Accelerating access to quality assured health products

WHO collaborative registration procedure

07/04/2019| Title of the presentation 1

Dr. Luther Gwaza, Technical Officer

WHO/EMP/RHT/RSS, Email: gwazal@who.int

Vector control:2017

WHO Prequalification

Vaccines 1987

In vitro

Diagnostics 2010HIV test kit evaluation

1988

Medicines 2001

WHO Pesticide Evaluation

Scheme (WHOPES) was set

up in 1960

Source: http://www.who.int/immunization_standards/vaccine_quality/progress_report_who_pqp_june2013.pdf?ua=1

3

65% of children globally are immunized with WHO prequalified vaccines through the GAVI alliance

PEOPLE ON ANTIRETROVIRAL THERAPY ACROSS THE GLOBE ARE TREATED WITH WHO PREQUALIFIED GENERIC MEDICINES

4

How do WE get the prequalified product to these

patients faster, and more efficient?

How do WE ensure continued supply of quality

assured products post-registration?

Applicable guidelines for CRP

http://apps.who.int/iris/bitstream/handle/10665/25533

8/9789241209960-eng.pdf?sequence=1

WHO Technical Report Series 996, 2016

Collaborative Procedure provides an avenue for

the NRAs to reduce regulatory burden and duplication,

promote efficient use of resources by re-allocating resources to high-risk products and manufacturing sites.

CRP Timeline

2004/5: Expedited

review procedure

for vaccines.

2012: pilot CRP started

for medicines

2015: Pilot SRA

collaborative procedure.

2016: Medicines

and vaccines CRP merged

2018: Approval and publication of

the SRA CRP

guideline

Next: pilot CRP for

diagnostics

Next: pilot CRP for vector control

products

How does the PQ collaborative procedure works?

WHO PQ Process

Assessment of Dossier

Inspections

(API, FPP, CRO)

List of Prequalified

products

INPUTS PROCESS OUTPUTS

Assessment/

Inspection/Lab

Reports

WHO Public

Reports

Dossier

Expression

of Interest

Assessors/

Inspectors

WHO Guidelines

Testing

Marketing

authorisation

Submission

NRAWHO

PQ

KEY Principles of WHO PQ CRP

• Voluntary

• Product and registration dossier in countries are 'the same' as prequalified by WHO.

• Shared confidential information to support NRA decision making in exchange for accelerated registration process

• 'Harmonized product status' is monitored and maintained

4/7/2019 | Title of the presentation 12

Sameness of products

1. the same product dossier;

2. the same manufacturing chain, processes, control of

materials and finished product, and in the case of vaccines

also by the same batch release scheme;

3. the same active ingredient and finished product

specifications;

4. the same essential elements of product information for

pharmaceutical products, in the case of vaccines by the

same product information, packaging presentation and

labelling.

07/04/2019 13

PQ NRA

Options for participating regulators

• Recognize = Verify

• Reliance =

• abridged reviews

• Organize R/B second review and inspections

• Consider in decision making

• Use as quality assurance of national assessment and decision

• Conclude differently from WHO PQ - justify

• Benefit from shared information for harmonization

and training BUT

•Accelerate the national decision

14

Defining Reliance and Recognition

▪Reliance: act whereby a regulatory

authority in one jurisdiction may take

into account/give significant weight to

work performed by another regulator

or other trusted institution in reaching

its own decision.

▪Recognition: the routine

acceptance of the regulatory decision

of another regulator or other trusted

institution. Recognition indicates that

evidence of conformity with the

regulatory requirements of country A

is sufficient to meet the regulatory

requirements of country B.

Stage 3:

Post-Approval

changes

Prequalified Product

(PQ’ed) + NMRA

registered product

WHO PQ removes

product from list

published in line with

this procedure

NO

Deviation Significant

deviations

NMRA decides

within 30 days &

inform PQ if any

deviations

(Appendix 4)

Product remains on the

WHO list published in

line with this procedure

Major variation (requires approval

before implementation) to a

PQ’ed & NMRA registered

product

PQ assess the variation &

share assessment

outcomes with participating

NMRA

NMRA perform abridged

review using the WHO

PQ outcomes

Manufacturer submits the

PQ approved variation +

updated documents to

NMRA

Manufacturer submits the

variation to PQ for

assessment

Win-win outcomes for all stakeholders

• Manufacturers

• Harmonized data for PQ and national registration

• Facilitated interaction with NRAs in assessment, inspections

• Accelerated and more predictable registration

• Easier post-registration maintenance

• Procurers

• Time, assurance, availability

Win-win outcomes for all stakeholdersNMRAs

• Having data well organized in line with PQ requirements

• Availability of unredacted WHO assessment and inspection outcomes

to support national decisions and save internal capacities

• Having assurance about registration of 'the same' product as is

prequalified (in this case, US FDA approved/tentatively approved

products)

WHO

• Prequalified products are faster available to patients

• Feed-back on WHO prequalification outcomes

18

19

Current CRP Status by Product Stream

WHO PQ CRP Status update: Medicines

https://extranet.who.int/prequal/content/collaborative-registration-faster-registration

Participating NMRAs

Armenia

Botswana

Burkina Faso

Burundi

Cameroon

*Caribbean Community

(CARICOM)

Cote d'Ivoire

Dem. Rep. Congo

Eritrea

Ethiopia

Pakistan

Philippines

Senegal

Sierra Leone

South Africa

Sri Lanka

Tanzania

Thailand

Uganda

Ukraine

Zambia

Zanzibar

Zimbabwe

As at 10 Oct 2018

* CARICOM

Member States: Antigua and Barbuda, Bahamas, Belize, Dominica, Grenada, Haiti, Jamaica,

Montserrat, Saint Lucia, St. Kitts and Nevis, St Vincent and the Grenadines, Suriname and Trinidad

and Tobago

Associate Member States: Anguilla, Bermuda, British Virgin Islands, Cayman Islands and Turks

and Caicos Islands

Georgia

Ghana

Kazakhstan

Kenya

Kyrgyzstan

Lao PDR

Madagascar

Malawi

Mali

Mozambique

Namibia

Nigeria

Country registrations & therapeutic area

Total registrations: 380(As at 10 Oct 2018)

15

36

61

81

123

63

6 12 15 16 20 130

20

40

60

80

100

120

140

2013 2014 2015 2016 2017 2018

Registrations Countries

205

76

52

34

63

21

Therapeutic categories of registered medicines

HA

TB

MA

RH

NT

DI

HP

IN

Pipeline of applications in countries

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

As at 10 Oct 2018

Country (when started):

No of submissions

0 20 40 60

Philippines (Mar-16)

Nigeria (May-13)

Zimbabwe (Nov-12)

Zambia (Jul-14)

Tanzania (Oct-13)

Ethiopia (Apr-14)

Botswana (May-14)

Ghana (May-13)

Mozambique (Jan-16)

Burundi (Jul-16)

Malawi (Sep-15)

Ukraine (Jan-14)

Mali (Feb-16)

Uganda (Nov-12)

Namibia (May-13)

CARICOM (Feb-17)

DRC (Jan-16)

Kenya (Dec-12)

Kyrgyzstan (Sep-14)

Armenia (Jun-16)

Madagascar (Jan-15)

Cameroon (Jan-15)

Senegal (Apr-16)

Registered

Under review

Dossier awaited

As at 10 Oct 2018

Company (when started)

No of applications

Pipeline of applications, by company

0 20 40 60 80 100 120 140 160 180 200 220

Macleods Pharmaceuticals Ltd (Jan-14)

Strides Shasun Limited (Mar-15)

Cipla Ltd (Jan-14)

Hetero Labs Limited (May-13)

Jai Pharma (formerly: Famy Care Ltd) (Nov-12)

Hetero Labs Ltd (Mar-17)

Ajanta Pharma Ltd (May-15)

Mylan Laboratories Ltd (Nov-12)

Shanghai Dahua Pharmaceutical Co Ltd (Nov-…

MSN Laboratories Private Limited (n/a)

Cipla Ltd, Cipla (May-17)

Strides Shasun Ltd (Oct-17)

Strides Pharma Global Pte Ltd (Apr-16)

Acme Formulation Pvt. Limited (Mar-17)

Registered

Under review

Dossier awaited

As at 10 Oct 2018

*Including regulatory time and applicant time

Median time to registration

Days

81

93

78 75

93

7883

0102030405060708090

100

Days*