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  Nazeem Mohamed_ FEAPM_Market Access_02032018 Bonn.pptx

Nazeem Mohamed_ FEAPM_Market Access_02032018 Bonn.pptx THE AFRICAN MEDICINES REGULATORY HARMONIZATION INITIATIVE (AMRH) Nazeem Mohamed Chairman - Federation of East African Pharmaceutical Manufacturers (FEAPM) Vice Chair – Federation of African Pharmaceutical Manufacturers Ass. (...) Currently, 85% of Sub-Saharan Africa is implementing registration harmonization process AMRH Programme Overview EAC ECCAS/OCEAC SADC AMRH: Core Partners and Roles 5 EAC Medicines Regulation Harmonization Programme Launched on 30th March 2012 Purpose: Increase access to good quality, safe and effective medicines Expected outcomes: • Harmonized Guidelines and Procedures implemented by NMRAs • Integrated Information Management System (IMS) implemented • Quality Management System (QMS) implemented by all NMRAs • Regional and national capacity to implement EAC MRH • A platform for information sharing created • Framework for mutual recognition of regulatory decision developed and implemented MRH: Stepwise Approach Regional regulatory platforms Harmonized standards (technical requirements / guidelines) Joint and regional dossier assessments /GMP inspections Work sharing / pooling of resources Streamlined decision-making processes Reduced registration cycle time... ...starting with generics ...extending to other product categories (NCEs, vaccines, diagnostics) Extending to other regulatory functions over time (clinical trials, safety surveillance, etc.) Extending to other African regional blocs T h e P a th w a y 7 EAC: MRH Targets EAC guidelines implemented by year 3 Registration targets • 18 products registered through joint assessments • 75 products registered by TFDA (Tanzania Mainland), NDA (Uganda) and PPB (Kenya) • 50 products registered by ZFDB (Tanzania Zanzibar), DPML (Burundi) and MOH-PTF (Rwanda) Capacity built at NMRAs • Assessors, GMP Inspectors trained EAC Procedure for Marketing Authorization established and functional since January, 2015 32 applications received for joint assessment; 27 evaluated 23 queried and 4 products registered Joint GMP inspections conducted; 5 facilities approved Assessors & GMP Inspectors trained On going joint activities Harmonized requirements approved by Council of Ministers in Sept, 2014; • Registration, GMP and QMS • Effective from 1st Jan. 2015; • Adopted by all EAC NMRAs Centre of excellence established • MER – TFDA (TZ) • GMP – NDA (UG) • Pharmacovigilance – PPB (KE) Information Mgt System functional at TFDA Ongoing installation to other NMRAs MRH Progress to Date Approval process still lengthy, although median time down to 7 months from 12 months Joint evaluation of applications: ongoing, but slow Varied capacity in terms of infrastructure, financial and human resources among EAC RAs Poor quality dossiers and delayed/partial responses from applicants Increased cost for domestic applicants List of priority products for registration prepared by EAC and NMRAs favoured products from outside the EA region MRH: Challenges Observed Quick access to one Regional market More attractive for potential investors (40-60% reduction in approval times for foreign brands) More locally manufactured products registered (however, this is not yet the case) Joint medicinal product dossier assessments, GMP inspections and electronic submissions – saves time and scarce resources Industry responds to ONE set of queries from evaluated dossiers No need to prepare for individual NMRA’s inspection MRH: Expected Advantages Thank you

Score: 876825.9 - https://www.unido.org/sites/de...ccess_02032018%20Bonn.pptx.pdf

  1721294

ECE/TRANS/WP.29/GRVA/2020/16 proposed provisions for the same technology as in the proposal in this document, but as additional subcategory of an Emergency Steering Function. This proposal introduces the definition of a Risk Mitigation Function and the corresponding requirements. (...) It shall be possible to override the function at any time by a distinct action of the driver. 5.1.6.3.6. (...) The amendment seeks to permit such a function, aimed at reducing risks in traffic, which could so far not be type-approved. 4.

Score: 875467.8 - https://unece.org/sites/defaul...E-TRANS-WP29-GRVA-2021-13e.pdf

  B.2. COMPARABILITY A

Further hypothetical examples for illustration purposes concerning other types of international transactions are provided at Appendix 1 at the end of this Manual with a view to explaining functional analysis in a more practical manner. The situations covered in such examples are that of a manufacturing entity and of a distributor. (...) General management functions In the above example the functions addressed below are common functions that are carried out by any business irrespective of its size and type. (...) Table B.2.2: Qualitative Relative Assessment of Functions Performed (by A Co and B Co in relation to B Co’s Market) Category Level of Intensity A Co B Co Market development ® ®®® Product development ®®® ®® Manufacturing - ®®® Quality control ®® ®®® Post sales activities - ®®® General management functions Corporate strategy determination ® ®®® Finance, accounting, treasury and legal - ®®® Human resource management - ®®® B.2.3.2.17.

Score: 870037.9 - https://www.un.org/esa/ffd/wp-...rability_20161125_v7_clean.pdf

  UNIDO’s role in organization and dissemination of global industrial statistics

UNIDO’s role in organization and dissemination of global industrial statistics 1 stat.unido.org High-level seminar on the future of economic statistics in Latin America and the Caribbean UNIDO’s role in organization and dissemination of global industrial statistics Shyam Upadhyaya Chief Statistician UNIDO stat.unido.org 2 UNSD FAO UNIDO Other agencies • National accounts • Comtrade • Energy statistics Agriculture, forestry and fishery Industrial statistics: • Mining and quarrying • Manufacturing • Electricity, gas and steam supply • Water supply and remediation activities - For OECD countries UNIDO gets data from OECD Industrial statistics: • Mining and quarrying • Manufacturing • Electricity, gas and steam supply • Water supply and remediation activities - For OECD countries UNIDO gets data from OECD UN WTO - Tourism statistics, ITU – Telecommunication statistics, IMF – International financial statistics etc. (...) Share of MHT industries in total value added 4 stat.unido.org Measures of Global growth trends and competiveness of manufacturing … 7 stat.unido.org Global manufacturing growth trends in recent years 8 • Global manufacturing growth is slowing down in all country groups • Growth still persists but the pace is slower especially in industrialized economies • Global slowdown occurred amid new trade barriers that affect established order of global trade and tariff • Manufacturing products account for more than 80% of global merchandise trade 5 stat.unido.org Turning points of slowdown of global manufacturing 9 • Global growth continued till the last quarter of 2017 • China and emerging industrial economies that account for most of global growth encountered slowdown • Low growth creates new challenges to meet SDG-9 targets • Manufactured goods account for more than 80.0 percent of global commodity trade stat.unido.org Relative performance of manufacturing in Latin America 10 Manufacturing growth of Latin America compared to global growth • Manufacturing growth remains lower in Latin America compared to the global average and emerging industrial economies • After short-lived recovery MVA growth falls again in negative zone 6 stat.unido.org Performance of manufacturing in Latin America Data: UNIDO MVA Database Manufacturing overall has lower performance in Latin America exhibiting the phenomenon of Middle income trap. (...) Fragmentation of enterprise into business function units 8 stat.unido.org Industrial data availability by country stat.unido.org Methodology related problems 16 • Classification of industry – ISIC needs to be updated to reflect the new products and activities, but NSOs cannot change the database so frequently. • Statistical Unit - fragmentation of enterprise into business function units- core production unit and support service unit (design and engineering, financial, warehouse, transportation and other • Definition of activity - Outsourcing (domestic and global) gradually leading to increase of factory-less production. 9 stat.unido.org Coordination mechanism 17 Permanent institutions Statistical commission; international agencies, custodian agencies UNS and CCSA Working groups • Expert-groups (EGM for IRIS-2008, UB City Group) • Currently active – United Nations Committee of Experts on Business and Trade Statistics (UNCEBTS) Task Team on Business Dynamics, Business Demography and Entrepreneurship headed by INEGI, Mexico stat.unido.org Thank you!

Score: 868721.3 - https://www.cepal.org/sites/de...oba-industrial-statisticsl.pdf

  1          Chap

General Management Functions     In the above example the functions addressed below are common functions that are carried out by any  business  irrespective  of  its  size  and  type.  (...)      Human Resource Management Function: The HR function of each entity  is co‐ordinated  by  its management, which  is  responsible  for  recruitment, development and  training of  the personnel including the emolument structure.        15    Qualitative  relative  assessment  of  functions  performed  by  A  Co  and  B  Co with  respect  to  B  Co’s  market    LEVEL OF INTENSITY  CATEGORY  A Co  B Co  Market development  ®  ®®®  Product development  ®®®  ®®  Manufacturing  ‐  ®®®  Quality control  ®®  ®®®  Post sales activities  ‐  ®®®  General management Functions  Corporate strategy determination  ®  ®®®  Finance, accounting, treasury and legal  ‐  ®®®  Human resource management  ‐  ®®®    (b) Assets employed  5.3.2.2.11.  (...) Risk is important in the functional analysis and it should be considered together with the  functions  and  assets.   

Score: 868059 - https://www.un.org/esa/ffd/wp-...bility_20120918_v5_HC-accp.pdf

  Microsoft PowerPoint - 2 Isao Sugino.ppt

International Standards are Important International Standards Technical Regulations Technical Regulations Technical Regulations 6 ““voluntaryvoluntary”” standardsstandards ““mandatorymandatory”” // ““voluntaryvoluntary”” ““mandatorymandatory”” standardsstandards 7 For example, #1: Output voltage of telephone terminals … #2: Assignment of telephone numbers … #3: Protocols for FAX … #4: Mobile phone systems … #5: Mobile internet access … 8 Standardization activities in Japan (for ITU Standards) Up stream Contributions to ITU ITUITU ITU-R ITU-T MIC of Japan for ITU-R for ITU-T Other Committees Information and Communications Council Down stream TTC ARIB SDOs Participation 強制標準Mandatory Standards TTC標準 HATS 推進会議 電気通信事業者、放送事業者、製造業者、大学・研究機関等Operators, Manufacturers, Universities, Research Institutes, etc. (...) Overall effects on ITU & manufactures 2. Legal & national/international regulatory implications 3. (...) Measures to be take to build the necessary human- resource capacities 19 Main functions of HATS 1) Setting out programs for testing 2) Issuing testing guidelines 3) Implementing connectivity tests 4) Describing the basis for TTC Main functions of HATS 1) Setting out programs for testing 2) Issuing testing guidelines 3) Implementing connectivity tests 4) Describing the basis for TTC Types of interconnectivity testing 1) Tests conducted using only those devices that are subject to testing 2) Round robin testing on all devices 3) Terminal-to-terminal testing on real lines Types of interconnectivity testing 1) Tests conducted using only those devices that are subject to testing 2) Round robin testing on all devices 3) Terminal-to-terminal testing on real lines HATS (Harmonization of Advanced Telecommunication Systems) Conference - Non-Profit organization established in 1988 - To ensure the interconnectivity/interoperability of telecommunication equipments of different manufactures in order to give a users’ convenience. - Members: ICT manufacturers,vendors, carriers, TTC, MIC Secretariat: Communications and Information network Association of Japan (CIAJ) For the details, http://www.ciaj.or.jp/hats/e/what/about.html 20 The Interconnectivity Test Range Targeted by HATSThe Interconnectivity Test Range Targeted by HATS Original functions supported by each equipment Whole functions supported by each equipment Basic Functions → Interconnection test range (Essential functions) + (a part of Optional functions) Functions based on standard + Application and Network Layer Essential functions Optional functions Activity Expansion 21 Role of HATSRole of HATS - plans interconnectivity test - examines test method/procedure(test guideline) - builds test bed & executes interconnectivity test on round robin basis (Basically, participants share the detail test result, and share all cost per each test.) - reviews&studies test result (- release abstract of test result to press) HATS International standardITU, ISO, IETF etc.

Score: 865860.5 - https://www.itu.int/ITU-D/tech...20standardization%20policy.pdf

  Microsoft Word - Working paper5.docx

These enterprises are functioning well and are not reporting any problems. (...) The Jalal-Abad has a number of well-functioning large scale and medium scale enterprises. (...) A half of them are well- functioning enterprises with no problems. Another half is suffering from the problems like the lack of the market.

Score: 863785.6 - https://www.unido.org/sites/de...yrgyzstan-Regional_aspects.pdf

  Microsoft PowerPoint - Chapter 5 - Comparability Analysis_converted.ppt

F.A.R. analysis • Functions performed, • Assets employed and • Risks assumed October 2012 12United Nations - Geneva Meeting • Functions performed - Research and development; - Product design and engineering; - Manufacturing, production and process engineering and design work; - Purchasing and materials management and other procurement activities; - Manufacturing, production or assembly work; - Transportation, warehousing and inventory; - Marketing, advertising, publicity and distribution; - Market intelligence on technological developments; and - Intra-group services, - Managerial, - Legal, - Accounting and finance, - Credit and collection, - Training and personnel management services. • Functional analysis October 2012 13United Nations - Geneva Meeting • Assets employed - Identify the type of significant assets (used by or transferred between the associated enterprises in the course of international controlled transaction) - Tangible assets - Intangible assets Functional analysis October 2012 14United Nations - Geneva Meeting Functional analysis October 2012 15United Nations - Geneva Meeting Functional analysis - Type of risk in general (Depending on the nature of transaction) : 1. (...) Country/regional risk •To provide a clearer understanding of functional analysis and explain the chapter in a more practical manner, following are the hypothetical examples (Placed in Appendix I – Comparability) : • Part 1: Example related to Functional Analysis (Manufacturing Entity) • Part 2: Example related to Functional Analysis (Distributor) • Part 3: Functional Analysis Checklists • Part 4: Case Study based on a hypothetical Example October 2012 16United Nations - Geneva Meeting Contractual Terms of Transaction • Explicit terms •Written contracts / agreements • Implicit terms •Deduced from conduct of parties October 2012 17United Nations - Geneva Meeting Economic circumstances of the transaction • Industry analysis • General factors for performing industry analysis - Global economic trends and developments relating to the industry to which the enterprise belongs - Economic trends in each taxpayer’s country for the same industry - Market position of the enterprise and surrounding economic conditions. (...) Appropriateness of the method in the light of the nature of the controlled transaction (based upon a functional analysis), 3. Availability of reliable information (especially on uncontrolled comparables) 4.

Score: 862514.8 - https://www.un.org/esa/ffd/wp-.../2014/09/8STM_PPT_Chapter5.pdf

  Financing sources for manufacturers | UNICEF Supply Division

The database provides a range of financing options for new and growing manufacturers. Results can be filtered by organization type, sector, financing mechanism and location. (...) About this database: This database may help manufacturers operating in marginalized and “orphan” product areas and places to identify different sources of capital. (...) Network Offers guidance and support giving access to peers, technical expertise, services, possible financing sources and options through various networks.   Search function UNICEF designed the database to provide a simple search function that matches the interests, sectors, needs and purposes of new and growing manufacturers against different types of funding sources, financing mechanisms and sectors: Source type Financing mechanisms Sector Agency Bank Co-operative Company Consortium EU Institution Foundation Fund Government Network Non-governmental organization Private equity firm Programme Tool UN agency Debt Equity Ethical banking services Grant Guarantee Insurance Investment Loan Micro-finance Network/advocacy/other… Saving Social venture capital Advocacy/lobbying Agroforestry (food security) Art/culture (heritage) Climate change Democracy/human rights (land rights, empowerment, etc) Economic/business development Education Energy environment (ecology) Fair trade Governance (capacity building/training and management) Health Housing Infrastructure (transport, community facilities) Innovation miscellaneous (non-specified sectors focused on broader aims and principles) Research and development Technology Water and sanitation The current list serves as an initial catalogue.

Score: 859341.8 - https://www.unicef.org/supply/...inancing-sources-manufacturers

  141 CHAPTER Services

But statistics on business functions have only recently started to be collected in some national surveys (Sturgeon and others 2013).9 Alternatively, labor force surveys can be used to identify business functions by matching occupation classifications to business functions (Timmer, Stehrer, and de Vries 2015). (...) All other business functions are classified as support activities (or secondary busi- ness functions) and can be regarded as services activities if they would be classified as services if outsourced. (...) Illustrating how relevant this omission can be, Miroudot (2016) matched occupation classifications and business functions for 37 countries over 1995–2013. This decomposition of jobs embodied in manufacturing according to business function by industry reveals considerable variation across industries, with employment in core activities (operations) at more than 90% in agriculture, but at only about 33% in coke and petroleum (figure 6.7).

Score: 858762.5 - https://www.wto.org/english/re.../gvcs_report_2017_chapter6.pdf