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PQT/VCP December Update

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VCP Engagement Day in Brasilia
News
Announcement
VCP

2024 PQT/VCP Highlights 

  • In PQT/VCP in 2024, the number of products that were prequalified increased by 75% compared to 2023, with a 19% average decrease in time to prequalification.  

  • The potential for the benefits of PQ for VCPs was highlighted through the first NRA registration of a VCP under CRP.  The national registration was completed in 28 days. 

  • The pool of expert assessors supporting the PQT/VCP work was expanded and currently includes 48% female and 61% Global South representation with members representing all six regions of WHO.  

  • The 2024 accomplishments of PQT/VCP and impact in increasing access to quality assured products were a result of the strong partnerships and engagement with internal and external stakeholders. 


 

Recently prequalified products 

Over the last 4 months, PQT/VCP has prequalified three new ITNs: Yahe 4.0 (Fujian Yamei Industry & Trade Co. Ltd), an incorporated pyrethroid and PBO ITN; Yorkool G5 (Tianjin Yorkool International Trading Co., Ltd), a coated alpha-cypermethrin and chlorfenapyr ITN, and GreenNet (Shobikaa Impex Private Limited), a coated deltamethrin ITN made from recycled polyester. 

One new IRS product using a new active ingredient has been prequalified: Sylando 240SC (BASF Agro B.V Arnhem (NL) Freienbach Branch – RA) 

Three ITN products have been transferred from ownership of DCT to Mainpol GMBH: Royal Sentry 2.0, Royal Guard, and Vector Guard, renamed SafeNet Plus. 

Further details can be found on the prequalification page for each product. 

 

Product type 

Product name 

Date of prequalification 

Newly prequalified product - ITN 

11 November 2024 

Newly prequalified product - ITN 

16 September 2024 

Newly prequalified product - ITN 

16 August 2024 

Newly prequalified product - IRS 

05 December 2024 

Transfer of ownership - ITN 

6 February 2019 

Transfer of ownership - ITN 

29 March 2019 

Transfer of ownership - ITN 

ShapeVector Guard            SafeNet Plus 

9 January 2024 


 

New pipeline products

Newly accepted products into the PQT/VCP pipeline are: Guardian (SC Johnson), a spatial repellent containing transfluthrin; UNET G1 LN (Sino Africa Medical Devices Company Ltd - RA), an ITN treated with deltamethrin; UNET G3 LN (Sino Africa Medical Devices Company Ltd - RA), and ITN treated with deltamethrin and PBO and UNET G5 LN (Sino Africa Medical Devices Company Ltd – RA) an ITN treated with alpha-cypermethrin and chlorfenapyr. 

 

Product type 

Product name 

Date of acceptance for assessment 

Spatial repellent 

Guardian 

01 November 2024 

ITN 

UNET G1 LN 

20 November 2024 

ITN 

UNET G3 LN 

20 November 2024 

ITN 

UNET G5 LN 

20 November 2024 

 

All products that have been accepted for PQT/VCP assessment can be found on the pipeline page. 

PQT/VCP target timelines for assessment and listing decision(s) are 365 WHO days from the date of acceptance for assessment. WHO days are defined as those days in which the product dossier is with WHO for assessment, i.e., does not include manufacturer time to respond to Requests for Information.  


 

Recently withdrawn products 

Four products have been withdrawn from prequalification by manufacturers: Royal Sentry (ITN, withdrawn by DCT), Aqua Reslin Super (withdrawn by Envu), and Yorkool LN (ITN, withdrawn by Tianjin Yorkool International Trading Co., Ltd), Tsara Net (ITN, withdrawn by PPP Hollandi).  

  

Product type 

Product name 

PQT/VCP ID 

Date of withdrawal 

ITN 

Royal Sentry 

003-001 

07 November 2024 

Space spray 

Aqua Reslin Super 

P-00160 

25 November 2024 

ITN 

Yorkool LN 

021-001 

10 December 2024 

ITN 

Tsara Net 

P-00224 

12 December 2024 

 

Any products produced in compliance with the prequalification decision prior to the date of withdrawal are considered to be covered by the prequalification decision. 

For any questions pertaining to recently withdrawn products, including references to previously published documents, please contact pqvectorcontrol@who.int .


 

Recently published documents 

Two generic risk assessments (GRAs) have been published for ITNs: Chlorfenapyr and Pyriproxyfen.  

GRAs are intended to be used by applicants, regulatory authorities, and other stakeholders as examples of the implementation of the Generic risk assessment model for Insecticide-Treated Nets, 2nd edition (WHO, 2018).  They use representative values which exemplify currently prequalified ITN products for specific active ingredients to characterize the hazards, exposure, and risk. 

All of the generic risk assessments for ITNs are located on the ITN Guideline page of the PQT/VCP website. 

The lambda-cyhalothrin specification has been updated with the publication of the CS formulation specification and updated WP and WP-SB formulation specifications. 

The chlorfenapyr specification has been updated with the extension of the existing WHO chlorfenapyr TC specification to encompass the technical material produced by Tagros Chemicals India Pvt. Ltd. 

The spinosad specification GR, SC, DT, EC formulation specifications have been updated with revised CIPAC methods. 

The ethyl butylacetylaminopropionate specification has been updated with the extension of the existing WHO ethyl butylacetylaminopropionate TC specification to encompass the technical material produced by Hunan Xuetian Fine Chemical Industry Co., Ltd. 


 

Updated documents 

Two implementation guidance documents for ITNs have been updated with minor changes. 

The ITN guideline and all associated implementation guidance documents can be found here. 

The specification templates for proposers have been updated to reflect the most recent reference analytical methods (as per the templates' publication date).  As such, users of the Chemical and Microbial manuals are encouraged to refer to the templates as a reference point to identify if updated analytical methods are available. 

 

Document type 

Title 

Implementation guidance - ITNs 

Implementation guidance - ITNs 

Specification Templates for Proposers 

Technical Materials - Chemical and Microbial 

Formulated Chemical Product Specification Templates 

Formulated Microbial Product Specification Templates 


 

Meetings and events  

 

 

 

 

 

 

 

          This month, PQT/VCP held its biannual assessors session in Brasilia, Brazil. 

          Expert assessors from 15 countries and four disciplines worked together to 

          advance VCP product assessments. 

 

 

          The next ASVCP (ASVCP 2024.1) is scheduled for 17-21 March 2024 in 

          Manila, Philippines.  

 

 

 

 

In collaboration with the PAHO regional office and the PAHO Brazil country office, on the 19thNovember, PQT/VCP held an engagement day to discuss VCP regulation in the region, data gaps and urgent priorities for novel VCPs. Representatives from PAHO Washington, OPAS Brazil, ANVISA, and the Brazilian Ministry of Health (MoH) were in attendance. Collaborative discussions increased the awareness of the role of PAHO/OPAS in procurement and support to the MoH in supply and quality assurance mechanisms, PQT/VCP processes ANVISA supporting legislation, and MoH VC programmes. Continued support and plans for deepened, cross-cutting engagement among all attendees were pledged. 

 

 

PQT/VCP attended the Joint UNICEF, UNFPA and WHO Meeting with manufacturers and suppliers of in vitro diagnostic products, vaccines & immunization devices, finished pharmaceutical products, active pharmaceutical ingredients, contraceptive devices and vector control products in Copenhagen, Denmark in December 2024. Engagement with manufacturers of vector control products and vector control active ingredients was high, and 21 1-1 pre-submission meetings were held.  

 

Meeting/Event 

Location 

Date 

ASVCP 2024.2 

Brasilia, Brazil 

18-22 November 2024 

PQT/VCP PAHO Engagement Day 

Brasilia, Brazil 

19 November 2024 

Joint UNICEF, UNFPA and WHO meeting with manufacturers and suppliers

Copenhagen, Denmark 

2-6 December 2024 

ASVCP 2025.1 

Manila, Philippines 

17-21 March, 2025 

JMPS 2025 

Galway, Ireland 

11-14 June, 2025 

Joint WHO/FAO/CIPAC Meeting 2025 

Galway, Ireland 

16 June 2025 


 

Technical Advisory Group on WHO Vector Control Products Regulation (TAG-VCPR) 

The Technical Advisory Group on WHO Vector Control Products Regulation (TAG-VCPR) is an advisory group to PQT/VCP. The TAG-VCPR provides: 

  • Regulatory advice on the procedures related to the assessments of vector control products and vector control active ingredients; 

  • Advice on the development, revision and adoption of policies, guidelines and guidance in response to advancements of technologies in vector control and the progression of PQT-VCP activities, such as regulatory frameworks for existing and novel products, and guidelines and guidance (including data requirements) for pre-market assessment; 

  • Provides advice on the workplan and prioritization of activities/initiatives within the scope of prequalification of vector control products and other related activities. 

 

Members of the TAG-VCPR are expected to have senior level expertise in product regulation, product development, vector control, vector control policy development. 

 

A call for applications to the TAG-VCPR is currently active, deadline 31 December 2024. 

 

Individuals from national regulatory authorities from member states of AFRO, EMRO, SEARO, WPRO, PAHO, and EURO, women, and those with expertise in vector control products regulation are particularly encouraged to submit an application.  Individuals with experience relevant to the policy and regulation of pesticides, more generally, and/or health products/technologies which may be related to vector control are also encouraged to express their interest by means of submitting an application.  

 


For further information please visit the WHO Prequalification Unit website at https://extranet.who.int/pqweb  or contact the Team directly at pqvectorcontrol@who.int