1. World Health Organization
8 November, 2018
WHO Essential Medicines and Health Products Department
Update July – Dec. 2015
IPC Meeting, WHO HQ, Geneva December 10-11, 2015
Kees de Joncheere

2. EML 2015: Full report available
586 pages, 1082 references

3. Essential Medicines List 2015
77 applications and a few big challenges:
Cancer drugs: a large comprehensive review was commissioned (29 applications)
New highly effective HCV drugs (new direct antiviral, single agents and combinations, IFN free regimens)
MDR-TB drugs (4) and 1 for TB prophylaxis
Rejections: New oral anticoagulants (NOACs), polypill, ranibizumab

4. World Health Organization
8 November, 2018
Access to medicines and technologies
Pricing and HTA:
“WHO 2015 Global Survey on Health Technology Assessment by National Authorities” Survey undertaken in response to WHA Resolution on ‘Health intervention and technology assessment in support of UHC’ who called WHO Secretariat to assess the status of HTA globally.
Report “Developing an approach for using health technology assessments in reimbursement systems for medical products”:
Meetings July + Nov 2015, setting HTA agenda
Fair pricing forum, planned for 2016
High priced medicines
shortages

5. Access to medicines and technologies
Access to Controlled Medicines:
37th Expert Committee on Drug Dependence (ECDD) held in Geneva November Review of a number of substances with potential for dependence, abuse and harm to health, it makes recommendations to the UN Secretary-General, on the need for and level of international control of these substances.
WHO recommends against international control of ketamine.

6. Efforts towards pharmacopoeial convergence facilitated by WHO
WHO Expert Committee on Specifications for Pharmaceutical Preparations (ECSPP)
Efforts towards pharmacopoeial convergence facilitated by WHO
6th INTERNATIONAL MEETING OF WORLD PHARMACOPOEIAS
co-hosted by SFDA/ChPC, Su Zhou, China – September 2015
7th INTERNATIONAL MEETING OF WORLD PHARMACOPOEIAS
co-hosted by MHLW/PMDA/JP, in Tokyo, Japan September 2016
New Guidance documents adopted by the 50th WHO Expert Committee ECSPP
 Finalization of main Good Pharmacopoeial Practices (GPhP)

7. The International Pharmacopeia 2015
5th Edition of Ph.Int. Just Published in press! Online version:

8. 66th WHO Expert Committee on Biological Standardization (ECBS) New Guidance documents adopted
Title
Brief description
Weblink (URL)
WHO Guidelines on Good Manufacturing Practices (GMP) for Biological Products (Revised)
Major revision. Biocontainment now included for products like poliovirus vaccines.
WHO Guidelines on Stability Evaluation of Vaccines for use under Extended Controlled Temperature Conditions (New)
Describes stability evaluation of a specific vaccine when exposed to a planned short term temperature excursion outside the cold chain immediately prior to administration. Avoids off-label vaccine use.
WHO Recommendations to assure the Quality, Safety and Efficacy of Recombinant Human Papilloma Virus-like Particle Vaccines (Revised)
Revision covers use of immunological endpoints; development of HPV vaccines with extended valency; plus likely entry of new products into the market.
Regulatory assessment of approved rDNA-derived biotherapeutics , Addendum to: WHO TRS 987, Annex 4 (New)
Regulatory assessment of biotherapeutics licensed with data that do not comply with current international regulatory standards for biotherapeutic products including biosimilars.

9. WHO Prequalification
CPH meeting overview
Joint UNFPA-UNICEF-WHO meeting with manufacturers and suppliers of contraceptive devices, in vitro diagnostics, vaccines, finished pharmaceutical products and active pharmaceutical ingredients
Forum at which manufacturers, quality, safety and efficacy experts, procurement agencies, and international donors working in public health, come together to discuss issues around production and supply for vulnerable populations
Disease updates
Presentations of treatment guidelines & market trends
Child health
Reproductive & maternal health
HIV/AIDS, Hepatitis B & C
Tuberculosis
Malaria
Hot topics
Data integrity
Viable commercial environment
Regulatory advice
Technical updates
Prequalification of MCDs, IVDs, vaccines, FPPs, and APIs
Product evaluation for urgent need
Collaborative procedure for accelerated registration
One-to-one
Meetings between technical teams and manufacturers
WHO prequalification
WHO/UNFPA prequalification
Procurement
WHO Prequalification of IVDs, vaccines, FPPs, and APIs
WHO/UNFPA Prequalification of MCDs

10. Collaborative procedure
WHO Prequalification
CPH meeting overview
Joint UNFPA-UNICEF-WHO meeting with manufacturers and suppliers of contraceptive devices, in vitro diagnostics, vaccines, finished pharmaceutical products and active pharmaceutical ingredients
357 participants
70 % industry
30% WHO, UN & partners
37 countries
121 one-to-one meetings Vx Rx Dx
Assessment
Inspection
Technical assistance
Collaborative procedure
Highlight! A new app to:
Consult the agenda and speakers
Network with attendees
Ask questions during the meeting
Participate in polls
Answer surveys at the end of each presentation

11. World Health Organization
8 November, 2018
Safety and Vigilance
Steering Committee meeting of the Member State Mechanism on SSFFC Medical Products (September, Geneva)
Region of the Americas Workshop on Surveillance and Monitoring of SSFFC medical products (October, Buenos Aires)
Full meeting and technical meetings of the Member State Mechanism on SSFFC Medical Products (November, Geneva)
Medical Product Alerts issued 2015: falsified contraceptive, meningitis vaccine, diazepam
38th Annual Meeting of Representatives of the National Pharmacovigilance Centres participating in the WHO Programme for International Drug Monitoring, November 2015 in New Delhi, India

12. World Health Organization
8 November, 2018
Regulatory System Strengthening; NRA Assessment Tool
2nd International Consultation (Nov 2015) outcomes:
Support for categorizing regulatory systems according to levels of maturity/performance
Support for a single WHO benchmarking tool and policy for use by the WHO and/or other organizations that allows for use across product lines (considering smooth transition from current to global tool)
Support for WHO efforts to promote a more strategic, effective and coordinated approach to regulatory system strengthening through a coalition of trusted technical partners
Support for an abridged tools of regulatory systems benchmarking that takes account the work done by other organizations
Recognition that reliance/cooperation is increasingly important in helping to fulfill regulatory mandates

13. Local Production
Technical meeting of Pharmaceutical Manufacturing Plan for Africa facilitated, under the auspices of the AUC
On the occasion of the international conference on financing for development in Addis Ababa, Launch of Ethiopia’s National strategy and Plan of Action for Pharmaceutical manufacturing (July 2015): high level representation Prime Minister, Heads of Int. Agencies and WHO DG.
WHO Publication on “Cuban experience with local production of medicines, technology transfer and improving access to health”.
Global Conference on Assistive Devices & Technology: ASEM Plus in Beijing, Oct 2015.

14. R&D Blue Print
Leveraging lessons learnt for an effective R&D preparedness strategy
Developing and implementing a roadmap for R&D preparedness for priority pathogens.
Enabling roll-out of an emergency R&D response as early and as efficiently as possible. (Better readiness to promptly conduct R&D during an emergency.)

15. 1 2 3 4 5 R&D Blue Print Five work-streams
designed to identify key actions required to accelerate access to products 1
Prioritisation of pathogens & operational plan 2
Identification of research priorities 3
Coordination of stakeholders & expansion of capacity 4
Assessment of preparedness and impact of intervention 5
Development of innovative funding options