Review of Legislation 2001

1. Review of Legislation 2001

2. The Review Completed on 1 Apr 04 Effective from 20 Nov 05 20 years+ life span Focus Improvement of procedures �New� products EU enlargement Globalisation Required by Regulation 2309/93/EEC

3. EFPIA Key Topics Data protection Registration procedures � 25MS Competitiveness and flexibility Single trademark Co-marketing/Co-promotion PV Added therapeutic value Information to patients

4. Good morning and welcome to Bristol-Myers Squibb UK Good morning Good morning and welcome to Bristol-Myers Squibb UK Good morning

5. Composition of theNew EU Pharmaceutical Legislation Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use





10. Good morning and welcome to Bristol-Myers Squibb UK Good morning Good morning and welcome to Bristol-Myers Squibb UK Good morning


12. SAWP and SAG Scientific Advice Working Party (SAWP) Provide scientific advice and protocol assistance to sponsors, companies, research institutes Scientific Advisory Group (SAG), formerly TAG Provide independent recommendation on scientific and technical matters relating to products under evaluation OR any other scientific issue Oncology HIV/Viral disease Diagnostics CNS/Psychiatry Anti-infectives Cardiology Endocrinology/Diabetes




16. Commission prepares draft decision within 15 days MS Applicant Standing Committee (SC) Opinion in writing 22 days max (5 days min) MS can request plenary session Commission can refer Applicant back to EMEA based on new questions raised by MS Commission adopts SC Decision 15 days Centralised Procedure












29. IMPLEMENTATION OF THENEW PHARMACEUTICAL LEGISLATION

30. European Medicines Agency European Commission Heads of Agencies

31. European Medicines Agency (EMEA) CHMP/EMEA Implementation Task Force (CEITAF) � first meeting 14 Feb 05 Human medicines Telematic projects Parallel distribution EMEA Innovation Task Force (ITF) Meets Mon of CHMP week Membership unknown Meets Mon of CHMP week Membership unknown

32. Human Medicines Product Information CHMP opinion in collaboration with WHO Compassionate use Info to patients and the public � �EuroPharm� database of all EU approved medicines Small and medium-sized companies - admin and scientific support Conditional approvals Cooperation with the WHO in giving opinions for the use of medicines outside the EU (EMEA/CHMP/5579/04) 23 May 2005 Operation Date Article 58 of Regulation (EC) No 726/20041 (�the Regulation�) establishes a mechanism whereby the European Medicines Agency (EMEA) may give a scientific opinion, in the context of cooperation with the World Health Organisation (WHO), for the evaluation of certain medicinal products for human use intended exclusively for markets outside the Community. For this purpose, an application shall be submitted to the Agency in accordance with the provisions of Article 6. The Committee for Medicinal Products for Human Use may, after consulting the World Health Organisation, draw up a scientific opinion in accordance with Articles 6 to 9. The provisions of Article 10 shall not apply. Article 58 of the Regulation responds to the need to protect public health and to give scientific assistance to non-member countries in the context of cooperation with WHO whilst at the same time allowing rapid access to those countries for important new medicinal products. Whether a product falls within the scope Article 58 of Regulation (EC) No 726/2004 shall be decided upon on a case-by-case basis in cooperation with WHO. Medicinal products falling within the scope of the current Article 16 of the draft Regulation on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems (2004/0258 (COD)) will be eligible to the �Article 58 procedure� when these provisions enter into force. In addition to new medicinal products, also existing active substances with a different indication, new combinations of existing active substances, and formulations of interest for markets outside the Community may be considered. The operation of this procedure is without prejudice to another entity�s intellectual property rights. The application for this procedure does not exclude a future application for a marketing authorisation in the Community. In this Guideline, �a CHMP scientific opinion� should be understood as a CHMP scientific opinion for the evaluation of medicinal products intended exclusively for markets outside the community in the context of cooperation with WHO. The CHMP scientific opinion assessment report shall contain the conclusions on the Quality, the Safety and Efficacy of the medicinal product and will take into account appropriate benefit/risk scenarios on the populations and conditions of use as documented with clinical data by the applicant. Cooperation with the WHO in giving opinions for the use of medicines outside the EU (EMEA/CHMP/5579/04) 23 May 2005 Operation Date Article 58 of Regulation (EC) No 726/20041 (�the Regulation�) establishes a mechanism whereby the European Medicines Agency (EMEA) may give a scientific opinion, in the context of cooperation with the World Health Organisation (WHO), for the evaluation of certain medicinal products for human use intended exclusively for markets outside the Community. For this purpose, an application shall be submitted to the Agency in accordance with the provisions of Article 6. The Committee for Medicinal Products for Human Use may, after consulting the World Health Organisation, draw up a scientific opinion in accordance with Articles 6 to 9. The provisions of Article 10 shall not apply. Article 58 of the Regulation responds to the need to protect public health and to give scientific assistance to non-member countries in the context of cooperation with WHO whilst at the same time allowing rapid access to those countries for important new medicinal products. Whether a product falls within the scope Article 58 of Regulation (EC) No 726/2004 shall be decided upon on a case-by-case basis in cooperation with WHO. Medicinal products falling within the scope of the current Article 16 of the draft Regulation on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems (2004/0258 (COD)) will be eligible to the �Article 58 procedure� when these provisions enter into force. In addition to new medicinal products, also existing active substances with a different indication, new combinations of existing active substances, and formulations of interest for markets outside the Community may be considered. The operation of this procedure is without prejudice to another entity�s intellectual property rights. The application for this procedure does not exclude a future application for a marketing authorisation in the Community. In this Guideline, �a CHMP scientific opinion� should be understood as a CHMP scientific opinion for the evaluation of medicinal products intended exclusively for markets outside the community in the context of cooperation with WHO. The CHMP scientific opinion assessment report shall contain the conclusions on the Quality, the Safety and Efficacy of the medicinal product and will take into account appropriate benefit/risk scenarios on the populations and conditions of use as documented with clinical data by the applicant.

33. Human Medicines Fast track reviews Increased scope of CP Reinforced role in the provision of SA to companies Exceptional circumstances Data protection (8 yr)/Market protection (10 yr) +1yr Risk management evaluation/procedure If during the first 8 years of the 10 years, the MAH gets one or more new indications (i.e. those that have significantly clinical benefits vs current therapies) � extra year protectionIf during the first 8 years of the 10 years, the MAH gets one or more new indications (i.e. those that have significantly clinical benefits vs current therapies) � extra year protection

34. Human Medicines PSUR cycle Compliance inspection and monitoring PV � post authorisation studies; communications Transparency and commercial sensitive info Publication of withdrawn and refusal opinions Re-exam of opinions ��..etc PSUR At least every 6M during the first 2 years following initial placing on the market and then, once a year for the following 2 years. After that, every 3 years (unless otherwise agreed during granting of MAH). Must be provided immediately upon request PSUR At least every 6M during the first 2 years following initial placing on the market and then, once a year for the following 2 years. After that, every 3 years (unless otherwise agreed during granting of MAH). Must be provided immediately upon request

35. Telematic Projects To meet strategic objectives of EC, EMEA and MA To implement the new legislation EudraVigilance Launched Dec 2001, web-based, safety report info (ICH), extend to allow sponsors to report SUSARS in CT EudraCT Launched May 2004, content, start and termination dates of CT in EU EuroPharm Design phase, MA, cGMP EudraGMP Operational for several years Network of the community MA system Exchange of info between EMEA and Agencies

36. Parallel Distribution Effective May 2004 (Art 57o Reg 726/2004) -Notifications of Parallel Distribution of CP products mandatory, compliant with EMEA notification procedure

37. EMEA Innovation Task Force (ITF) To ensure EMEA-wide coordination of scientific and regulatory expertise in emerging therapies and technologies To provide a forum for early dialogue with applicants Membership? Area of interest Gene therapy, human cell therapy, xenogentic cell therapy, Pharmacogenetics and pharmacoeconomics, new manufacturing technolgies, etc

38. EMEA Innovation Task Force (ITF) Support from EMEA Briefing meetings offered e.g. orphan drug designation, scientific advice or submission of a MAA EC activities Prepare for legislations for advanced therapies e.g. gene therapy, cell therapy and tissue engineering, followed by public consultation

39. European Commission (EC) Draft regulation on the conditional MA (9 Nov 04) - Art 14(7) Reg 726/2004 scope, procedures and criteria for granting conditional MA through CP Public consultations on provisions for small and medium size enterprises (SMEs) 10 Jan 05 - Art 70(2) Reg 726/2004 Based on no of employees May reduce fees, defer payment and or receive admin assistance

40. European Commission Draft commission regulation on penalties regulation (4 Feb 05) - Art 84(3) Reg 726/2004 Impose fine, adopts max amounts, conditions and methods of collection Proposed guideline on definition of a potential serious risk to public health 22 Feb 05 - Dir 2001/83/EC amended 2004/27/EC) Provide examples which will NOT be a serious risk

41. European Commission Principals of GMP for AS used as a starting material 8 Mar 05 Inspection of manufacturers of AS � guidance on the grounds (triggers) for inspection 8 Mar 05 Format and content of manufacturers, importers authorisations 8 Mar 05 Format and content of the cGMP 8 Mar 05

42. European Commission Adoption of the commission proposal on the fees payable to the EMEA 4 Apr 05 Guidance concerning the Braille requirements for labelling and the package leaflet 13 Apr 05 - Art 56a Dir 2001/83/EC amended 2004/27/EC Applies 30 Oct 05 to all MA approved after that date Will not apply immediately to all products approved before that date Will be integrated into the Readability guideline

43. Heads of Agencies (HMA) Decentralised procedure MS SOP MRFG best practice guide for MR Mar 05 MRFG WP on variety of topics Implementation of new legislation meeting � HMA + EMEA + EC New co-ordination group for MR and DP � CMD (formerly MRFG) Started informally Apr 05 Consider implementation of DP

44. Heads of Agencies Benchmarking of European Medicines Agencies (BEMA) Self assessment then peer review visit HMA paper on strategy on the future European Medicines Regulatory Network adopted for drafting full document Communication, info, scientific resources, assessment process, PV, inspection and lab control, enforcement, IT info, availability of medicines

Review of Legislation 2001

Review of Legislation 2001

Presentation Transcript

Heritage Legislation- A Review

Performance Review H1-2000-2001

Review on expenses 1997 - 2001

2001 Market Review

REVIEW OF DELEGATED LEGISLATION IN CANADA: ROLE OF THE LIBRARY

Legislation

BES Review of NSLS July 11-13, 2001

Review of Legislation and Impact on Public Libraries

Purposes of Legislation

Biosimilars 2009 Update Pending Legislation Review

Exam Review of Cache Memories Dec 11, 2001

2001 Intergovernmental Fiscal Review Housing

Global Business Review 2001

NICC Review 2001

Performance Review H1-2000-2001

Legislation review

ISOC’s 2001 Budget Review

QUARTERLY REVIEW June 13, 2001

Review of Employment Legislation 2011/12

Legislation review