of products full assessment of the benefit-risk balance of modafinil-containing medicines, review of the risk of nephrogenic systemic fibrosis (NSF) in patients receiving gadolinium-containing contrast agents. Specific aspect or full harmonization of SmPC (particular product) In case of pharmacovigilance trigger, see new pharmacovigilance legislation. 7 Articles 45 & 46 - Reg. (EC) 1901/2006 Obligation for the MAH to submit to the Competent Authority any MAHsponsored studies involving the use in the paediatric population. Art. 45 for studies completed before the date of entry into force of the paediatric regulation. Art. 46 for studies completed after. May result in subsequent update of SmPC (and PL) CMDh recommendation: The MAH should note that the paediatric work-sharing procedure is not a basic harmonisation process. Where there are differences in the product information registered in different Member States, it is the responsibility of the MAH to consider how to address this situation, ti taking into account that it is an objective of the Paediatric Regulation to give children the same access to authorised medicinal products suitable for their use across the European Community. The MAH may consider a range of regulatory options including submission of a series of variations or initiation of a referral procedure in order to achieve a harmonised position

5 New Pharmacovigilance legislation: Procedures contributing to harmonization Article 107c (4) of Directive 2010/84/EU Where medicinal products that are subject to different marketing authorisations contain the same active substance or the same combination of active substances, the frequency and dates of submission of the periodic safety update reports resulting from the application of paragraphs 1 and 2 may be amended and harmonised to enable a single assessment to be made in the context of a periodic safety update report work-sharing procedure and to set a Union reference date from which the submission dates are calculated. Referrals (e.g. Article 107i of Dir. 2010/84/EC) All pharmacovigilance referrals will be discussed by the new Pharmacovigilance Risk Assessment Committee (PRAC) and the Committee for Medicinal Products for Human Use (CHMP) or the Coordination Group for Mutual Recognition and Decentralised Procedures Human (CMDh). Opinions will be adopted as a result. 9 New Pharmacovigilance legislation: Tools facilitating harmonization Article 23 (3) of Directive 2010/84/EU The marketing authorisation holder shall ensure that the product information is kept up to date with the current scientific knowledge, including the conclusions of the assessment and recommendations made public by means of the European medicines web-portal established in accordance with Article 26 of Regulation (EC) No 726/2004 Format in which pharmaceutical companies need to submit information on all of the medicines authorised or registered in the European Union (EU).This information will help the Agency to: create a list of all medicines authorised and registered in the EU, including medicines authorised centrally via the Agency and medicines authorised by regulatory authorities in EU Member States; identify medicines accurately, especially medicines included in reports of suspected adverse reactions; co-ordinate the regulation and safety-monitoring of medicines across the EU

6 Conclusion The SmPC is an integral part of a marketing authorisation which sets out the agreed position as distilled during the course of the assessment processes; new marketing authorisation claim, Pharmacovigilance activities, Referrals, including for harmonisation purpose. The ultimate objective of harmonization processes should be the provision in the SmPC of patient-oriented, evidence-based, reliable and up to date information on how to use safely and effectively the authorised medicine. The new pharmacovigilance legislation will bring new procedures and tools to facilitate better and more harmonized safety information