1 regulatory capacity building and principles of collaboration procedure between the who...

1

Regulatory capacity building and Regulatory capacity building and principles of Collaboration Procedure principles of Collaboration Procedure

between the WHO Prequalification between the WHO Prequalification Programme and NMRAsProgramme and NMRAs

Milan SmidWHO Prequalification of Medicines Programme

3

Outcomes of survey organized Outcomes of survey organized during the PQP Assessment training during the PQP Assessment training

January, 2011January, 2011

Copenhagen, Jan 19, 2012

4

Regulatory approvals of PQ medicines in selected countries

18 medicines selected, 18 countries participated, March 2011

0

2

4

6

8

10

12

14

16

18

20

Armen

ia

Belar

us

Botsw

ana

Cuba

Ethio

pia

Geo

rgia

Gha

na

Kenya

Moza

mbiq

ue

Namib

ia

Om

an

Saudi A

rabia

Sudan

Tanza

nia

Thaila

nd

Uganda

Zambia

Zimba

bwe


5

CTD format of dossier is mandatory or accepted


6

Current content of registration dossier for API (Drug Substance) is identical or close to CTD


7

Current content of registration dossier as regards FPP requirements (Drug Product) is

identical or close to CTD


8

Requirements on documentation of bioequivalence (concerning both demonstration

of bioequivalence in vivo and in vitro) are in principle close to PQP


9

Average length of registration assessment report (pages)

• Ghana • Kenya • Tanzania • Uganda • Zambia • Zimbabwe

Avg pages: 9.6

• Armenia • Belarus • Cuba• Ethiopia• Georgia • Mozambique • Namibia • Oman • Saudi Arabia • Sudan • Thailand


10

Average length of registration assessment report (pages)


Avg pages: 19.5

• Armenia • Belarus • Cuba• Ethiopia• Georgia • Mozambique • Namibia • Oman • Saudi Arabia • Sudan • ThailandAvg pages: 4.2


11

If special confidentiality arrangements are achieved, assessment reports are or could be made available to other regulatory authorities


12

Do you utilize WHO Public Assessment Reports (WHOPARs) in support of taking decision about

national registration


13

GMP standard required by country regulations for manufacturers of finished dosage forms is

equivalent to WHO or PIC/S GMP


14

GMP inspections of manufacturers abroad are performed


15

In case that GMP inspections of manufacturers abroad are organized, inspections are also

performed in countries with stringent regulatory authorities


16

Average length of GMP inspection report (pages)


Avg pages: 10.4

• Armenia • Belarus • Cuba• Ethiopia• Namibia • Oman • Saudi Arabia • Sudan • Thailand


17

Inspection reports are available for each inspected manufacturer


18

If special confidentiality arrangements are achieved, inspection reports are or could be made

available to other regulatory authorities


19

WHO Public Inspection Reports are regularly used as a source of information on GMP compliance,

when planning inspections of manufacturers


20

In the practice of your authority, does exist the difference between registration process of medicines, which are WHO prequalified or approved by stringent

authorities, and other medicines?


21

Does any publicly available document exist explaining the difference


22

Can you demonstrate that prequalification has positive effect on duration of a national registration procedure in your country


23

Collaboration Procedure between Collaboration Procedure between the WHO Prequalification the WHO Prequalification Programme and NMRAsProgramme and NMRAs


24

Background reasoning Background reasoning • Although WHO prequalified medicines are thoroughly

assessed and manufacturers are inspected according to WHO/international standards, to be used in recipient countries they have to be registered by NMRAs

• Registration may be facilitated by closer co-operation among WHO, NMRAs and manufacturers of prequalified medicines

• Prerequisite of facilitated national registration is the communication about confidential data and therefore procedure must be well defined and agreed by participating parties

• Common assessment and inspections are useful practice, but not always are applicable


25

Principles of proposed processPrinciples of proposed process

• Availability of PQP assessment, inspection outcomes and advice to facilitate national regulatory decisions making (registrations, variations, withdrawals)

• No interference with national legislation, decision making process and regulatory fees

• Co-operation among product manufacturer (PQP holder), NMRA in interested country and PQP to overcome confidentiality issues and assure information flow

• Procedure applicable for individual products

• Procedure voluntary for manufacturers and NMRAs


26

Steps of the procedure: agreementSteps of the procedure: agreement

• NMRA confirms to WHO PQP its interest to participate in collaborative procedure and respect its conditions - Annex 1


27

Steps of the procedure: agreement Steps of the procedure: agreement

Interested NMRAs agree to participate in the procedure

PQP lists committed NMRAs on its website


28

Steps of the procedure: registration /1 Steps of the procedure: registration /1

1. Manufacturer submits to participating authority the application for national registration of the medicinal product, which underwent WHO PQP assessment/ inspections and is prequalified, and informs the authority about the interest to follow the collaborative procedure - Annex 2

2. Manufacturer informs WHO PQP about the application for national registration and, for each product, provides written agreement to exchange of information between the participating authority and WHO PQP - Annex 3


29

Steps of the procedure: registration /2 Steps of the procedure: registration /2

3. Participating authority informs WHO PQP about its interest to apply the procedure for given medicinal product - Annex 4

4. WHO PQP provides participating authority with the assessment/inspection outcomes and provides additional explanation, if requested

5. Participating NMRA reviews WHO PQP assessment and inspection outcomes and within 90 days decides upon the national registration. Participating NMRA informs WHO PQP about the outcome of national registration and, when divergent from PQP decision, provides explanation - Annex 5


30

Manufacturer informs PQP about national submission and

gives consent with information sharing

Participating NMRA confirms its interest to participate in procedure for specific product

PQP shares with participating NMRA outcomes of assessment and inspections

Participating NMRA reviews WHO PQP outcomes, decides within 90 days decides upon the national registration and informs PQP about its decision

Steps of the procedure: registrationSteps of the procedure: registration

PQ product is submitted for national registration to NMRA participating in the procedure

NMRA is informed about the interest to follow PQP


31

Steps of the procedure: post-registrationSteps of the procedure: post-registration1. PQP provides participating authorities with variation

assessment reports and post-prequalification inspection reports, when regulatory action is deemed to be justified

2. Participating authorities inform PQP about the outcome of national variation procedures, if they have reached a decision different from that reached by PQP, or they reached a decision which results in national registration conditions being inconsistent with prequalification conditions

3. WHO PQP informs participating NMRA about withdrawals, suspensions or de-listings of prequalified medicinal products

4. Participating authority informs PQP about national de-registration (for any reason) of a prequalified medicinal product


32

Steps of the procedure: post-registrationSteps of the procedure: post-registration

PQP informs NMRAs about important variations

NMRAs inform PQP about variations and decisions leading to inconsistency with PQP conditions

WHO PQP informs NMRA about withdrawals, suspensions or de-listings

of prequalified medicinal products

NMRAs inform PQP about national de-registration

Variations

De-registrations and de-listings


33

Steps takenSteps taken• Principles of procedure pre-discussed with several

African NMRAs

• Procedure drafted and internally agreed by PQP team

• Draft discussed at different fora with NMRAs and manufacturers and amended– UNFPA/WHO workshops in Tanzania, Namibia– Regulatory assessors familiar with PQP in Copenhagen

• Pilot to be organized with volunteering NMRAs and manufacturers– Pilot sponsored by Gates Foundation as one of PQP project

activities (2011-2012)


34

Piloting the procedure Piloting the procedure

• Intention to pilot the procedure with several already PQ products; possibility to include parallel submissions later

• Identification of 2-3 piloting countries (NMRAs) in Africa and South-East Asia

• Identification of 2-3 products of 2 manufacturers to volunteer in pilot project

• Review of experience at the meeting of participating countries and manufacturers


35

Win-win outcomes for all stakeholdersWin-win outcomes for all stakeholders• NMRAs

– Availability of WHO assessment and inspection outcomes to support national decisions

– Opportunity for learning from experienced assessors– Saving internal capacities– Demonstrating NMRA efficiency

• WHO– Prequalified medicines are faster available to patients

• Procurers– Faster start of procurement

• Manufacturers– Harmonized data for PQ and national registration– Facilitated interaction with NMRAs in assessment and inspections– Accelerated registration


36

Comments?


37

Thank you for the attentionThank you for the attention

[email protected]@who.int


1 regulatory capacity building and principles of collaboration procedure between the who...

Documents