Pre Qualification Of Medicines By WHO

Key Facts

  • Every year, billions of US dollars worth of medicines are purchased by or through international procurement agencies – such as UNICEF, the Global Fund to Fight AIDS, Tuberculosis and Malaria, and UNITAID – for distribution in resource-limited countries.
  • The WHO Prequalification of Medicines Programme (PQP) helps ensure that medicines supplied by procurement agencies meet acceptable standards of quality, safety and efficacy.
  • At the end of 2012, the WHO List of Prequalified Medicinal Products contained 316 medicines for priority diseases.
    WHO's list of prequalified medicinal products is used by international procurement agencies and increasingly by countries to guide bulk purchasing of medicines.
  • PQP also prequalifies active pharmaceutical ingredients and quality control laboratories.

WHO prequalification of medicines is a service provided by WHO to assess the quality, safety and efficacy of medicinal products. Originally, in 2001, the focus was on medicines for treating HIV/AIDS, tuberculosis and malaria. In 2006, this was extended to cover medicines and products for reproductive health and again in 2008, to cover prequalification of zinc, for managing acute diarrhoea in children. At the end of 2012, the WHO List of Prequalified Medicinal Products contained 316 medicines for priority diseases.

Every year, billions of US dollars worth of medicines are purchased by international procurement agencies for distribution in resource-limited countries. Prequalification is intended to give these agencies the choice of a wide range of quality medicines for bulk purchase.

The WHO prequalification of medicines process:
how does it work?
Prequalification consists of five components.

1. Invitation
The WHO Prequalification of Medicines Programme (PQP), other UN agencies (UNAIDS and UNICEF) and UNITAID, issue an invitation to manufacturers to submit an expression of interest (EOI) for product evaluation. Only products included in an EOI are eligible for prequalification.

The inclusion of a medicine in an EOI is based on one or more of three criteria:

it is listed on the WHO Model List of Essential Medicines;
an application for its addition to the Model List has been submitted to the relevant WHO Expert Committee for assessment, and is likely to meet the criteria for inclusion (based on public health need, comparative effectiveness, safety and cost-effectiveness);
it is recommended for use by a current WHO treatment guideline.

2. Dossier submission
The manufacturer provides a comprehensive set of data about the quality, safety and efficacy of the product submitted for evaluation. This includes:

data on the purity of all ingredients used in manufacture;
data on the finished pharmaceutical product (such as information about stability); results of bioequivalence tests (clinical trials conducted in healthy volunteers), unless waived.

3. Assessment
A team of assessors evaluates all the data presented. Assessment teams include WHO staff and experts from national regulatory authorities worldwide.

4. Inspection
A team of inspectors verifies that the manufacturing sites for the finished pharmaceutical product and its active pharmaceutical ingredient(s) comply with WHO good manufacturing practice. They also verify that any contract research organization that conducted any clinical studies relating to the submitted product complies with WHO good clinical practice and WHO good laboratory practice.

5. Decision
If the product is found to meet the specified requirements, and the associated manufacturing site(s) and contract research organization(s) are compliant with WHO standards, the product is added to the WHO list of prequalified medicinal products.

The WHO prequalification of medicines process can take as little as three months, provided the data presented are complete and demonstrate that the product meets all required standards. If data are insufficient, however, the process can take considerably longer since the manufacturer must submit the necessary data for reassessment.

To ensure that prequalified products continue to meet WHO specifications, PQP regularly re-inspects manufacturing sites of prequalified products. It also evaluates any changes (known as "variations") made to specifications, manufacturing processes and quality control of prequalified products, and conducts random quality control tests on sampled prequalified products.

We plan to do einterviews with MBBS doctors to understand 4 things
1) Tests or questions you ask in first few meetings
2) What it means in medical terms
3) What it means in non medical terms
4) What should the patient or care takers do

We might interview Aurvedic doctors, homeopathic doctors, Yoga teachers on this health issue

Video links
The WHO PQ Collaborative Procedure for Accelerated Registration

Capacity Buildung within the Context of the WHO Prequalification Program
Brief sponsor information