who prequalification team vector control products ... · microsoft powerpoint - introduction who...

WHO PREQUALIFICATION TEAM

WHO Prequalification Team

Vector Control Products Assessment Group

Workshop on Dossier Requirements and Proposed Inspection Protocol

26-28 October 2016, Geneva, Switzerland


Recall: WHO leadership is strongly committed to vector control reform

Quotes from selected members of WHO leadership

WHO has initiated ambitious reforms in

response to needs of vector control community

� WHO recognizes the need for reformsregarding evaluation of innovative tools, improving quality in the system, standardized

vector control evaluation and timely

development of normative guidance, etc.

� To support the development, evaluation,

quality control, adoption, and sound

management of pesticides, a detailed plan for the WHO transformation was presented at the June I2I convening

� Since then, WHO has been awarded 2 grants based on the plan to improve

evaluation systems and procedures, and to

strengthen vector control normative functions.

� Material shown today is reflective of the progress made by NTD, GMP, and PQT towards the goals of the WHO transformation

"A global health agenda that gives higher priority

to vector control could save many lives and avert

much suffering."

"I fully support this WHO vector control change

and am looking forward to see significant progress

by the end of 2016 and celebrate success in 2017."

Margaret Chan,

Director-General WHO

"A global health agenda that gives higher priority

to vector control could save many lives and avert

much suffering."

"I fully support this WHO vector control change

and am looking forward to see significant progress

by the end of 2016 and celebrate success in 2017."

Margaret Chan,

Director-General WHO

"I2I is a really important vector control reform, in

line with WHO reforms for drugs, vaccines and

diagnostics."

Marie-Paule Kieny,

Assistant Director-General for

Health Systems and Innovation

"I2I is a really important vector control reform, in

line with WHO reforms for drugs, vaccines and

diagnostics."

Marie-Paule Kieny,

Assistant Director-General for

Health Systems and Innovation

WHO leadership clearly expressed

full support of this change

1


Transition Goals


NTD, PQT, and GMP will continue to coordinate closely throughout process for vector control product assessment and guidance

Development of manufacturing

qual. standards for product PQ

Pro

du

ct

Evaluate PH value of new

paradigm (incl. technical advice to

manufacturers)

Dev. of safety / efficacy standards

for prototype evaluation

Decision on possible

public health

benefit and

pursuing further

development

Activities

Dev. of safety / efficacy standards

for product PQ

Review of PQ dossiers and

decision on PQ listing

Manufacturing quality of PQ listing

process

On-going safety / efficacy / quality

evaluation

Utilization normative

guidance

Development of

standards

PQ product review

Post-listing

Pro

toty

pe

Transition(pre-2017)

Target(2017 - ...)

Established prod. New tools

N/A (for established

products

VCAG for new

paradigms)

NTD/GMP

N/A

NTD

(PQ consulted in

general and PQ will

have primary lead of

developing new

manufacturing

quality product

evaluation

requirements)

PQ

(NTD involved)

NTD/GMP(PQ involved)

NTD/GMP/PQ

PQ

(NTD/GMP

involved)

5


WHO reform will deliver several benefits to

all key stakeholders in the spaceFaster, clearer and more transparent vector control product

evaluation system

� Revised evaluation committee and procedures

� Data generation by manufacturers and increased emphasis on

innovation

� Stronger pre-submission guidance support to manufacturers

For

countries

More transparent global evaluation system in support of countries

and regional systems

� Stronger support to national registration through more transparent

global evaluation

� Increased support and guidance on registration, capacity

strengthening and quality controlFaster evaluation and strengthened development of normative

guidance for innovative tools

� More efficient evaluation to enable innovative tools to be available

faster to procurers

� Timely and strengthened development of normative guidance of

innovative tools and new product categoriesDecreased incidence of vector-borne disease

� Higher quality and appropriate use of effective products in the field

� Stronger support to monitor and manage resistance and life-cycle

pesticide management

For

procurers

For NRAs

For industry

1


Enhancements and New Activities

WHO PREQUALIFICATION PROGRAMME

Essential Medicines and Health Product

[EMP]

Essential Medicines and Health Product

[EMP]

Policy, Access and Use[PAU]

Policy, Access and Use[PAU]

Regulation of Medicines and other Health Technologies

[RHT]

Regulation of Medicines and other Health Technologies

[RHT]

Technologies Standards and Norms

[TSN]

Technologies Standards and Norms

[TSN]

Regulatory Systems Strengthening

[RSS]

Regulatory Systems Strengthening

[RSS]

Prequalification Team[PQT]

Prequalification Team[PQT]

Safety and Vigilance[SAV]

Safety and Vigilance[SAV]

Public Health, Innovation and

Intellectual Property[PHI]

Public Health, Innovation and

Intellectual Property[PHI]

Structure of Department of Essential Medicines & Health Products

WHO PREQUALIFICATION PROGRAMME

Structure of the Prequalification Team (before VCPAG)

Prequalification Team

Vaccines Assessment

Medicines Assessment

Diagnostics Assessment

Administrative team

InspectionsTechnical

Assistance/Labs

Coordinator’s office


PQT VCPAG Structure


Approach to Process and Workshop

New AI

for Vector

Control

JMPR

(WHO-CAGP)

SRA

VC Product

Development

PQT VCPAG

Assessment

PQT VCPAG

Inspection

Listing Maintenance

Day 1 Day 2

Day 3


Objectives

Objectives of Workshop Day 1:

1. Discuss the data needed to conduct a human health risk assessment on a new AI developed initially for vector control as opposed to agriculture.

2. Discuss the data needed to conduct an ecological risk assessment on a product which contains a new AI developed initially for vector control as opposed to agriculture.

3. Outline exposure scenarios based on product formulation type which inform necessary toxicology and exposure data.


Objectives


1. Present current approaches to product specific data requirements under WHOPES.

2. Discuss the data needed to determine quality, efficacy and safety of vector control product types.

3. Engage with stakeholders to ensure that quality and quantity of data reviewed will instil confidence in NRA regulators, procurement agencies and consumers.

4. Outline proposed process for the submission and review of proposed protocols which may differ from current study protocols due to product specific characteristics.


Objectives


1. Present proposed inspection procedures for the manufacturing and testing of vector control products.

2. Address stakeholder questions regarding the need for and process for conduction of pre- and post-market inspections.


Contacts14

Diagnostics

Irena Prat

[email protected]

Medicines

Matthias Stahl

[email protected]

Vaccines

Carmen

Rodriguez Hernandez

[email protected]

Inspections

Ian Thrussell

[email protected]

Technical assistance &

laboratories

Milan Smid

[email protected]

Prequalification team

Deus Mubangizi

PQT Coordinator


Back-up slides

15


16

� For each type of product, prequalification includes a comprehensivedossier assessment and a manufacturing site inspection, as well asother product-specific elements of evaluation

Prequalification workflow

Lab

evaluation

Dossier

submission

Screening

Assessment Inspection

CAPA

Follow-up inspection

CAPA

Prequalification decision

Pre-submission

form


17

� In addition, SRA-approved products are evaluation according to theabbreviated prequalification procedure

Prequalification workflow

Information package

submission

Screening

Assessment Inspection

Prequalification decision

Review of

SRA evaluation

documents

Lab

evaluation

NRA functionality

Programmatic suitability

Verification

of GMP/QMS

status


18

�

� Sampling & testing

� Adverse event monitoring

� Annual report review

� Reinspection

� Requalification

� Variations/changes

assessment

Ensuring the ongoing quality of prequalified products is an equallyimportant responsibility of the prequalification team

Post-PQ activities

Post-PQ validation Post-marketing surveillance

Sys

tem

ati

cT

rig

ge

red


19

� The collaborative procedure enables NRAs to accelerate theregistration of prequalified products so that they can enter localmarkets more quickly

Collaborative procedure

� Procedure in

development

� Ongoing discussions

with NRAs

Diagnostics

� WHO PQ shares the reports that served as the basis for the prequalification

decision, so that NRAs do not conduct assessment and inspections

� National registration based on PQT evaluation

� Started in 2012

As of July 2016:

� 28 countries

participating

� 165 registrations in 19

countries for 65

different products

Medicines

� Procedure published

in 2007, harmonized

for medicines and

vaccines as of 2014

In 2015:

� Adopted by expert

committee (ECBS)

Vaccines

Pri

nc

iple

s


WHO collaborative registrationsParticipating NMRAs

� ≥ 1 medicines registered

� ≥ 1 EOIs/submissions received

� No EOIs yetAs at 19 September 2016

WHO PREQUALIFICATION TEAM 21

Established acceptance by manufacturers and NMRAs

Total registrations: 162

(As at 19 September 2016)


Pipeline of applications in countries

No products registered or under review yet: Georgia, Lao PDR, Sierra Leone, Zanzibar

As at 19 September 2016

Country (when started):submissions


Time to registration(2013 – 2016 to date, n=162)

Including regulatory time and applicant time

As at 19 September 2016

who prequalification team vector control products ... · microsoft powerpoint - introduction who...

Documents