Home

  Microsoft Word - WTACCAFG5A1_LEG_8

Packaging of Products Article 8: Companies producing medicine and all medical Appliances are under obligation to write the following issues on their products packages: 1. (...) If it has the documents proving use of its products by consumers outside of the manufacturing country and export of its products to at least one more country. 7. (...) Such a list shall be provided in a written form and shall include information such as quantity, batch no., production and expiration dates. Chapter Four Wholesale of Medicine and Medical Appliances Conditions on Wholesale License Article 46: (1) A license of wholesale of medicine and all medical Appliances is given to a natural or legal individual with the following criteria: 1.

Score: 826045.9 - https://www.wto.org/english/th..._e/afg_e/WTACCAFG5A1_LEG_8.pdf

  Promoting Access to Medical Technologies and Innovation: Intersections between public health, intell

To effectively combat SF medical products, regulatory intervention may be required, whereas the approach to falsified or counterfeit medical products may involve criminal investigation (see Chapter II, section B.1(f) and Chapter IV, sections A.12 and C.3(h)). (...) While estimates vary of the actual cost of medical research and product development, innovation is undoubtedly costly and time consuming. (...) Trade policy and the economics of global production systems are also key factors in strategic plans to build domestic production capacity in medical products.

Score: 824172.1 - https://www.wto.org/english/re...ummary_who-wipo-wto_2020_e.pdf

  237 Annex 10 Good re

Scope The document covers reliance activities in the field of regulation of medical products (i.e. medicines, vaccines, blood and blood products and medical devices including in-vitro diagnostics), addressing all the regulatory functions in the full life cycle of a medical product, as defined in the Global Benchmarking Tool (5): registration and marketing authorization, vigilance, market surveillance and control, licensing establishments, regulatory inspection, laboratory testing, clinical trials oversight and NRA lot release. (...) The concept of reliance covers all types of medical products and regulatory activities. Reliance approaches should be given consideration in 242 W H O T ec hn ic al R ep or t S er ie s, N o. 1 03 3, 2 02 1 WHO Expert Committee on Specifications for Pharmaceutical Preparations Fifty-fifth report particular for medical products for priority diseases for which there are unmet medical needs, medical products to be used in public health emergencies or during shortages and also for orphan and paediatric medical products. 4. (...) Work-sharing and joint activities are examples of mutual reliance. 5.3 Life cycle approach The concept of reliance for regulation of medical products should be applied throughout the life cycle of medical products and in all regulatory functions (see 3.

Score: 823435.5 - https://www.wto.org/english/tr...chsymp_290621/gaspar_pres3.pdf

  Microsoft Word - Guideline-AI-Medical-Devices_EN.docx

The safety of medical products must be considered in all phases of the product life cycle processes. (...) One hopes that standards for the safety of AI-based medical products will be developed and harmonized. (...) For this reason, there can be no set list of “controls” for medical products. The manufacturer's intended use of the product is critical. 10.

Score: 823112.4 - https://www.itu.int/en/ITU-T/f...ments/all/FGAI4H-H-034-A01.pdf

  The Global Advisory Committee on Vaccine Safety

Countries face a range of obstacles to achieving this, including rising prices for new medicines; shortages and stock outs of essential medicines, especially for noncommunicable diseases, and the growing problem of substandard and falsified medical products entering the global supply chain. (...) Browse   Our work All → Supporting the quality and safety of blood products Strengthening medical imaging Strengthening access to essential medicines Standardizing biotherapeutic products Providing International biological reference preparations Promoting rational use of medicines Promoting national medicines policies Prioritizing medical devices Improving access to Assistive Technology Technical information Access to assistive technology & medical devices INN and classification of medical products (INN) Medicines Selection, Intellectual Property and Affordability Technical Standards and specifications Local Production & Assistance Regulation and safety Expert committees The Global Advisory Committee on Vaccine Safety Q&A's The WHO Essential Medicines List Antibiotic Book The WHO Essential Medicines List Antibiotic Book Medicines: WHO policy and approach towards building and strengthening regulatory capacity for medical products Medicines: WHO policy and approach towards building and strengthening regulatory capacity for medical products Coronavirus disease (COVID-19): Use of Emergency Use Listing procedure for vaccines against COVID-19 Coronavirus disease (COVID-19): Use of Emergency Use Listing procedure for vaccines against COVID-19 Multimedia All → 21 December 2020 Getting vaccines, medicines and tests ready for emergency use 29 July 2020 Promoting Access and Medical Innovation Publications All → 28 January 2022 WHO Drug Information - Volume 35, No. 4 Download Read More 27 January 2022 The Selection and Use of Essential Medicines (2021) - TRS 1035 The 23rd meeting of the WHO Expert Committee on Selection and Use of Essential Medicines was coordinated from Geneva, Switzerland, and held virtually from... (...) Download Read More Events 25 April – 2 May 2022 56th Expert Committee on Specifications for Pharmaceutical Preparations Access to Medicines and Health Products 13 December 2021 13:00 – 14:30 CET Webinar: Medical devices nomenclature mapping 18 November 2021 13:00 – 14:00 CET The WHO Essential Medicines List Antibiotic Book 21 October 2021 10:00 – 13:00 WAT Webinar: Evidence-Based Selection of Essential In-Vitro Diagnostics, Priority Medical Devices and Assistive Products to Accelerate Progress towards Universal Health Coverage in WHO African Region Related health topics All → Health interventions Assistive technology Substances Biologicals Physiological interventions Blood products Health interventions In vitro diagnostics Socio-political determinants Intellectual property and trade Health interventions Medical devices Health interventions Medicines Other Oxygen Health systems Substandard and falsified medical products Health interventions Transplantation Regions Africa Americas Eastern Mediterranean Europe South-East Asia Western Pacific Policies Cyber security Ethics Permissions and licensing Preventing sexual exploitation Terms of use About us Careers Library Procurement Publications Frequently asked questions Contact us Subscribe to our newsletters Privacy Legal Notice © 2022 WHO

Score: 822760.7 - https://www.who.int/our-work/a...ry-committee-on-vaccine-safety

  Promoting Access to Medical Technologies and Innovation: Intersections between public health, intell

Regulation of health technologies 52 (a) Why regulate medical products? 53 (b) Clinical trials 54 (c) Research ethics 54 (i) Clinical trial ethics 54 (ii) Health databases and biobanks 55 (iii) Bioethics 55 (d) Biotherapeutic products 56 (i) Background 56 (ii) Pathways for the registration of biotherapeutic products 56 (iii) What will be the effect of SBPs on prices? (...) Registration of clinical trials in pharmaceutical product development 148 c. overcoming market failures in medical product r&d 151 1. (...) Substandard and falsified (SF) medical products 214 (a) Types of SF medical products 214 (b) Counterfeit medical products and the TRIPS Agreement 215 (c) The impact of SF medicines 215 (d) How can SF medical products be combated?

Score: 822077.9 - https://www.wto.org/english/re...ntents_who-wipo-wto_2020_e.pdf

  Restrictions on the export of medical products hamper efforts to contain coronavirus disease (COVID-

Editorial: ECLAC May 2020 Download Publication pdf Description Latin America and the Caribbean is highly dependent on imports of medical products, as less than 4% of these are sourced within the region itself. To date, more than 70 countries —including four of the region’s top five suppliers, of which the first is the United States— have restricted their medical exports in response to COVID-19. Export restrictions are hampering the supply of products essential for fighting the pandemic in the region. Latin America and the Caribbean should make it a strategic objective to strengthen its productive capabilities in the pharmaceutical and medical supplies and equipment industries, in order to gain a less vulnerable footing to face health crises in the future.

Score: 821100 - https://www.cepal.org/en/publi...ts-contain-coronavirus-disease

  Access to Medicines and Health Products 

Countries face a range of obstacles to achieving this, including rising prices for new medicines; shortages and stock outs of essential medicines, especially for noncommunicable diseases, and the growing problem of substandard and falsified medical products entering the global supply chain. (...) Browse   Our work All → Supporting the quality and safety of blood products Strengthening medical imaging Strengthening access to essential medicines Standardizing biotherapeutic products Providing International biological reference preparations Promoting rational use of medicines Promoting national medicines policies Prioritizing medical devices Improving access to Assistive Technology Technical information Access to assistive technology & medical devices INN and classification of medical products (INN) Medicines Selection, Intellectual Property and Affordability Technical Standards and specifications Local Production & Assistance Regulation and safety Expert committees The Global Advisory Committee on Vaccine Safety Advisory Group meeting on fair pricing Expert Committee on Selection and Use of Essential Medicines Expert Committee on Biological Standardization Expert Committee on Drug Dependence Expert Committee on Specifications for Pharmaceutical Preparations (ECSPP) Q&A's The WHO Essential Medicines List Antibiotic Book The WHO Essential Medicines List Antibiotic Book Medicines: WHO policy and approach towards building and strengthening regulatory capacity for medical products Medicines: WHO policy and approach towards building and strengthening regulatory capacity for medical products Coronavirus disease (COVID-19): Use of Emergency Use Listing procedure for vaccines against COVID-19 Coronavirus disease (COVID-19): Use of Emergency Use Listing procedure for vaccines against COVID-19 Multimedia All → 21 December 2020 Getting vaccines, medicines and tests ready for emergency use 29 July 2020 Promoting Access and Medical Innovation Publications All → 28 January 2022 WHO Drug Information - Volume 35, No. 4 Download Read More 27 January 2022 The Selection and Use of Essential Medicines (2021) - TRS 1035 The 23rd meeting of the WHO Expert Committee on Selection and Use of Essential Medicines was coordinated from Geneva, Switzerland, and held virtually from... (...) Download Read More Events 25 April – 2 May 2022 56th Expert Committee on Specifications for Pharmaceutical Preparations Access to Medicines and Health Products 13 December 2021 13:00 – 14:30 CET Webinar: Medical devices nomenclature mapping 18 November 2021 13:00 – 14:00 CET The WHO Essential Medicines List Antibiotic Book 21 October 2021 10:00 – 13:00 WAT Webinar: Evidence-Based Selection of Essential In-Vitro Diagnostics, Priority Medical Devices and Assistive Products to Accelerate Progress towards Universal Health Coverage in WHO African Region Related health topics All → Health interventions Assistive technology Substances Biologicals Physiological interventions Blood products Health interventions In vitro diagnostics Socio-political determinants Intellectual property and trade Health interventions Medical devices Health interventions Medicines Other Oxygen Health systems Substandard and falsified medical products Health interventions Transplantation Regions Africa Americas Eastern Mediterranean Europe South-East Asia Western Pacific Policies Cyber security Ethics Permissions and licensing Preventing sexual exploitation Terms of use About us Careers Library Procurement Publications Frequently asked questions Contact us Subscribe to our newsletters Privacy Legal Notice © 2022 WHO

Score: 820728.1 - https://www.who.int/our-work/a...-medicines-and-health-products

  Promoting access to medical technologies and innovation Intersections between public health, intelle

Trade policy and the economics of global production systems are also key factors in strategic plans to build domestic production capacity that aim for better access to medical products. (...) As technology evolves, more combination products materialize – mainly in the area of medicines in medical devices delivery sets. (...) For example, regulation of medical products is an integral part of the access equation.

Score: 818286.9 - https://www.wto.org/english/tr...web_e/ch1d_trilat_web_13_e.htm

  PowerPoint Presentation

PowerPoint Presentation © UNICEF/Lister Anthropometric Equipment: Procurement Update Rob Matthews Health Technology Centre November 5th 2019 Presentation Overview • Commodity Portfolio shift from the Medicines & Nutrition Centre (MNC) to the Health Technology Centre (HTC) • Introduce the Medical Device Unit (MDU) • HTC Procurement approach for Medical Devices • Tender Overview and Outcome 2 • Product Portfolio review undertaken as part of the 4 year Strategic Plan (OMP 2018 – 2021) • Anthropometric Equipment reallocated under HTC following Realignment of Products within Technical Expertise Areas Commodity Portfolio shift from MNC to HTC Anthropometric Equipment: Procurement Update – UNICEF | for every child3 Health Technology Centre – Supply Division Health and Technology Centre Abdallah Makhlof– Chief Malaria Prevention and Diagnostics Unit Lama Suleiman – Contract Manager Medical Devices Unit Robert Matthews – Contract Manager Cold Chain Unit Thomas Sorensen – Senior Contract Manager SUPPLY DIVISION Etleva Kadilli – Director SUPPLY PROGRAMMES Hanne Bak Pedersen– Deputy Director Medical Devices Unit Product Portfolio • Safe Injection Devices: • Auto-Disable Syringes for immunization • Re-Use Prevention, and Disposable syringes • Safety boxes and Biomedical waste incinerators • Hospital and Medical Equipment, Hospital Furniture • Neonatal Intensive Care Unit Equipment • Obstetric care and Post-partum care of the mother • Oxygen Systems • Anthropometric Equipment • Emergency Health Kits, • Personal Protective Equipment (PPE) • Standard Kits, Country specific kits Demand Profile by Material Group • Safe Injection Equipment • Emergency response • Kit packing • Specific Projects • General Medical requests + Anthropometric Equipment Demand Profiling – Demand for MDU products 700+ procured by SD MDU in 2013-2017 period. 10 products make up 50% of the procurement value. (...) LTAs with less than 10 items (Out of those 25 LTAs with only 1 material) • 72 different suppliers – High supplier management workload (Average 1.6 LTAs per supplier) • 53% USD value (2013-2018 ZPOX) • 3 tenders. 1 Principal Tender, 2 ad hoc • Number of materials per LTA • Average: 4.8 materials per LTA • One LTA with 15 items, rest below 10 items (3 LTAs with only 1 item) • 9 different suppliers (Average 1.4 LTAs per supplier) • 47% USD value (2013-2018 ZPOX) As at April 2018 406 Materials description 116 LTAs 63 Suppliers 21 Countries 813 Contracts lines 46 Materials groups Medical Equipment Supply Agreements: 2017 Outcome Source ZLTAM, As at April 2018 Materials Management • Review of Existing Materials • Simplifying the Materials Grouping & cleaning the Material Master Parameters considered when establishing a new Tender Schedule Reviewing the full range of products, considering: • Number of Products per Tender • Value of Products (prior procurement value) • Priority Product groups • Scope of products • Market Development of the product – Stable or Innovative? (...) • Product Risk (to recipient/use) and complexity • Program area of the product • Demand profile (Warehouse, Direct shipment, DOA) • Demand profiles in terms of volumes and order frequency • Historic sourcing of products – manufacturer or wholesaler • Supplier catalogues • ….

Score: 817937.45 - https://www.unicef.org/supply/...uipment-Procurement-Update.pdf