Asia Pacific Regulatory Mechanisms

Country Case Studies

Thailand Case Study

The Bureau of Cosmetics and Hazardous Substances Control of the Food and Drug Administration oversees the regulation of vector control products in Thailand. The registration process for vector control products in Thailand sees effective collaboration between different ministries through the Hazardous Substance Committee. Case study will be available soon! Sign up as a VCAP member to receive an update when the case study is published.

Thailand Case Study

Malaysia Case Study

In Malaysia, vector control tools are regulated by the Pesticide Board under the Department of Agriculture. There exists well-defined processes and guidelines for the registration of vector control products. Malaysia’s acceptance of regional toxicology data and policy of not mandating in-country trials saves cost for the manufacturer reduces cost for the manufacturers and also reduces the timeline shortens the lead time to get urgent vector control products to market.

Malaysia Case Study

Introduction of vector control products

Access Roadmap

Access Roadmaps for the introduction of vector control tools provide a high-level overview of the policies and regulations involved in the registration and introduction of vector control products in a country.  The first Access Roadmap will be on Cambodia. Sign up as a VCAP member to receive an update whenever a Access Roadmap for a country is published.
GLOBAL EVALUATION OF VECTOR CONTROL PRODUCTS

The WHO Prequalification process

The World Health Organization (WHO) prequalification of Vector Control Products (VCPs) is a comprehensive assessment of  individual products through a standardized procedure aimed at ensuring the efficacy, safety and quality of VCPs of public health value meet international WHO acceptance criteria.

The WHO prequalification of VCPs is coordinated through the department of Essential Medicines and Health Products. It is overseen by the Prequalification Team Vector Control Group (PQT-VC).

The process for the evaluation of vector control products has transitioned from the WHO Pesticide Evaluation Scheme (WHOPES) to the WHO Prequalification (PQ) process in 2018.

The PQ process was initially put in place as a prequalification for procurement by UN agencies, but with its international recognition and process transparency, has increasingly been recognised as a trusted prequalification tool by national regulators, disease programs, philanthropic organisations and other international procurement agencies.

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A report by IVCC

Vector Control Regulatory Landscape in Asia Pacific

The Australian Government’s Indo-Pacific Centre for Health Security awarded the Innovative Vector Control Consortium (IVCC) a 5-year grant for the development of a vector control product toolbox for the Indo-Pacific Region. The IVCC commissioned landscape studies of the region to map the technical gaps for vector control in key countries and to evaluate the regulatory requirements and different routes to market. The regulatory landscaping study delves deep into the regulatory pathways for vector control tools for Cambodia, Vietnam, Myanmar, Malaysia, Indonesia and Papua New Guinea.

In Asia Pacific, most regulatory agencies responsible for vector control (VC) tools in the region do not sit within Ministries of Health but instead sit within Ministries of Agriculture or Environment. In some cases, this means that public health pesticides evaluations are based on the regulatory framework for agricultural pesticides. This highlights the need to work with stakeholders beyond Ministries of Health to improve access to effective VC tools. This is to ensure that the VC tools and solutions in place adequately answer to the health needs of the people in Asia Pacific.

Some of the challenges identified in the report, with respect to the registration of VC tools in the region include:

  • Referral guidelines and specifications for some pesticides are not uniform across the region
  • there is limited awareness of and compliance with international regulatory norms and standards
  • Data requirements for registration vary from country to country. Regional or global trial data is not accepted in some countries. Sometimes even if a product is WHO pre-qualified, additional local trials are required before it is registered
  • The evaluation process is time consuming, without clear guidelines on accelerating the review process for urgent public health pesticides.
  • Coordination and collaboration between regulatory bodies and disease programs is limited and not systematic
  • Post registration monitoring and implementation of legislation related to poor quality pesticides is lacking.

 

The report suggests ways to strengthen the regulatory pathways for VC products such as adopting the reliance mechanism where registration in one country can lead to efficient registration in a similar country or greater collaboration with the disease programs in an effort to fast-track the registration processes for public health pesticides. To read more about the regulatory and market access landscaping survey results