1
play

1 Key Item 1: Harmonisation Initial Marketing Authorisation - PDF document

Feb 12, 2024 •311 likes •382 views

Introduction The new variation system Commission Regulations (EC) 1084 & 1085/2003 Considerable burden for industry and authorities Impact on NCAs Review project launched in 2006 by EC EC-Objectives: - clearer, simpler,

  1. Introduction The new variation system – • Commission Regulations (EC) 1084 & 1085/2003 • Considerable burden for industry and authorities Impact on NCAs • Review project launched in 2006 by EC EC-Objectives: - clearer, simpler, more flexible - reduce administrative burden Susanne Winterscheid - adapt to ICH concepts Federal Institute for Drugs and Medical Devices, BfArM 53175 Bonn, Germany - further harmonisation without compromising human and animal health necessary legal strands … Aim of the Review Review of • single regulatory text, covering changes to the legal basis of all marketing authorisations 1 the Variations Reg. Co-decision procedure (2001/83/EC, 2001/82/EC, 726/2004) - human / veterinary = common set of rules for variations, regardless of autorisation route of the - centralised product - decentralised / Review of Comitology the content of 2 Regulatory procedure the Variations Reg. with scrutiny (1084&1085/2003) Source: EU-Commission Key Items of the Review Radical and concrete approach to simplification The New Variation Regulation 1. Harmonisation to national authorisations (Codecision proposal) 2. Design space (ICH Q8 – Q10) 3. ‘Do and Tell’ and ‘Annual Report‘ 4. Worksharing (incl. Grouping) 5. Type IB by default 1

  2. Key Item 1: Harmonisation Initial Marketing Authorisation Current situation with national variations 84% 2001/83/EC 15% � Independent System 2001/82/EC 726/2004 1% � eg. AT (§ 24 AMG), DE (§ 29 AMG) Mutual ‘Purely National’ Centr. recognition � Mixed System Post- � categorisation of changes according to authorisation changes CR 1084/2003 - but different time lines Variations National variation Regulations rules � Full Implementation of CR 1084/2003 1084/2003 1085/2003 Source: EU-Commission Current variation system in DE Co-decision part – current status The current variation system in Germany is a 1. Public Consultation (Start: 10 July 2007) smooth, unbureaucratic and effective system 2. Outcome of the Public Consultation (03 � based on the legal self-responsibility of October 2007): 19 written responses the MAH 3. Adoption of the Commission proposal on � based on a defined list of major variations variations (04 March 2008) whole rest are simple notifications � implicit approval of approval procedures after 4. Adoption by the European Parliament (22 October 2008) 3 months � Germany has high interest in achieving a 5. Council discussion during the Slovenien and French Presidency European system as simple as the national one Where to find published informations? ��������������������������������������������������������������� ������� �������������������������������������������������������� ������� ������� �������������������������������������������������������� �������������������������������������������������������� The New Variation Regulation (Comitology proposal) 2

  3. Comitology part – current status Scope of the new Variation Regulation 1. Public Consultation (Start: 25 October 2007) As currently 2. Outcome of the Public Consultation (14 • ex-concertation/MRP/DCP January 2008): 48 written responses + discussion with Pharm Committee, HMA, • following harmonisation (Article 30 and 31(1)) NtA, CMD and Industry for authorised medicinal products 3. First discussion of an incomplete draft of the Outside: EC (03 April 2008) in the Standing Committees (SC‘s) • change of the MAH 4. Further SC‘s discussion on 02 June 2008 • changes to registered homeopathic and 5. Final discussion and voting on 10 June 2008 traditional herbal medicinal product (despite they are elegible for the MRP/DCP) 6. Scrutiny process until 13 September 2008 Key Item 2: Design space Key Item 3: „Do and Tell“ (Type IA) Design space • (can be) implemented by the MAH before • implementation of ICH Q8-Q10 notification to CA • changes within the approved design space • reporting to CA either are no notifications or variations – immediately (for defined Type IA eg change Introduction of address, … ) • as part of an initial marketing authorisation – within 12 months at the latest (no fixed date, ‚Annual Report‘) • as a Type II Variation – ‚Annual Report‘ alone or together with an � new design space immediate reporting � change to an approved design space Key Item 4: Grouping Key Item 4: Two Key Definitions … 2-dimensional matrix • Grouping – several changes to one MA what to place in one application – identical change to several MA‘s – (several identical changes to several MA) Worksharing at the same time for the same MAH how to evaluate an application • classification according to the highest level of the individual submission type optional for the MAH � all or nothing approach? • therefore worksharing on a grouped No, as you submit an application, but CA grant a variation application is possible 3

  4. Key Item 5: Worksharing - (2) Key Item 4: Worksharing - (1) • Procedure • for „… several MA‘s owned by the same holder.“ – submission of application to all CA concerned • for Type IB, Type II and grouped variations – validation by ‚reference authority‘ • Coordination – timeframe of a Type II-variation – Agency - if one central MA is included • possibility of a clock stop • scientific opinion within 60 days (standard – CMD (h/v) - in all other cases procedure) • Evaluation (‚reference authority‘) • reduction (safety, 30 days) or extension (indications, 90 days) – Agency: Scientific Committees eg. CHMP – relevant authorities (concerned by the application) – CMD: CA of a MS concerned, chosen by shall recognise the opinion of the ‚reference CMD considering recommendation by MAH authority‘ within 30 days or raise PSRPH (resulting in a CMD or CHMP referral) „Type IB by default“ - (2) Key Item 5: „Type IB by default“ - (1) … cont. alternative: • defined lists in classification Guideline for • MAH can ask CMD (national MA) or Agency Type IA, II and line extensions (regularly amended (central MA) for a scientific recommendation on the classification of unlisted changes by IB variations after Art. 5 procedure) • unlisted changes are by definition Type IB • scientific recommendation within 45 days from CMD or Agency but, • CMD and Agency shall cooperate and publish if during the validation the CA consider a the scientific recommendations following significant impact on quality, safety or deletion of commercial confidential efficacy, the application is considered a informations (and this will effectively lead to Type II variation an update of the Guidelines) Other items - (2) Other items - (1) • Implementation • National implementation of SPC, PL and labelling – the current Variation Regulations shall after a Type II-Variation? – implicit approval within 30 days after submission of continue to apply for valid notifications or (high quality) translations pending variations • How long should/could be the current stock on the – shall enter into force on the 20th day market? following publication – national issue • Referrals – shall apply from <1 year after entry into – for Type II and Worksharing (but Article 35(2) of force>, with the exception of Article 5 Directive 2001/83/EC, as amended is applicable) ( Recommendation on unforeseen variations ) – only by NCA (not MAH!) 4

  5. Next Steps … - (1) Adoption Co-decision Codecision 1 • Co-decision: EC proposal – ongoing discussion in the Council 2008 2009 2010 2011 – 1 st reading finished in Parliament EC adoption Transitional Application of 2 • Comitology: (MRP/CP period the new rules only) (MRP/CP only) – scrutiny procedure at EP until 13 th Fully September 2008 harmonised Comitology system – formal adoption by EC and publication applies Inclusion of Transitional • Further work on other items: 3 purely national period – Key Item 1 variations (3rd step comitology – Fees (Council Regulation for the CP) proposal) Source: EU-Commission; modified Next Steps … - (3) Next Steps … - (2) Guidelines cont. Guidelines • Procedural Guideline Proposal • The WGs on the Procedural and the – CMD (h+v) subgroup Classification Guideline Proposal are – EMEA coordinated by the ‘Variation Task Force‘: – CxMP • Classification Guideline Proposal –EMEA – CMD (h + v) –CHMP – EMEA –CVMP – QWP –CMD (h)/(v) – BWP – IWP Next Steps … - (4) Conclusion � Commission proposal is a big step into right direction cont. Guidelines � Many aspects of the simple German system have been considered � New variation system is expected to disburden the NCAs • The guidelines will be forwarded by the from huge workload with variation procedures ‘Variation Task Force‘ to the European � NCAs will be involved in further development through Commission and thereafter for external Variation Subgroup and other Committees and working groups consultation � Classification and Procedural Guidelines should be finalized asap and well before implementation of the new system … 5

Recommend

More recommend