Accelerated Registration of Prequalified FPPs

Finished pharmaceutical products (FPPs) that are WHO-prequalified have been evaluated and inspected according to international standards. But they must still be approved for use by the national medicines regulatory authorities (NMRAs) of the countries for which market entry is sought. Repeating assessment and inspection of those FPPs not only consumes scarce regulatory resources but also extends the time needed to make them available to patients. WHO has therefore designed a collaborative procedure that both enables NMRAs to make use of work already carried out by WHO and to strengthen their own regulatory oversight processes, in line with international best practices. Of greatest interest to manufacturers is that application of the procedure enables faster registration.

The procedure (Collaborative Procedure between the World Health Organization Prequalification of Medicines Programme and National Medicines Regulatory Authorities in the Assessment and Accelerated National Registration of WHO-prequalified Pharmaceutical Products) is open to NMRAs in all WHO Member States and holders of prequalified FPPs, on a voluntary basis, and its principles are a model for other regulatory collaborative initiatives.

How does it work?

An FPP that in all essential features is the same as the prequalified FPP is submitted for national registration in a country, the NMRA of which, is participating in the collaborative procedure. The countries of NMRAs that are currently participating in the procedure are listed in the Participating Countries table in this section. Additional NMRAs may be invited to participate by WHO if applicants express interest in registering their FPPs in countries the NMRAs of which are not yet participating in the procedure.

Applicants (generally companies) voluntarily express interest in applying the procedure for accelerated registration to their prequalified products. Applicants authorize WHO to share its assesment and inspection outcomes for the specific product(s), with the NMRA(s), of the country in which accelerated registration is sought. An applicant must submit the same dossier as the one approved by WHO for prequalification, although individual NMRAs may agree to submission of simplified dossiers and minor administrative differences are permitted, to reflect local labelling and other regulatory requirements. The technical part of the dossier should be updated to reflect the data as approved by WHO during prequalification, any WHO-approved variations and requalification (where applicable). If, at the time of submission, any variations await WHO prequalification approval, the applicant should inform the NMRA accordingly. (National rules for submission of applications and regulatory fees will apply.)

WHO then shares information regarding its evaluation of the FPP for prequalification (i.e. assessment and inspection outcomes) with the NMRA. The information is shared via a secure internet-based platform, subject to confidentiality undertakings and agreed restrictions on use. Within the NMRA, only the designated focal person(s) can access the information.

The NMRA can, of course, decline to apply the collaborative procedure to the FPP. If so, it will be requested to indicate to WHO its reasons for not doing so. Similarly, if it declines to register the FPP on the basis of the information it received about the prequalified FPP, or if the terms of its decision deviate from those of prequalification, it will be requested to give its reasons for reaching a conclusion that differs from that of WHO.

How long does it take?

If the NMRA of the country in which registration of the prequalified FPP is sought agrees to apply the procedure to the product concerned, it commits to reaching its decision within 90 days of receiving access to the assessment and inspection information, as to whether it will register the FPP, and to communicate its decision to WHO and the applicant within a further 30 days.

What happens following collaborative registration of a product?

After granting of national registration, WHO will add the relevant product to its list of prequalified products that have been registered under the collaborative procedure. This list is publicly available on this website. Thereafter the NMRA must inform WHO of any post-approval changes (variations) made to the nationally-registered product. These changes must follow those approved by WHO to ensure that consistency between the prequalified product and the nationally-registered product is maintained. Some changes (deviations) are acceptable e.g. in labelling or product information. However, changes relating to quality aspects, and as defined in the guideline for sameness, will mean that the nationally-registered product is no longer considered to be the same as the prequalified product.

What are the benefits of the procedure?

  • Shorter time to registration, thereby products can enter the market and and be made available to health care providers and patients more quickly.
  • Less duplication of work for applicants in terms of preparation of dossiers: participating NMRAs largely accept submissions already approved by WHO, that is, in the same CTD format as requested by WHO.
  • NMRAs save resources since they do not need to carry out a full assessment of the prequalified product or to inspect its manufacturing sites.
  • Opportunities for work sharing between WHO and NMRAs when assessing variations, carrying out follow-up inspections, or organizing sample testing by prequalified quality control laboratories.
  • Capacity building at the participating NMRAs: prequalification reports (dossier evaluation, inspection reports and test results) are available to staff, providing excellent examples of assessment and inspection carried out to international standards.
  • Transparency for buyers: products registered through the collaborative procedure are in all essential features the same as the related WHO-prequalified products and are, in effect, regulated by both WHO and the relevant NMRA(s).

What happens if an NMRA deregisters a collaboratively-registered product?

The NMRA will inform the WHO Prequalification Team: medicines (PQTm) of the deregistration within 30 days, or as soon as possible in cases where patient safety may be affected. PQTm encourages NMRAs to consult with prequalification experts before de-registering a prequalified product. If PQTm remains assured about product quality, de-registration does not affect the product’s prequalification status.

What happens if WHO suspends or de-lists a prequalified product?

Suspension or de-listing of a prequalified product may occur:

  • at the request of the applicant
  • or due to concerns about quality, safety or efficacy.

In the latter case PQTm will post information about the suspension or de-listings on its website, and related additional information such as the latest inspection report on the secure internet-based platform used for the collaborative procedure. Additionally, it will alert NMRAs that have registered the product under the collaborative procedure.

 

Download List

Country / Regulatory Authority / Address Date of Participation Agreement Web details

Armenia

The Scientific Centre for Drug and Technology Expertise of the Ministry of Health
49/4 Komitas Ave, 0051
Yerevan

20-May-14 Website
Medicines registration 

Botswana

Drugs Regulatory Unit (DRU) of the Ministry of Health
3D5 Ministry of Health HQ, Government Enclave, Private Bag 0038
Gaborone

27-Jun-12 Website  
Services – Regulatory
Services – Drug regulation services

Burkina Faso

Direction générale de la pharmacie, du médicament et des laboratoires (DGPML) 
03 B.P. 7009
Ouagadougou

16-Oct-14 Website

Burundi

Department of Pharmacy, Medicines and Laboratory, Ministry of Health
B.P. 1820
Bujumbura

04-May-15 Website

Caribbean Community (CARICOM)

Caribbean Public Health Agency (CARPHA)/Caribbean Regulatory System (CRS),
16-18 Jamaica Blvd, Federation Park
Port of Spain (Trinidad and Tobago)

* See list of member states and associate member states below this table.
07-Dec-16 Website

Cameroon

Direction de la pharmacie, du médicament et des laboratoires (DPML)
Mballa 2
Yaoundé

24-Nov-14  

Côte d'Ivoire

Direction de la pharmacie et du médicament (DPM)
52, Boulevard de Marseille, B.P. V 5
Abidjan

05-Nov-14 Website
Documents publics - Médicament

Democratic Republic of the Congo

Direction de la Pharmacie et du Médicament (DPM)
B.P. 11998
Kinshasa I

05-Jul-14 Website

Eritrea

National Medicines and Food Administration, MoH
Denden 174-4, P.O. Box 212
Asmara

02-May-17  

Ethiopia

Food, Medicine and Healthcare Administration and Control Authority of Ethiopia (EFMHACA)
P.O. Box 5681
Addis Ababa

21-Mar-14 Website
Directives, standards and guidelines

Georgia

State Regulatory Agency for Medical Activities
144, Ak. Tsereteli Ave.
Tbilisi, 0119

17-Oct-13 Website

Ghana

Food and Drugs Board (FDB)
PO Box CT 2789, Cantonment
Accra

18-Jun-12 Website
Downloads - Operational guidelines

Kenya

Pharmacy and Poisons Board
Lenana Road, Opp. DOD; P.O. Box 27663-00506
Nairobi

06-Jul-12 Website
Resources - Downloads

Kyrgyzstan

Department of Drug Provision and Medical Equipment under Ministry of Health
25 Tretiya Liniya, 720044
Bishkek

31-May-13 Website

Lao People's Democratic Republic

Food and Drug Department
Simuang Road
Vientiane

05-May-16  

Madagascar

Agence du Médicament de Madagascar
Rue Karija – Tsaralalana – BP 8145
Antananarivo – 101

31-Jul-13 Website   

Malawi

Pharmacy, Medicines and Poisons Board
PO Box 30241
Lilongwe

23-Apr-14  

Mali

Direction de la Pharmacie et du Médicament
BPE 5202
Bamako

09-Dec-15  

Mozambique

Departamento Farmacêutico - Misau
Av Salvador Allende / Agostinho Neto
Maputo

31-Oct-13  

Namibia

National Medicines Regulatory Agency
Harvey Street 20, Private Bag 13198
Windhoek

24-Aug-12 Website

Nigeria

National Agency for Food and Drug Administration (NAFDAC)
Plot 445, Herbert Macaulay Road, Yaba
Lagos

30-Jul-12 Website
Guidelines - Drug guidelines 

Pakistan

Drug Regulatory Authority of Pakistan (DRAP)
TF Complex, G9/4
Islamabad

23-Feb-18 Website
 

Philippines

Food and Drug Administration
Civic Drive, Filinvest Corporate City, Alabang 1781
Muntinlupa City

08-Oct-15 Website

Senegal

Direction de la Pharmacie et du Médicament
B.P. 6150; 153 Rue Moussé Diop angle Victor Hugo
Dakar

05-May-15 Website

Sierra Leone

Pharmacy Board of Sierra Leone
Central Medical Stores, New EnglandVille
Freetown

14-Aug-14 Website
Downloads - Guidelines

South Africa

Medicines Control Council (MCC)
National Department of Health
Private Bag X828
Pretoria

14-Dec-16 Website

Sri Lanka

National Medicines Regulatory Authority (NMRA)
N°120, Norris Canal Road
Colombo

08-Sept-17 Website

Tanzania

Tanzania Food and Drugs Authority (TFDA)
PO Box 77150
Dar Es Salaam

06-Jul-12 Website
Information Center – Medicines downloads - Guidelines

Thailand

Thailand Food and Drug Administration
88/24 Tiwanon Road
Nonthaburi

25-Sept-17 Website

Uganda

National Drug Authority (NDA)
Plot 46/48 Lumumba Avenue, PO Box 23096
Kampala

15-Jun-12 Website
Departments - Drug registration

Ukraine

The State Expert Centre of the Ministry of Health of Ukraine
40, Ushynskyi
03151 Kyiv

14-Oct-13 Website
Regulations

Zambia

Zambia Medicines Regulatory Authority (ZAMRA)
PO Box 31890
Lusaka

04-Jul-12 Website 
Guidelines

Zanzibar

Zanzibar Food and Drugs Board
PO Box 3595
Zanzibar

31-Jul-12 Website
Documents  – Documents downloads

Zimbabwe

Medicines Control Authority of Zimbabwe (MCAZ)
106 Baines Avenue
Harare

27-Jun-12 Website
How we regulate  – Evaluation/Registration
*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

Web details were verified by WHO at the time of inclusion in the above table but welcomes any updates. Please send these to prequalreg@who.int

How can NMRAs apply to participate?

Any NMRA that would like to participate in the collaborative procedure for accelerated registration should email:

  • a signed and scanned participation agreement (Appendix 1, Part A)
  • a signed confidentiality undertaking (Appendix 1, Part B) for each designated focal point who is to be granted permission to the restricted-access website for the purpose of downloading and uploading information and reports about FPPs that have been submitted for consideration for collaborative registration

to prequalreg@who.int.

The signed originals of the documents should be posted or sent by courier to:

World Health Organization
Mrs Dilber Gunlu, Room L256
20 Avenue Appia
1211 Geneva 27
Switzerland.

What is the procedure for submitting prequalified FPPs for accelerated registration?

In order to submit a prequalified FPP for registration in any country, the NMRA of which is participating in the procedure, the applicant (usually the manufacturer)  should sign and email a consent form (Appendix 2) (one form per country) to prequalreg@who.int. This will serve to grant WHO permission to share its evaluation information with the NMRA. The signed originals of the consent form should be posted or sent by courier to:

World Health Organization
Mrs Dilber Gunlu, Room L256
20 Avenue Appia
1211 Geneva 27
Switzerland.

Additionally, the applicant should submit an expression of interest in having the procedure applied to the FPP by completing Appendix 3, Part A and submitting it to the relevant NMRA. It should also email a completed Appendix 3, Part A to prequalreg@who.int.

The expression of interest (Appendix 3, Part A) should be submitted to the NMRA in addition to the national registration documents it requires (and irrespective of whether the application is new or pending).

Any differences between the prequalified dossier/data and the national submission should be stated as requested by Appendix 3, Part A.  When a request is made for application of the procedure to a pending registration submission, the advice of the NMRA should be sought before submission.

What happens following the request for application of the procedure?

Following a request for application of the procedure:

  • The NMRA agrees (or refuses, and gives a justification for its refusal) to apply the procedure to the FPP. It completes Appendix 3, Part B, provides it to WHO via the confidential restricted-access MedNet website — Collaborative Registrations Community — and informs the applicant that it has done so. Alternatively, the NMRA can convey the information to WHO by e-mail (prequalreg@who.int).
  • WHO shares with the NMRA information relating to its evaluation of the FPP for prequalification and any variations (if applicable) via MedNet.
  • The NMRA evaluates the product using the information provided by WHO, at its discretion, and makes its registration decision within 90 days of regulatory time; regulatory time starts after a valid application for the registration according to the procedure has been received and access to the confidential information has been granted (whichever is the later) and continues until the date of decision on registration. The regulatory time does not include the time granted to the applicant to complete missing parts of documentation, provide additional data or respond on queries raised by NMRAs.
  • The NMRA, within a further 30 days, informs the applicant of its regulatory decision, and completes Appendix 3, Part C and provides it to WHO via MedNet or by e-mail (prequalreg@who.int)..
  • WHO adds the newly registered FPP to the list of products registered via the collaborative procedure.
  • The NMRA, WHO and the prequalification holder collaborate to minimize post-approval differences between the prequalified and nationally-approved FPP and keep themselves informed throughout the post-registration phase regarding relevant variations made to the product, withdrawal, suspension, delisting from the WHO List of Prequalified Medicinal Products or national deregistration.NMRAs keep WHO informed by using Appendix 4 and forwarding it to WHO via MedNet or by e-mail.

 

FAQ: WHO collaborative procedure between WHO and national medicines regulatory authorities in assessment and accelerated national registration (16 May 2018)

Full text of the procedure